Promethazine Rectal Suppository

Brand(s)
Phenadoz, Phenergan, Promethegan
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Perrigo New York Inc (2015-04-28)
Oldest Current Product
1987-08-31
License(s)
ANDA
RxNORM
RECTAL SUPPOSITORY\PROMETHAZINE
FDAOB
RECTAL\SUPPOSITORY\PROMETHAZINE HYDROCHLORIDE
SPL Active
RECTAL\SUPPOSITORY\PROMETHAZINE HYDROCHLORIDE
SPL Moiety
RECTAL\SUPPOSITORY\PROMETHAZINE

product(s) by strength(s)

promethazine hydrochloride 12.5 mg rectal suppository

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005747236PhenadozANDAPaddock Laboratories, Llc2003-06-24PROMETHAZINE HYDROCHLORIDERECTALSUPPOSITORYANDA0404799aa7b3f2-4429-4a61-ad8e-876afb14cc45
2005912160PhenadozANDAWatson Laboratories, Inc.2013-02-12PROMETHAZINE HYDROCHLORIDERECTALSUPPOSITORYANDA040479c293895b-1010-4283-9228-1184f01a0ef0
3005912985PhenadozANDAWatson Laboratories, Inc.2015-03-16PROMETHAZINE HYDROCHLORIDERECTALSUPPOSITORYANDA040428e3cbbde7-2822-4d4c-bed7-36cf90df1715
4007130536PrometheganANDAG&W Laboratories, Inc.2004-02-28PROMETHAZINE HYDROCHLORIDERECTALSUPPOSITORYANDA0404285f079815-f48b-8b21-2130-7f791d967c9a
5400760318PhenerganANDAPrestium Pharma, Inc.2014-08-01PROMETHAZINE HYDROCHLORIDERECTALSUPPOSITORYANDA0404281fb782f2-37e3-0803-e2da-12a7c5b7bde2
6400850218ANDARenaissance Pharma, Inc.2014-08-01PROMETHAZINE HYDROCHLORIDERECTALSUPPOSITORYANDA040428b817fead-67a4-7b32-f791-f539132549b7
7458020758ANDAPerrigo New York Inc2006-06-27PROMETHAZINE HYDROCHLORIDERECTALSUPPOSITORYANDA040500047b9a7c-586b-4635-a63e-2c7ce9ec34e7
8516725296ANDATaro Pharmaceuticals U.S.A., Inc.2015-06-01PROMETHAZINE HYDROCHLORIDERECTALSUPPOSITORYANDA0404281240d030-9856-4a92-976a-d443507c743a

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548684794ANDAPhysicians Total Care, Inc.2003-05-20PROMETHAZINE HYDROCHLORIDERECTALSUPPOSITORY516721319ANDA0406036ad2e46c-c76b-4ca3-bfc7-9f903515b1b4
2552890940PhenadozANDAPd-Rx Pharmaceuticals, Inc.2003-06-24PROMETHAZINE HYDROCHLORIDERECTALSUPPOSITORY005747236ANDA0404793bed818a-e9a5-4a9c-bf5d-92ef717f5196

promethazine hydrochloride 25 mg rectal suppository

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005747234PhenadozANDAPaddock Laboratories, Llc2003-06-24PROMETHAZINE HYDROCHLORIDERECTALSUPPOSITORYANDA0404799aa7b3f2-4429-4a61-ad8e-876afb14cc45
2005912161PhenadozANDAWatson Laboratories, Inc.2013-04-03PROMETHAZINE HYDROCHLORIDERECTALSUPPOSITORYANDA040479c293895b-1010-4283-9228-1184f01a0ef0
3005912992PhenadozANDAWatson Laboratories, Inc.2015-02-17PROMETHAZINE HYDROCHLORIDERECTALSUPPOSITORYANDA040428e3cbbde7-2822-4d4c-bed7-36cf90df1715
4007130526PrometheganANDAG&W Laboratories, Inc.2002-02-28PROMETHAZINE HYDROCHLORIDERECTALSUPPOSITORYANDA0404285f079815-f48b-8b21-2130-7f791d967c9a
5400760319PhenerganANDAPrestium Pharma, Inc.2014-08-01PROMETHAZINE HYDROCHLORIDERECTALSUPPOSITORYANDA0404281fb782f2-37e3-0803-e2da-12a7c5b7bde2
6400850219ANDARenaissance Pharma, Inc.2014-08-01PROMETHAZINE HYDROCHLORIDERECTALSUPPOSITORYANDA040428b817fead-67a4-7b32-f791-f539132549b7
7458020759ANDAPerrigo New York Inc2006-05-17PROMETHAZINE HYDROCHLORIDERECTALSUPPOSITORYANDA040500047b9a7c-586b-4635-a63e-2c7ce9ec34e7
8516725297ANDATaro Pharmaceuticals U.S.A., Inc.2015-06-01PROMETHAZINE HYDROCHLORIDERECTALSUPPOSITORYANDA0404281240d030-9856-4a92-976a-d443507c743a

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1216950649ANDARebel Distributors Corp2003-06-30PROMETHAZINE HYDROCHLORIDERECTALSUPPOSITORY458020759ANDA0405003087a1cb-fda5-4115-86b6-1cce480a2f8e
2216950959PrometheganANDARebel Distributors Corp2002-02-05PROMETHAZINE HYDROCHLORIDERECTALSUPPOSITORY007130526ANDA040428c809171c-d424-4a17-a98d-f280a892b410
3430630060ANDAPd-Rx Pharmaceuticals, Inc.2006-05-17PROMETHAZINE HYDROCHLORIDERECTALSUPPOSITORY458020759ANDA0405007d766cf7-a21c-4eaf-bbdc-00f2939ef19a
4493490878PhenadozANDARemedyrepack Inc.2013-05-14PROMETHAZINE HYDROCHLORIDERECTALSUPPOSITORY005747234ANDA040479a4c676a8-def9-4498-bc39-3725df2c0802
5521250637PrometheganANDARemedyrepack Inc.2013-06-04PROMETHAZINE HYDROCHLORIDERECTALSUPPOSITORY007130526ANDA040428bf9d28d7-0ce1-48bb-85e8-48676e35069c
6529590731PrometheganANDAH.J. Harkins Company, Inc.2002-02-28PROMETHAZINE HYDROCHLORIDERECTALSUPPOSITORY007130526ANDA04042880a7fabd-20c1-40fa-878e-7e62983dbc89
7548680601ANDAPhysicians Total Care, Inc.2003-02-18PROMETHAZINE HYDROCHLORIDERECTALSUPPOSITORY516721320ANDA0406036ad2e46c-c76b-4ca3-bfc7-9f903515b1b4
8552890928PrometheganANDAPd-Rx Pharmaceuticals, Inc.2002-02-28PROMETHAZINE HYDROCHLORIDERECTALSUPPOSITORY007130526ANDA0404286b72dcf9-a4a1-4cc1-b7c2-a0bc2740fe97

promethazine hydrochloride 50 mg rectal suppository

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1007130132PrometheganANDAG&W Laboratories, Inc.1987-08-31PROMETHAZINE HYDROCHLORIDERECTALSUPPOSITORYANDA087165636bb9bc-0cc5-4d6a-85be-6471acf01ffc
2400760320PhenerganANDAPrestium Pharma, Inc.2014-08-01PROMETHAZINE HYDROCHLORIDERECTALSUPPOSITORYANDA087165d24e400d-e781-a0a4-b629-e99c32736b8a
3400850220ANDARenaissance Pharma, Inc.2014-08-01PROMETHAZINE HYDROCHLORIDERECTALSUPPOSITORYANDA0871658ddc3943-f815-ef61-ca5c-297104ed02a6

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548681613PrometheganANDAPhysicians Total Care, Inc.1996-06-17PROMETHAZINE HYDROCHLORIDERECTALSUPPOSITORY007130132ANDA087165b8a7573c-e8e0-4b33-ac8c-da9a8fe948c8

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA040428PROMETHAZINE HYDROCHLORIDEG AND W LABORATORIES INC2002-02-05ANDA040428_001, ANDA040428_002
2ANDA040449PROMETHAZINE HYDROCHLORIDETrueABLE LABORATORIES INC2003-02-27ANDA040449_001
3ANDA040479PROMETHAZINE HYDROCHLORIDEWATSON LABORATORIES INC2003-06-24ANDA040479_001, ANDA040479_002
4ANDA040500PROMETHAZINE HYDROCHLORIDEPERRIGO NEW YORK INC2003-06-30ANDA040500_001, ANDA040500_002
5ANDA040504PROMETHAZINE HYDROCHLORIDETrueABLE LABORATORIES INC2003-04-11ANDA040504_001, ANDA040504_002
6ANDA040603PROMETHAZINE HYDROCHLORIDETARO PHARMACEUTICALS USA INC2006-10-26ANDA040603_001, ANDA040603_002
7ANDA084901PROMETHACONTruePOLYMEDICA INDUSTRIES INCANDA084901_001
8ANDA084902PROMETHACONTruePOLYMEDICA INDUSTRIES INCANDA084902_001
9ANDA087165PROMETHEGANG AND W LABORATORIES INC1987-08-14ANDA087165_001
10NDA010926PHENERGANTrueDELCOR ASSET CORPNDA010926_001, NDA010926_002
11NDA011689PHENERGANTrueDELCOR ASSET CORPNDA011689_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA040428_001RXPROMETHAZINE HYDROCHLORIDE (25MG)RECTALSUPPOSITORYTrueAB2002-02-05PROMETHAZINE HYDROCHLORIDE
2ANDA040428_002RXPROMETHAZINE HYDROCHLORIDE (12.5MG)RECTALSUPPOSITORYFalseAB2003-03-31PROMETHAZINE HYDROCHLORIDE
3ANDA040449_001discontinuedPROMETHAZINE HYDROCHLORIDE (50MG)RECTALSUPPOSITORYFalse2003-02-27PROMETHAZINE HYDROCHLORIDE
4ANDA040479_001RXPROMETHAZINE HYDROCHLORIDE (12.5MG)RECTALSUPPOSITORYFalseAB2003-06-24PROMETHAZINE HYDROCHLORIDE
5ANDA040479_002RXPROMETHAZINE HYDROCHLORIDE (25MG)RECTALSUPPOSITORYFalseAB2003-06-24PROMETHAZINE HYDROCHLORIDE
6ANDA040500_001RXPROMETHAZINE HYDROCHLORIDE (12.5MG)RECTALSUPPOSITORYFalseAB2003-06-30PROMETHAZINE HYDROCHLORIDE
7ANDA040500_002RXPROMETHAZINE HYDROCHLORIDE (25MG)RECTALSUPPOSITORYFalseAB2003-06-30PROMETHAZINE HYDROCHLORIDE
8ANDA040504_001discontinuedPROMETHAZINE HYDROCHLORIDE (12.5MG)RECTALSUPPOSITORYFalse2003-04-11PROMETHAZINE HYDROCHLORIDE
9ANDA040504_002discontinuedPROMETHAZINE HYDROCHLORIDE (25MG)RECTALSUPPOSITORYFalse2003-04-11PROMETHAZINE HYDROCHLORIDE
10ANDA040603_001RXPROMETHAZINE HYDROCHLORIDE (12.5MG)RECTALSUPPOSITORYFalseAB2006-10-26PROMETHAZINE HYDROCHLORIDE
11ANDA040603_002RXPROMETHAZINE HYDROCHLORIDE (25MG)RECTALSUPPOSITORYFalseAB2006-10-26PROMETHAZINE HYDROCHLORIDE
12ANDA084901_001discontinuedPROMETHAZINE HYDROCHLORIDE (25MG)RECTALSUPPOSITORYFalsePROMETHACON
13ANDA084902_001discontinuedPROMETHAZINE HYDROCHLORIDE (50MG)RECTALSUPPOSITORYFalsePROMETHACON
14ANDA087165_001RXPROMETHAZINE HYDROCHLORIDE (50MG)RECTALSUPPOSITORYTrue1987-08-14PROMETHEGAN
15NDA010926_001discontinuedPROMETHAZINE HYDROCHLORIDE (25MG)RECTALSUPPOSITORYFalsePHENERGAN
16NDA010926_002discontinuedPROMETHAZINE HYDROCHLORIDE (12.5MG)RECTALSUPPOSITORYFalsePHENERGAN
17NDA011689_001discontinuedPROMETHAZINE HYDROCHLORIDE (50MG)RECTALSUPPOSITORYFalsePHENERGAN

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1047b9a7c-586b-4635-a63e-2c7ce9ec34e7 (view SPL)Promethazine Hydrochloride Suppositories USP,12.5 mg and 25 mgprescriptionHuman PrescriptionPerrigo New York Inc2015-04-285458020758, 458020759
21240d030-9856-4a92-976a-d443507c743a (view SPL)PROMETHAZINE HYDROCHLORIDE SUPPOSITORIES, USPprescriptionHuman PrescriptionTaro Pharmaceuticals U.S.A., Inc.MANUFACTURE2015-05-221516725296, 516725297
31fb782f2-37e3-0803-e2da-12a7c5b7bde2 (view SPL)PHENERGAN(PROMETHAZINE HYDROCHLORIDE)SUPPOSITORIES, USP Rx OnlyprescriptionHuman PrescriptionPrestium Pharma, Inc.MANUFACTURE2014-06-232400760318, 400760319
43087a1cb-fda5-4115-86b6-1cce480a2f8e (view SPL)Promethazine Hydrochloride Suppositories, USP25 mgprescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2010-11-111216950649
53bed818a-e9a5-4a9c-bf5d-92ef717f5196 (view SPL)PHENADOZ Promethazine HCl Suppositories USPprescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2009-08-114552890940
65f079815-f48b-8b21-2130-7f791d967c9a (view SPL)PROMETHAZINE HYDROCHLORIDESUPPOSITORIES, USP Rx OnlyprescriptionHuman PrescriptionG&W Laboratories, Inc.MANUFACTURE2014-06-242007130526, 007130536
7636bb9bc-0cc5-4d6a-85be-6471acf01ffc (view SPL)PROMETHAZINE HYDROCHLORIDESUPPOSITORIES, USP Rx OnlyprescriptionHuman PrescriptionG&W Laboratories, Inc.MANUFACTURE2014-06-243007130132
86ad2e46c-c76b-4ca3-bfc7-9f903515b1b4 (view SPL)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2010-08-101548680601, 548684794
96b72dcf9-a4a1-4cc1-b7c2-a0bc2740fe97 (view SPL)prescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2011-07-131552890928
107d766cf7-a21c-4eaf-bbdc-00f2939ef19a (view SPL)Promethazine Hydrochloride Suppositories USP,12.5 mg and 25 mgprescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2011-03-283430630060
1180a7fabd-20c1-40fa-878e-7e62983dbc89 (view SPL)prescriptionHuman PrescriptionH.J. Harkins Company, Inc.MANUFACTURE2012-03-092529590731
128ddc3943-f815-ef61-ca5c-297104ed02a6 (view SPL)PROMETHAZINE HYDROCHLORIDESUPPOSITORIES, USP Rx OnlyprescriptionHuman PrescriptionRenaissance Pharma, Inc.MANUFACTURE2014-06-253400850220
139aa7b3f2-4429-4a61-ad8e-876afb14cc45 (view SPL)PHENADOZ Promethazine HCl Suppositories USPprescriptionHuman PrescriptionPaddock Laboratories, LlcMANUFACTURE2009-08-114005747234, 005747236
14a4c676a8-def9-4498-bc39-3725df2c0802 (view SPL)PHENADOZPromethazine HCl Suppositories USPprescriptionHuman PrescriptionRemedyrepack Inc.2013-05-141493490878
15b817fead-67a4-7b32-f791-f539132549b7 (view SPL)PROMETHAZINE HYDROCHLORIDESUPPOSITORIES, USP Rx OnlyprescriptionHuman PrescriptionRenaissance Pharma, Inc.MANUFACTURE2014-06-243400850218, 400850219
16b8a7573c-e8e0-4b33-ac8c-da9a8fe948c8 (view SPL)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2012-11-053548681613
17bf9d28d7-0ce1-48bb-85e8-48676e35069c (view SPL)prescriptionHuman PrescriptionRemedyrepack Inc.2013-06-041521250637
18c293895b-1010-4283-9228-1184f01a0ef0 (view SPL)PHENADOZ Promethazine HCl Suppositories USP Rx OnlyprescriptionHuman PrescriptionWatson Laboratories, Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2013-12-044005912160, 005912161
19c809171c-d424-4a17-a98d-f280a892b410 (view SPL)PROMETHAZINE HYDROCHLORIDEprescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2011-09-131216950959
20d24e400d-e781-a0a4-b629-e99c32736b8a (view SPL)PHENERGAN(PROMETHAZINE HYDROCHLORIDE)SUPPOSITORIES, USP Rx OnlyprescriptionHuman PrescriptionPrestium Pharma, Inc.MANUFACTURE2014-06-232400760320
21e3cbbde7-2822-4d4c-bed7-36cf90df1715 (view SPL)PHENADOZ PROMETHAZINEHClSUPPOSITORIES, USP Rx OnlyprescriptionHuman PrescriptionWatson Laboratories, Inc.2014-06-012005912985, 005912992

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