Pseudoephedrine Extended Release Oral Tablet

Brand(s)
Sudafed, Sudogest, Wal-Phed
Category(s)
otc
SPL Type(s)
Human OTC
Master SPL
Johnson & Johnson Consumer Inc., Mcneil Consumer Healthcare Division (2010-09-16)
Oldest Current Product
1999-07-21
License(s)
NDA, ANDA
RxNORM
EXTENDED RELEASE ORAL TABLET\PSEUDOEPHEDRINE
FDAOB
ORAL\TABLET, EXTENDED RELEASE\PSEUDOEPHEDRINE HYDROCHLORIDE
SPL Active
ORAL\TABLET, EXTENDED RELEASE\PSEUDOEPHEDRINE HYDROCHLORIDE
ORAL\TABLET, FILM COATED, EXTENDED RELEASE\PSEUDOEPHEDRINE HYDROCHLORIDE
SPL Moiety
ORAL\TABLET, EXTENDED RELEASE\PSEUDOEPHEDRINE
ORAL\TABLET, FILM COATED, EXTENDED RELEASE\PSEUDOEPHEDRINE

product(s) by strength(s)

12 hr pseudoephedrine hydrochloride 120 mg extended release oral tablet

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001130054ANDAL. Perrigo Company1999-10-29PSEUDOEPHEDRINE HYDROCHLORIDEORALTABLET, FILM COATED, EXTENDED RELEASEANDA0751531de8a7f6-e7bb-437d-8794-c4b9f43b89c9
2001132054ANDAL. Perrigo Company2011-10-04PSEUDOEPHEDRINE HYDROCHLORIDEORALTABLET, FILM COATED, EXTENDED RELEASEANDA0751532830cbbc-7309-4dc3-8622-62497e867fe8
3003630054Wal-PhedANDAWalgreens1999-09-24PSEUDOEPHEDRINE HYDROCHLORIDEORALTABLET, FILM COATED, EXTENDED RELEASEANDA07515383022bc1-c372-4c74-93c2-0ed66c57aad3
4003630061Wal-PhedANDAWalgreens1999-09-24PSEUDOEPHEDRINE HYDROCHLORIDEORALTABLET, FILM COATED, EXTENDED RELEASEANDA0751534bb5f838-f628-406a-a6f8-c18cb9637fc2
5003630204Wal-PhedANDAWalgreens2006-04-28PSEUDOEPHEDRINE HYDROCHLORIDEORALTABLET, FILM COATED, EXTENDED RELEASEANDA077442e33d6ca8-7b3c-42ad-85d3-3302a949501e
6009045803SudogestANDAMajor2006-04-28PSEUDOEPHEDRINE HYDROCHLORIDEORALTABLET, FILM COATED, EXTENDED RELEASEANDA0774424ea51d10-4fb8-4fc3-b6b0-1ffef3085b97
7116730054ANDATarget Corp2009-09-02PSEUDOEPHEDRINE HYDROCHLORIDEORALTABLET, FILM COATED, EXTENDED RELEASEANDA07515320a9add0-b240-4f90-a103-2d8d17443514
8116730112ANDATarget Corp2015-03-13PSEUDOEPHEDRINE HYDROCHLORIDEORALTABLET, FILM COATED, EXTENDED RELEASEANDA075153f538238e-b54a-4092-9579-f2ff2bf9f420
9118220054ANDARite Aid2002-08-13PSEUDOEPHEDRINE HYDROCHLORIDEORALTABLET, FILM COATED, EXTENDED RELEASEANDA075153fed52ee7-ba03-4e85-9ec4-0ead6da62212
10118220650ANDARite Aid1999-08-30PSEUDOEPHEDRINE HYDROCHLORIDEORALTABLET, FILM COATED, EXTENDED RELEASEANDA075153aa52d998-cab8-439c-ac95-6c1f5da48ba4
11211300054ANDABetter Living Brands Llc2000-05-25PSEUDOEPHEDRINE HYDROCHLORIDEORALTABLET, FILM COATED, EXTENDED RELEASEANDA075153f5f2efae-276c-4de7-8c17-4e09eb87e827
12211300204ANDABetter Living Brands Llc2006-04-28PSEUDOEPHEDRINE HYDROCHLORIDEORALTABLET, FILM COATED, EXTENDED RELEASEANDA07744201a5d9dd-f123-443b-b968-412c0aadaaa2
13243850054ANDAGood Neighbor Pharmacy1999-08-12PSEUDOEPHEDRINE HYDROCHLORIDEORALTABLET, FILM COATED, EXTENDED RELEASEANDA075153d84a0c76-ad50-4616-9252-84ca25a19ca0
14301420054ANDAKroger1999-12-14PSEUDOEPHEDRINE HYDROCHLORIDEORALTABLET, FILM COATED, EXTENDED RELEASEANDA07515347a88638-3eeb-41b0-968f-ecd863bf895f
15368000054ANDATop Care (Topco Associates Llc)2000-04-25PSEUDOEPHEDRINE HYDROCHLORIDEORALTABLET, FILM COATED, EXTENDED RELEASEANDA0751534841c79a-fb92-4209-929a-e4ea0c4015dd
16370120054ANDAShopko Stores Operating Co, Llc2014-03-10PSEUDOEPHEDRINE HYDROCHLORIDEORALTABLET, FILM COATED, EXTENDED RELEASEANDA075153f0f2f2b5-d015-499f-82e5-b11070fff9e2
17370120204ANDAShopko Stores Operating Co, Llc2006-04-28PSEUDOEPHEDRINE HYDROCHLORIDEORALTABLET, FILM COATED, EXTENDED RELEASEANDA077442ca6d7a50-3e73-4997-b79d-648a733bf856
18372050446ANDACardinal Health1999-07-21PSEUDOEPHEDRINE HYDROCHLORIDEORALTABLET, FILM COATED, EXTENDED RELEASEANDA075153b46a956d-200b-42b9-b996-344d2950aea9
19378080204ANDAH-E-B2006-04-28PSEUDOEPHEDRINE HYDROCHLORIDEORALTABLET, FILM COATED, EXTENDED RELEASEANDA0774426695eb23-9c1b-403f-a2f7-cded16dbece4
20411630054ANDASupervalu, Inc2004-08-10PSEUDOEPHEDRINE HYDROCHLORIDEORALTABLET, FILM COATED, EXTENDED RELEASEANDA075153bd5c2093-f812-4dfe-80ea-68cb4e65a09c
21411900054ANDAWakefern Food Corporation2014-03-25PSEUDOEPHEDRINE HYDROCHLORIDEORALTABLET, FILM COATED, EXTENDED RELEASEANDA075153e815d94d-73dc-49ff-b1cf-1aaccc441a31
22412500054ANDAMeijer Distribution, Inc1999-11-05PSEUDOEPHEDRINE HYDROCHLORIDEORALTABLET, FILM COATED, EXTENDED RELEASEANDA0751538fb2d2cf-d45b-4df4-9a4d-1292a2596445
23412500204ANDAMeijer Distribution, Inc2006-04-28PSEUDOEPHEDRINE HYDROCHLORIDEORALTABLET, FILM COATED, EXTENDED RELEASEANDA077442037b997a-629c-4533-897c-6fb73d256a56
24415200054ANDAFoodhold U.S.A., Llc2004-05-11PSEUDOEPHEDRINE HYDROCHLORIDEORALTABLET, FILM COATED, EXTENDED RELEASEANDA0751538ac0bab6-2338-4374-a149-4abba4e5433c
25425070054ANDAHy-Vee2000-09-11PSEUDOEPHEDRINE HYDROCHLORIDEORALTABLET, FILM COATED, EXTENDED RELEASEANDA0751538c4c786c-2b0f-4a23-a87d-effbcfe0c857
26458020107ANDAPerrigo New York Inc2014-05-24PSEUDOEPHEDRINE HYDROCHLORIDEORALTABLET, FILM COATED, EXTENDED RELEASEANDA0751534a4da1e6-2ad1-47f7-a9b3-7d845962ef3b
27461220166ANDAAmerisource Bergen2006-04-28PSEUDOEPHEDRINE HYDROCHLORIDEORALTABLET, FILM COATED, EXTENDED RELEASEANDA07744234885466-1b89-46b6-9257-07067b111ec6
28490350054ANDAWalmart2000-07-19PSEUDOEPHEDRINE HYDROCHLORIDEORALTABLET, FILM COATED, EXTENDED RELEASEANDA0751537f662a2d-c193-4376-b187-28c92718b014
29493480361ANDASunmark2003-06-24PSEUDOEPHEDRINE HYDROCHLORIDEORALTABLET, FILM COATED, EXTENDED RELEASEANDA07515397c89644-0278-4449-9a1e-fb02467c8621
30497380001ANDAKmart Corp2014-02-18PSEUDOEPHEDRINE HYDROCHLORIDEORALTABLET, FILM COATED, EXTENDED RELEASEANDA07515398d48ec8-ab28-4bfb-b3a4-497fa90bb0f9
31497380009ANDAKmart Corp2015-08-17PSEUDOEPHEDRINE HYDROCHLORIDEORALTABLET, FILM COATED, EXTENDED RELEASEANDA075153d5df61ad-ce0a-4e1c-af46-d571d9d4c3bd
32497380054ANDAKmart Corp2011-03-14PSEUDOEPHEDRINE HYDROCHLORIDEORALTABLET, FILM COATED, EXTENDED RELEASEANDA075153da2f01ec-df18-48a9-8bc7-db6af1c637cc
33505800670SudafedANDAJohnson & Johnson Consumer Inc., Mcneil Consumer Healthcare Division2008-06-01PSEUDOEPHEDRINE HYDROCHLORIDEORALTABLET, FILM COATED, EXTENDED RELEASEANDA073585a110069f-dd9e-45ad-b7db-c5a6be1a1564
34516600492ANDAOhm Laboratories Inc.2006-04-28PSEUDOEPHEDRINE HYDROCHLORIDEORALTABLET, EXTENDED RELEASEANDA077442f398ceab-e3d2-421d-813e-b66369f65472
35553160054ANDADza Brands,2011-07-19PSEUDOEPHEDRINE HYDROCHLORIDEORALTABLET, FILM COATED, EXTENDED RELEASEANDA0751538e2f715e-ee3d-4f6d-9a65-a28a50cdf9c1
36560620054ANDAPublix Super Markets, Inc2000-03-20PSEUDOEPHEDRINE HYDROCHLORIDEORALTABLET, FILM COATED, EXTENDED RELEASEANDA07515306092347-33fe-46b8-829c-70e4ca15ecf2
37560620204ANDAPublix Super Markets, Inc2006-04-28PSEUDOEPHEDRINE HYDROCHLORIDEORALTABLET, FILM COATED, EXTENDED RELEASEANDA0774429a6ece8b-7036-4cad-aeb3-993ef4bf614f
38597790204ANDACvs2006-04-28PSEUDOEPHEDRINE HYDROCHLORIDEORALTABLET, FILM COATED, EXTENDED RELEASEANDA0774423a3d11e5-ebbf-4356-8ae6-4e5656b5644c
39597790703ANDACvs1999-12-01PSEUDOEPHEDRINE HYDROCHLORIDEORALTABLET, FILM COATED, EXTENDED RELEASEANDA07515385955336-3f79-457d-822c-f8be019729d1
40620110087ANDAMckesson (Health Mart)2012-01-11PSEUDOEPHEDRINE HYDROCHLORIDEORALTABLET, FILM COATED, EXTENDED RELEASEANDA075153de7abc65-6399-4379-a570-be05f1f69df0
41638680143ANDAQuality Choice (Chain Drug Marketing Association)2006-04-28PSEUDOEPHEDRINE HYDROCHLORIDEORALTABLET, FILM COATED, EXTENDED RELEASEANDA077442880d368f-0ce3-4993-b5b1-13bf01310516
42680160204ANDAChain Drug Consortium, Llc2006-04-28PSEUDOEPHEDRINE HYDROCHLORIDEORALTABLET, FILM COATED, EXTENDED RELEASEANDA077442aec6412a-b62c-44c8-84f5-77f5fa441028
43692560054ANDAHarris Teeter, Llc2015-06-23PSEUDOEPHEDRINE HYDROCHLORIDEORALTABLET, FILM COATED, EXTENDED RELEASEANDA075153dd524943-bb18-49a4-b88c-0dd5261db111

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1422540359ANDARebel Distributors Corp1999-08-12PSEUDOEPHEDRINE HYDROCHLORIDEORALTABLET, FILM COATED, EXTENDED RELEASE243850054ANDA07515383ae6177-afbb-477f-a5ff-64d48960ffef
2617860453ANDARemedyrepack Inc.2015-10-27PSEUDOEPHEDRINE HYDROCHLORIDEORALTABLET, FILM COATED, EXTENDED RELEASE458020107ANDA07515336aa6003-44cd-4706-b109-5f74e17d3173

24 hr pseudoephedrine hydrochloride 240 mg extended release oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1505800669SudafedNDAJohnson & Johnson Consumer Inc., Mcneil Consumer Healthcare Division2008-10-01PSEUDOEPHEDRINE HYDROCHLORIDEORALTABLET, EXTENDED RELEASENDA0200219991599a-b49b-4ea6-a6e1-c05f0c992f71

application(s)

#idtitleapplicantapprovedapproved drugin other drug docs
1ANDA073585SUDAFED 12 HOURMCNEIL CONSUMER HEALTHCARE1991-10-31ANDA073585_001Pseudoephedrine Oral Tablet
2ANDA075153PSEUDOEPHEDRINE HYDROCHLORIDEPERRIGO CO1999-02-26ANDA075153_001Pseudoephedrine Oral Tablet
3ANDA077442PSEUDOEPHEDRINE HYDROCHLORIDESUN PHARMACEUTICAL INDUSTRIES LTD2005-09-28ANDA077442_001Pseudoephedrine Oral Tablet
4NDA020021SUDAFED 24 HOURJOHNSON AND JOHNSON CONSUMER INC MCNEIL CONSUMER HEALTHCARE DIVISION1992-12-15NDA020021_002Pseudoephedrine Oral Tablet

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1ANDA073585_001OTCPSEUDOEPHEDRINE HYDROCHLORIDE (120MG)ORALTABLET, EXTENDED RELEASETrue1991-10-31SUDAFED 12 HOUR
2ANDA075153_001OTCPSEUDOEPHEDRINE HYDROCHLORIDE (120MG)ORALTABLET, EXTENDED RELEASEFalse1999-02-26PSEUDOEPHEDRINE HYDROCHLORIDE
3ANDA077442_001OTCPSEUDOEPHEDRINE HYDROCHLORIDE (120MG)ORALTABLET, EXTENDED RELEASEFalse2005-09-28PSEUDOEPHEDRINE HYDROCHLORIDE
4NDA020021_002OTCPSEUDOEPHEDRINE HYDROCHLORIDE (240MG)ORALTABLET, EXTENDED RELEASETrue1992-12-15SUDAFED 24 HOUR

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
101a5d9dd-f123-443b-b968-412c0aadaaa2 (view SPL)Drug FactsotcHuman OTCBetter Living Brands LlcMANUFACTURE2015-02-242211300204
2037b997a-629c-4533-897c-6fb73d256a56 (view SPL)Drug FactsotcHuman OTCMeijer Distribution, Incmanufacture2013-05-071412500204
306092347-33fe-46b8-829c-70e4ca15ecf2 (view SPL)Publix Super Markets, Inc. Nasal Decongestant Drug FactsotcHuman OTCPublix Super Markets, Inc2012-01-121560620054
41de8a7f6-e7bb-437d-8794-c4b9f43b89c9 (view SPL)Perrigo Suphedrine 12 Hour Drug FactsotcHuman OTCL. Perrigo Company2009-08-111001130054
520a9add0-b240-4f90-a103-2d8d17443514 (view SPL)Target Corporation 12-hour Nasal Decongestant Drug FactsotcHuman OTCTarget Corp2012-03-192116730054
62830cbbc-7309-4dc3-8622-62497e867fe8 (view SPL)Perrigo 12 Hour Decongestant Drug FactsotcHuman OTCL. Perrigo Company2012-03-151001132054
734885466-1b89-46b6-9257-07067b111ec6 (view SPL)Drug FactsotcHuman OTCAmerisource Bergenmanufacture2012-10-241461220166
836aa6003-44cd-4706-b109-5f74e17d3173 (view SPL)Perrigo Pseudoephedrine Hydrochloride 120 mg Drug FactsotcHuman OTCRemedyrepack Inc.2015-10-271617860453
93a3d11e5-ebbf-4356-8ae6-4e5656b5644c (view SPL)Drug FactsotcHuman OTCCvsmanufacture2013-03-011597790204
1047a88638-3eeb-41b0-968f-ecd863bf895f (view SPL)Kroger Co. 12 Hour Decongestant Drug FactsotcHuman OTCKroger2014-05-202301420054
114841c79a-fb92-4209-929a-e4ea0c4015dd (view SPL)Topco Associates LLC. 12 Hour Decongestant Drug FactsotcHuman OTCTop Care (Topco Associates Llc)2012-03-162368000054
124a4da1e6-2ad1-47f7-a9b3-7d845962ef3b (view SPL)Perrigo Pseudoephedrine Hydrochloride 120 mg Drug FactsotcHuman OTCPerrigo New York Inc2014-05-301458020107
134bb5f838-f628-406a-a6f8-c18cb9637fc2 (view SPL)Walgreen Co. Wal-Phed D Drug FactsotcHuman OTCWalgreens2013-01-211003630061
144ea51d10-4fb8-4fc3-b6b0-1ffef3085b97 (view SPL)Drug FactsotcHuman OTCMajormanufacture2012-07-271009045803
156695eb23-9c1b-403f-a2f7-cded16dbece4 (view SPL)Drug FactsotcHuman OTCH-E-Bmanufacture2012-09-191378080204
167f662a2d-c193-4376-b187-28c92718b014 (view SPL)Wal-Mart Suphedrine Drug FactsotcHuman OTCWalmart2011-11-081490350054
1783022bc1-c372-4c74-93c2-0ed66c57aad3 (view SPL)Walgreen Co. Wal-Phed Drug FactsotcHuman OTCWalgreens2009-08-111003630054
1883ae6177-afbb-477f-a5ff-64d48960ffef (view SPL)Nasal Decongestant Drug FactsotcHuman OTCRebel Distributors CorpRELABEL, REPACK2012-12-251422540359
1985955336-3f79-457d-822c-f8be019729d1 (view SPL)CVS Pharmacy, Inc. 12 Hour Nasal Decongestant Drug FactsotcHuman OTCCvs2015-08-034597790703
20880d368f-0ce3-4993-b5b1-13bf01310516 (view SPL)Drug FactsotcHuman OTCQuality Choice (Chain Drug Marketing Association)manufacture2012-09-131638680143
218ac0bab6-2338-4374-a149-4abba4e5433c (view SPL)American Sales Company Suphedrine Drug FactsotcHuman OTCFoodhold U.S.A., Llc2012-03-162415200054
228c4c786c-2b0f-4a23-a87d-effbcfe0c857 (view SPL)Hy-Vee, Inc. Nasal Decongestant Drug FactsotcHuman OTCHy-Vee2012-03-151425070054
238e2f715e-ee3d-4f6d-9a65-a28a50cdf9c1 (view SPL)DZA Brands, LLC 12 Hour Nasal Decongestant Drug FactsotcHuman OTCDza Brands,2011-08-251553160054
248fb2d2cf-d45b-4df4-9a4d-1292a2596445 (view SPL)Meijer Distribution, Inc. 12 Hour Decongestant Drug FactsotcHuman OTCMeijer Distribution, Inc2014-12-162412500054
2597c89644-0278-4449-9a1e-fb02467c8621 (view SPL)McKesson Sinus 12 Hour Drug FactsotcHuman OTCSunmark2012-03-152493480361
2698d48ec8-ab28-4bfb-b3a4-497fa90bb0f9 (view SPL)Kmart Corporation Nasal Decongestant Drug FactsotcHuman OTCKmart Corp2014-02-181497380001
279991599a-b49b-4ea6-a6e1-c05f0c992f71 (view SPL)SUDAFED 24 HOURotcHuman OTCJohnson & Johnson Consumer Inc., Mcneil Consumer Healthcare Division2010-09-161505800669
289a6ece8b-7036-4cad-aeb3-993ef4bf614f (view SPL)Drug FactsotcHuman OTCPublix Super Markets, Incmanufacture2013-01-031560620204
29a110069f-dd9e-45ad-b7db-c5a6be1a1564 (view SPL)SUDAFED 12 HOURotcHuman OTCJohnson & Johnson Consumer Inc., Mcneil Consumer Healthcare Division2015-11-138505800670
30aa52d998-cab8-439c-ac95-6c1f5da48ba4 (view SPL)Rite Aid Corporation Sinus Pressure & Congestion Relief Drug FactsotcHuman OTCRite Aid2013-04-091118220650
31aec6412a-b62c-44c8-84f5-77f5fa441028 (view SPL)Drug FactsotcHuman OTCChain Drug Consortium, LlcMANUFACTURE2015-10-073680160204
32b46a956d-200b-42b9-b996-344d2950aea9 (view SPL)Cardinal Health 12 Hour Nasal Decongestant Drug FactsotcHuman OTCCardinal Health2012-02-161372050446
33bd5c2093-f812-4dfe-80ea-68cb4e65a09c (view SPL)SuperValu Inc. 12 Hour Decongestant Drug FactsotcHuman OTCSupervalu, Inc2014-08-282411630054
34ca6d7a50-3e73-4997-b79d-648a733bf856 (view SPL)Drug FactsotcHuman OTCShopko Stores Operating Co, Llcmanufacture2013-03-251370120204
35d5df61ad-ce0a-4e1c-af46-d571d9d4c3bd (view SPL)Kmart Corporation Sinus 12 Hour Drug FactsotcHuman OTCKmart Corp2015-08-171497380009
36d84a0c76-ad50-4616-9252-84ca25a19ca0 (view SPL)Amerisource Bergen Nasal Decongestant Drug FactsotcHuman OTCGood Neighbor Pharmacy2012-03-141243850054
37da2f01ec-df18-48a9-8bc7-db6af1c637cc (view SPL)Kmart Corporation 12 Hour Decongestant Drug FactsotcHuman OTCKmart Corp2012-10-022497380054
38dd524943-bb18-49a4-b88c-0dd5261db111 (view SPL)Harris Teeter, LLC Sinus 12 Hour Drug FactsotcHuman OTCHarris Teeter, Llc2015-06-291692560054
39de7abc65-6399-4379-a570-be05f1f69df0 (view SPL)McKesson Nasal Decongestant Drug FactsotcHuman OTCMckesson (Health Mart)2012-03-141620110087
40e33d6ca8-7b3c-42ad-85d3-3302a949501e (view SPL)Drug FactsotcHuman OTCWalgreensMANUFACTURE2015-04-131003630204
41e815d94d-73dc-49ff-b1cf-1aaccc441a31 (view SPL)ShopRite Nasal Decongestant Drug FactsotcHuman OTCWakefern Food Corporation2014-05-201411900054
42f0f2f2b5-d015-499f-82e5-b11070fff9e2 (view SPL)Shopko Nasal Decongestant Drug FactsotcHuman OTCShopko Stores Operating Co, Llc2015-03-182370120054
43f398ceab-e3d2-421d-813e-b66369f65472 (view SPL)DRUG FACTSotcHuman OTCOhm Laboratories Inc.manufacture2012-01-201516600492
44f538238e-b54a-4092-9579-f2ff2bf9f420 (view SPL)Target Corporation Sinus 12 Hour Drug FactsotcHuman OTCTarget Corp2015-03-131116730112
45f5f2efae-276c-4de7-8c17-4e09eb87e827 (view SPL)Safeway Inc. 12 Hour Nasal Decongestant Drug FactsotcHuman OTCBetter Living Brands Llc2012-03-162211300054
46fed52ee7-ba03-4e85-9ec4-0ead6da62212 (view SPL)Rite Aid Corporation Suphedrine Drug FactsotcHuman OTCRite Aid2012-03-152118220054

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII