Oxycodone Oral Capsule

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Lehigh Valley Technologies, Inc. (2010-11-18)
Oldest Current Product
2010-03-08
License(s)
NDA, NDA AUTHORIZED GENERIC, ANDA
RxNORM
ORAL CAPSULE\OXYCODONE
FDAOB
ORAL\CAPSULE\OXYCODONE HYDROCHLORIDE
ORAL\TABLET\OXYCODONE HYDROCHLORIDE
SPL Active
ORAL\CAPSULE\OXYCODONE HYDROCHLORIDE
SPL Moiety
ORAL\CAPSULE\OXYCODONE

product(s) by strength(s)

oxycodone hydrochloride 5 mg oral capsule

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1649500901NDALehigh Valley Technologies, Inc.2010-10-20OXYCODONE HYDROCHLORIDEORALCAPSULENDA200534061cf52b-4432-422d-a97b-c3e1f8c4bab6

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005271774ANDALannett Company, Inc.2014-08-01OXYCODONE HYDROCHLORIDEORALCAPSULEANDA2038236eaff86d-3b90-499e-b46f-316a35f5d811
2107020023ANDAKvk-Tech, Inc.2015-08-20OXYCODONE HYDROCHLORIDEORALCAPSULEANDA202773338b5391-e5f7-40a2-8b15-57f47cbc4813
3400320950ANDANovel Laboratories, Inc.2015-08-24OXYCODONE HYDROCHLORIDEORALCAPSULEANDA20475269410bf3-0d3a-41f9-b10a-c4ee3770f728
4683080145ANDAMayne Pharma Inc.2012-07-31OXYCODONE HYDROCHLORIDEORALCAPSULEANDA203107d57345c9-19cf-4d12-a7b1-e0c5f78d5198
5684620204NDA AUTHORIZED GENERICGlenmark Generics Inc., Usa2010-12-15OXYCODONE HYDROCHLORIDEORALCAPSULENDA200534566ef74d-5c0b-49bf-9619-e757d16431ef

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1606870116NDA AUTHORIZED GENERICAmerican Health Packaging2015-03-31OXYCODONE HYDROCHLORIDEORALCAPSULE684620204NDA200534edf94500-97e2-4782-8371-e1f12c78457f
2636293763NDA AUTHORIZED GENERICBryant Ranch Prepack2010-12-15OXYCODONE HYDROCHLORIDEORALCAPSULE684620204NDA200534162692a0-0274-46aa-a3a9-6cc14fe6e021
3636293803NDA AUTHORIZED GENERICBryant Ranch Prepack2010-12-15OXYCODONE HYDROCHLORIDEORALCAPSULE684620204NDA200534a22b4011-322d-4b61-9349-1b32e1f3a361
4636294155ANDABryant Ranch Prepack2010-03-08OXYCODONE HYDROCHLORIDEORALCAPSULE684620204ANDA0777129ee2fa21-b80d-449a-8e36-260cc79ef600

application(s)

#idtitleapplicantapprovedpatentapproved drugin other drug docs
1ANDA076636OXYCODONE HYDROCHLORIDEACTAVIS ELIZABETH LLC2004-02-06ANDA076636_001, ANDA076636_002, ANDA076636_003Oxycodone Oral Tablet
2ANDA076758OXYCODONE HYDROCHLORIDEMALLINCKRODT INC2004-06-30ANDA076758_001, ANDA076758_002, ANDA076758_003Oxycodone Oral Tablet
3ANDA077290OXYCODONE HYDROCHLORIDENESHER PHARMACEUTICALS USA LLC2005-12-08ANDA077290_001, ANDA077290_002, ANDA077290_003, ANDA077290_004, ANDA077290_005Oxycodone Oral Tablet
4ANDA077712OXYCODONE HYDROCHLORIDEVINTAGE PHARMACEUTICALS INC2007-01-31ANDA077712_001, ANDA077712_002, ANDA077712_003, ANDA077712_004, ANDA077712_005Oxycodone Oral Tablet
5ANDA090659OXYCODONE HYDROCHLORIDESUN PHARMACEUTICAL INDUSTRIES INC2009-04-10ANDA090659_001, ANDA090659_002, ANDA090659_003, ANDA090659_004, ANDA090659_005Oxycodone Oral Tablet
6ANDA090895OXYCODONE HYDROCHLORIDECOREPHARMA LLC2009-08-24ANDA090895_001, ANDA090895_002, ANDA090895_003Oxycodone Oral Tablet
7ANDA091313OXYCODONE HYDROCHLORIDECOASTAL PHARMACEUTICALS2011-02-18ANDA091313_001, ANDA091313_002, ANDA091313_003Oxycodone Oral Tablet
8ANDA091393OXYCODONE HYDROCHLORIDEAVANTHI INC2009-08-31ANDA091393_001, ANDA091393_002, ANDA091393_003, ANDA091393_004, ANDA091393_005Oxycodone Oral Tablet
9ANDA091490OXYCODONE HYDROCHLORIDERHODES PHARMACEUTICALS LP2011-03-09ANDA091490_001, ANDA091490_002, ANDA091490_003, ANDA091490_004, ANDA091490_005Oxycodone Oral Tablet
10ANDA202116OXYCODONE HYDROCHLORIDEALVOGEN INC2011-12-30ANDA202116_001, ANDA202116_002, ANDA202116_003Oxycodone Oral Tablet
11ANDA202160OXYCODONE HYDROCHLORIDEAUROLIFE PHARMA LLC2012-11-19ANDA202160_001, ANDA202160_002, ANDA202160_003Oxycodone Oral Tablet
12ANDA202662OXYCODONE HYDROCHLORIDEEPIC PHARMA LLC2015-09-22ANDA202662_001, ANDA202662_002, ANDA202662_003, ANDA202662_004Oxycodone Oral Tablet
13ANDA202773OXYCODONE HYDROCHLORIDEAVANTHI INC2015-08-17ANDA202773_001
14ANDA203107OXYCODONE HYDROCHLORIDECOASTAL PHARMACEUTICALS2012-07-26ANDA203107_001
15ANDA203638OXYCODONE HYDROCHLORIDEAMNEAL PHARMACEUTICALS2014-06-03ANDA203638_001, ANDA203638_002, ANDA203638_003, ANDA203638_004, ANDA203638_005Oxycodone Oral Tablet
16ANDA203823OXYCODONE HYDROCHLORIDELANNETT HOLDINGS INC2014-08-01ANDA203823_001
17ANDA204752OXYCODONE HYDROCHLORIDENOVEL LABORATORIES INC2015-08-24ANDA204752_001
18NDA021011ROXICODONEMALLINCKRODT INC2000-08-31NDA021011_001, NDA021011_002, NDA021011_003Oxycodone Oral Tablet
19NDA200534OXYCODONE HYDROCHLORIDELEHIGH VALLEY TECHNOLOGIES INC2010-10-20NDA200534_001
20NDA202080OXAYDOEGALET US INC2011-06-17p7201920, SUBSTANCE
p8409616, SUBSTANCE
p8637540, SUBSTANCE
p7510726, SUBSTANCE
p7981439, SUBSTANCE
NDA202080_001, NDA202080_002Oxycodone Oral Tablet

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA076636_001RXOXYCODONE HYDROCHLORIDE (15MG)ORALTABLETFalseAB2004-02-06OXYCODONE HYDROCHLORIDE
2ANDA076636_002RXOXYCODONE HYDROCHLORIDE (30MG)ORALTABLETFalseAB2004-02-06OXYCODONE HYDROCHLORIDE
3ANDA076636_003RXOXYCODONE HYDROCHLORIDE (5MG)ORALTABLETFalseAB2015-04-07OXYCODONE HYDROCHLORIDE
4ANDA076758_001RXOXYCODONE HYDROCHLORIDE (15MG)ORALTABLETFalseAB2004-06-30OXYCODONE HYDROCHLORIDE
5ANDA076758_002RXOXYCODONE HYDROCHLORIDE (30MG)ORALTABLETFalseAB2004-06-30OXYCODONE HYDROCHLORIDE
6ANDA076758_003RXOXYCODONE HYDROCHLORIDE (5MG)ORALTABLETFalseAB2007-03-19OXYCODONE HYDROCHLORIDE
7ANDA077290_001RXOXYCODONE HYDROCHLORIDE (5MG)ORALTABLETFalseAB2005-12-08OXYCODONE HYDROCHLORIDE
8ANDA077290_002RXOXYCODONE HYDROCHLORIDE (10MG)ORALTABLETFalseAB2005-12-08OXYCODONE HYDROCHLORIDE
9ANDA077290_003RXOXYCODONE HYDROCHLORIDE (15MG)ORALTABLETFalseAB2005-12-08OXYCODONE HYDROCHLORIDE
10ANDA077290_004RXOXYCODONE HYDROCHLORIDE (20MG)ORALTABLETFalseAB2005-12-08OXYCODONE HYDROCHLORIDE
11ANDA077290_005RXOXYCODONE HYDROCHLORIDE (30MG)ORALTABLETFalseAB2005-12-08OXYCODONE HYDROCHLORIDE
12ANDA077712_001RXOXYCODONE HYDROCHLORIDE (15MG)ORALTABLETFalseAB2007-01-31OXYCODONE HYDROCHLORIDE
13ANDA077712_002RXOXYCODONE HYDROCHLORIDE (30MG)ORALTABLETFalseAB2007-01-31OXYCODONE HYDROCHLORIDE
14ANDA077712_003RXOXYCODONE HYDROCHLORIDE (5MG)ORALTABLETFalseAB2009-03-02OXYCODONE HYDROCHLORIDE
15ANDA077712_004RXOXYCODONE HYDROCHLORIDE (10MG)ORALTABLETFalseAB2015-04-13OXYCODONE HYDROCHLORIDE
16ANDA077712_005RXOXYCODONE HYDROCHLORIDE (20MG)ORALTABLETFalseAB2015-04-13OXYCODONE HYDROCHLORIDE
17ANDA090659_001RXOXYCODONE HYDROCHLORIDE (5MG)ORALTABLETFalseAB2009-04-10OXYCODONE HYDROCHLORIDE
18ANDA090659_002RXOXYCODONE HYDROCHLORIDE (15MG)ORALTABLETFalseAB2009-04-10OXYCODONE HYDROCHLORIDE
19ANDA090659_003RXOXYCODONE HYDROCHLORIDE (30MG)ORALTABLETFalseAB2009-04-10OXYCODONE HYDROCHLORIDE
20ANDA090659_004RXOXYCODONE HYDROCHLORIDE (20MG)ORALTABLETFalseAB2012-11-06OXYCODONE HYDROCHLORIDE
21ANDA090659_005RXOXYCODONE HYDROCHLORIDE (10MG)ORALTABLETFalseAB2012-11-06OXYCODONE HYDROCHLORIDE
22ANDA090895_001RXOXYCODONE HYDROCHLORIDE (5MG)ORALTABLETFalseAB2009-08-24OXYCODONE HYDROCHLORIDE
23ANDA090895_002RXOXYCODONE HYDROCHLORIDE (15MG)ORALTABLETFalseAB2009-08-24OXYCODONE HYDROCHLORIDE
24ANDA090895_003RXOXYCODONE HYDROCHLORIDE (30MG)ORALTABLETFalseAB2009-08-24OXYCODONE HYDROCHLORIDE
25ANDA091313_001RXOXYCODONE HYDROCHLORIDE (5MG)ORALTABLETFalseAB2011-02-18OXYCODONE HYDROCHLORIDE
26ANDA091313_002RXOXYCODONE HYDROCHLORIDE (15MG)ORALTABLETFalseAB2011-02-18OXYCODONE HYDROCHLORIDE
27ANDA091313_003RXOXYCODONE HYDROCHLORIDE (30MG)ORALTABLETFalseAB2011-02-18OXYCODONE HYDROCHLORIDE
28ANDA091393_001RXOXYCODONE HYDROCHLORIDE (5MG)ORALTABLETFalseAB2009-08-31OXYCODONE HYDROCHLORIDE
29ANDA091393_002RXOXYCODONE HYDROCHLORIDE (10MG)ORALTABLETFalseAB2009-08-31OXYCODONE HYDROCHLORIDE
30ANDA091393_003RXOXYCODONE HYDROCHLORIDE (15MG)ORALTABLETFalseAB2009-08-31OXYCODONE HYDROCHLORIDE
31ANDA091393_004RXOXYCODONE HYDROCHLORIDE (20MG)ORALTABLETFalseAB2009-08-31OXYCODONE HYDROCHLORIDE
32ANDA091393_005RXOXYCODONE HYDROCHLORIDE (30MG)ORALTABLETFalseAB2009-08-31OXYCODONE HYDROCHLORIDE
33ANDA091490_001RXOXYCODONE HYDROCHLORIDE (5MG)ORALTABLETFalseAB2011-03-09OXYCODONE HYDROCHLORIDE
34ANDA091490_002RXOXYCODONE HYDROCHLORIDE (10MG)ORALTABLETFalseAB2011-03-09OXYCODONE HYDROCHLORIDE
35ANDA091490_003RXOXYCODONE HYDROCHLORIDE (15MG)ORALTABLETFalseAB2011-03-09OXYCODONE HYDROCHLORIDE
36ANDA091490_004RXOXYCODONE HYDROCHLORIDE (20MG)ORALTABLETFalseAB2011-03-09OXYCODONE HYDROCHLORIDE
37ANDA091490_005RXOXYCODONE HYDROCHLORIDE (30MG)ORALTABLETFalseAB2011-03-09OXYCODONE HYDROCHLORIDE
38ANDA202116_001RXOXYCODONE HYDROCHLORIDE (5MG)ORALTABLETFalseAB2011-12-30OXYCODONE HYDROCHLORIDE
39ANDA202116_002RXOXYCODONE HYDROCHLORIDE (15MG)ORALTABLETFalseAB2011-12-30OXYCODONE HYDROCHLORIDE
40ANDA202116_003RXOXYCODONE HYDROCHLORIDE (30MG)ORALTABLETFalseAB2011-12-30OXYCODONE HYDROCHLORIDE
41ANDA202160_001RXOXYCODONE HYDROCHLORIDE (5MG)ORALTABLETFalseAB2012-11-19OXYCODONE HYDROCHLORIDE
42ANDA202160_002RXOXYCODONE HYDROCHLORIDE (15MG)ORALTABLETFalseAB2012-11-19OXYCODONE HYDROCHLORIDE
43ANDA202160_003RXOXYCODONE HYDROCHLORIDE (30MG)ORALTABLETFalseAB2012-11-19OXYCODONE HYDROCHLORIDE
44ANDA202662_001RXOXYCODONE HYDROCHLORIDE (5MG)ORALTABLETFalseAB2015-09-22OXYCODONE HYDROCHLORIDE
45ANDA202662_002RXOXYCODONE HYDROCHLORIDE (10MG)ORALTABLETFalseAB2015-09-22OXYCODONE HYDROCHLORIDE
46ANDA202662_003RXOXYCODONE HYDROCHLORIDE (15MG)ORALTABLETFalseAB2015-09-22OXYCODONE HYDROCHLORIDE
47ANDA202662_004RXOXYCODONE HYDROCHLORIDE (30MG)ORALTABLETFalseAB2015-09-22OXYCODONE HYDROCHLORIDE
48ANDA202773_001RXOXYCODONE HYDROCHLORIDE (5MG)ORALCAPSULEFalseAB2015-08-17OXYCODONE HYDROCHLORIDE
49ANDA203107_001RXOXYCODONE HYDROCHLORIDE (5MG)ORALCAPSULEFalseAB2012-07-26OXYCODONE HYDROCHLORIDE
50ANDA203638_001RXOXYCODONE HYDROCHLORIDE (5MG)ORALTABLETFalseAB2014-06-03OXYCODONE HYDROCHLORIDE
51ANDA203638_002RXOXYCODONE HYDROCHLORIDE (10MG)ORALTABLETFalseAB2014-06-03OXYCODONE HYDROCHLORIDE
52ANDA203638_003RXOXYCODONE HYDROCHLORIDE (15MG)ORALTABLETFalseAB2014-06-03OXYCODONE HYDROCHLORIDE
53ANDA203638_004RXOXYCODONE HYDROCHLORIDE (20MG)ORALTABLETFalseAB2014-06-03OXYCODONE HYDROCHLORIDE
54ANDA203638_005RXOXYCODONE HYDROCHLORIDE (30MG)ORALTABLETFalseAB2014-06-03OXYCODONE HYDROCHLORIDE
55ANDA203823_001RXOXYCODONE HYDROCHLORIDE (5MG)ORALCAPSULEFalseAB2014-08-01OXYCODONE HYDROCHLORIDE
56ANDA204752_001RXOXYCODONE HYDROCHLORIDE (5MG)ORALCAPSULEFalseAB2015-08-24OXYCODONE HYDROCHLORIDE
57NDA021011_001RXOXYCODONE HYDROCHLORIDE (15MG)ORALTABLETTrueAB2000-08-31ROXICODONE
58NDA021011_002RXOXYCODONE HYDROCHLORIDE (30MG)ORALTABLETFalseAB2000-08-31ROXICODONE
59NDA021011_003RXOXYCODONE HYDROCHLORIDE (5MG)ORALTABLETFalseAB2009-05-15ROXICODONE
60NDA200534_001RXOXYCODONE HYDROCHLORIDE (5MG)ORALCAPSULETrueAB2010-10-20OXYCODONE HYDROCHLORIDE
61NDA202080_001RXOXYCODONE HYDROCHLORIDE (5MG)ORALTABLETFalse2011-06-17OXAYDO
62NDA202080_002RXOXYCODONE HYDROCHLORIDE (7.5MG)ORALTABLETFalse2011-06-17OXAYDO

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p7201920 (view patent)2025-03-16NDA202080Oxycodone Oral Tablet
2p7510726 (view patent)2023-11-26NDA202080Oxycodone Oral Tablet
3p7981439 (view patent)2023-11-26NDA202080Oxycodone Oral Tablet
4p8409616 (view patent)2023-11-26NDA202080Oxycodone Oral Tablet
5p8637540 (view patent)2023-11-26NDA202080Oxycodone Oral Tablet

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1061cf52b-4432-422d-a97b-c3e1f8c4bab6 (view SPL)These highlights do not include all the information needed to use Oxycodone Hydrochloride Capsules safely and effectively. See full prescribing information for Oxycodone Hydrochloride Capsules. Oxycodone Hydrochloride Capsules CIIInitial U.S. Approval: 1950prescriptionHuman PrescriptionLehigh Valley Technologies, Inc.manufacture2010-11-183649500901
2162692a0-0274-46aa-a3a9-6cc14fe6e021 (view SPL)These highlights do not include all the information needed to use Oxycodone Hydrochloride Capsules safely and effectively. See full prescribing information for Oxycodone Hydrochloride Capsules. Oxycodone Hydrochloride Capsules CII Initial U.S. Approval: 1950prescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2015-04-281000636293763
3338b5391-e5f7-40a2-8b15-57f47cbc4813 (view SPL)These highlights do not include all the information needed to use Oxycodone Hydrochloride Capsules safely and effectively. See full prescribing information for Oxycodone Hydrochloride Capsules. OXYCODONEHydrochloride Capsules, for oral use CII Initial U.S. Approval: 1950prescriptionHuman PrescriptionKvk-Tech, Inc.MANUFACTURE2015-09-283107020023
4566ef74d-5c0b-49bf-9619-e757d16431ef (view SPL)These highlights do not include all the information needed to use Oxycodone Hydrochloride Capsules safely and effectively. See full prescribing information for Oxycodone Hydrochloride Capsules. Oxycodone Hydrochloride Capsules CII Initial U.S. Approval: 1950prescriptionHuman PrescriptionGlenmark Generics Inc., Usa2011-01-112684620204
569410bf3-0d3a-41f9-b10a-c4ee3770f728 (view SPL)These highlights do not include all the information needed to use Oxycodone Hydrochloride safely and effectively. See full prescribing information for Oxycodone Hydrochloride. Oxycodone Hydrochloride (Oxycodone Hydrochloride) CAPSULE for ORAL use.Initial U.S. Approval: 1950prescriptionHuman PrescriptionNovel Laboratories, Inc.ANALYSIS, MANUFACTURE2014-10-142400320950
66eaff86d-3b90-499e-b46f-316a35f5d811 (view SPL)These highlights do not include all the information needed to useoxycodone hydrochloride capsulessafely and effectively. See full prescribing information for oxycodone hydrochloride capsules. Oxycodone Hydrochloride Capsules CIIInitial U.S. Approval: 1950prescriptionHuman PrescriptionLannett Company, Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2014-08-0617005271774
79ee2fa21-b80d-449a-8e36-260cc79ef600 (view SPL)oxycodone hydrochloride 5mg CapsuleprescriptionHuman PrescriptionBryant Ranch Prepackrepack2010-03-082636294155
8a22b4011-322d-4b61-9349-1b32e1f3a361 (view SPL)These highlights do not include all the information needed to use Oxycodone Hydrochloride Capsules safely and effectively. See full prescribing information for Oxycodone Hydrochloride Capsules. Oxycodone Hydrochloride Capsules CII Initial U.S. Approval: 1950prescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2013-01-181000636293803
9d57345c9-19cf-4d12-a7b1-e0c5f78d5198 (view SPL)These highlights do not include all the information needed to use oxycodone hydrochloride capsules safely and effectively. See full prescribing information for oxycodone hydrochloride capsules. OXYCODONE HYDROCHLORIDE CAPSULES, CII Initial U.S. Approval: 1950prescriptionHuman PrescriptionMayne Pharma Inc.MANUFACTURE2012-08-066683080145
10edf94500-97e2-4782-8371-e1f12c78457f (view SPL)These highlights do not include all the information needed to use Oxycodone Hydrochloride Capsules safely and effectively. See full prescribing information for Oxycodone Hydrochloride Capsules. Oxycodone Hydrochloride Capsules CIIInitial U.S. Approval: 1950prescriptionHuman PrescriptionAmerican Health PackagingREPACK2015-03-061606870116

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