Application 202991

Type: ANDA
Sponsor: RHODES PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	ACETAMINOPHEN; HYDROCODONE BITARTRATE	TABLET;ORAL	325MG;5MG	No	No
002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	ACETAMINOPHEN; HYDROCODONE BITARTRATE	TABLET;ORAL	325MG;7.5MG	No	No
003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	ACETAMINOPHEN; HYDROCODONE BITARTRATE	TABLET;ORAL	325MG;10MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A202991-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	ACETAMINOPHEN; HYDROCODONE BITARTRATE	325MG;5MG	TABLET / ORAL	AA	2016-04-12
A202991-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	ACETAMINOPHEN; HYDROCODONE BITARTRATE	325MG;7.5MG	TABLET / ORAL	AA	2016-04-12
A202991-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	ACETAMINOPHEN; HYDROCODONE BITARTRATE	325MG;10MG	TABLET / ORAL	AA	2016-04-12

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A202991-001	AA
A202991-002	AA
A202991-003	AA

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A202991-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2016-04-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202991-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2016-04-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202991-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2016-04-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202991-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2016-04-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202991-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2016-04-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202991-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2016-04-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202991-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2016-04-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202991-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2016-04-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202991-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2016-04-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202991-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2016-04-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202991-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2016-04-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202991-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2016-04-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202991-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2016-04-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202991-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2016-04-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202991-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2016-04-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202991-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2016-04-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202991-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2016-04-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202991-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2016-04-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202991-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2016-04-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202991-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2016-04-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202991-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2016-04-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202991-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2016-04-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202991-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2016-04-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202991-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2016-04-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202991-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2016-04-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202991-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2016-04-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202991-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2016-04-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202991-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2016-04-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202991-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2016-04-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202991-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2016-04-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202991-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2016-04-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202991-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2016-04-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202991-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2016-04-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202991-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2016-04-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202991-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2016-04-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202991-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2016-04-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202991-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2016-04-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202991-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2016-04-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202991-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2016-04-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202991-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2016-04-12	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A202991-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202991-002	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202991-003	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202991-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202991-002	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202991-003	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202991-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202991-002	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202991-003	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202991-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202991-002	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202991-003	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202991-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202991-002	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202991-003	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202991-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202991-002	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202991-003	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202991-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202991-002	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202991-003	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202991-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202991-002	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202991-003	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202991-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202991-002	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202991-003	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202991-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202991-002	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202991-003	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202991-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202991-002	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202991-003	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202991-001	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202991-002	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202991-003	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202991-001	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202991-002	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202991-003	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202991-001	AA	1	`8072bd15b7f6…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 19 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydrocodone Bitartrate and Acetaminophen	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	Bryant Ranch Prepack	8ad0df84-e3f6-4c1d-b791-c8467eb984aa	2026-06-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202991 application number: ANDA202991 ndc (product): 71335-1419
Hydrocodone Bitartrate and Acetaminophen	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	Bryant Ranch Prepack	418ea599-55e0-4d57-a4b1-16568e30f6f7	2026-06-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202991 application number: ANDA202991 ndc (product): 71335-1444
Hydrocodone Bitartrate and Acetaminophen	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	Bryant Ranch Prepack	25d49886-9f9a-4015-bca2-9190b30d9120	2026-06-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202991 application number: ANDA202991 ndc (product): 71335-1470
Hydrocodone Bitartrate and Acetaminophen	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	Bryant Ranch Prepack	e83d90f9-513b-47c2-ae2a-748ce775ef5d	2026-06-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202991 application number: ANDA202991 ndc (product): 71335-1418
Hydrocodone Bitartrate and Acetaminophen	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	Bryant Ranch Prepack	380ff458-d5d7-422e-ac96-e9a56ade16b6	2026-06-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202991 application number: ANDA202991 ndc (product): 63629-8499
Hydrocodone Bitartrate and Acetaminophen	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	Rhodes Pharmaceuticals LLC	1f9c1adc-f84f-43de-af5c-d93703aba7f8	2026-05-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202991 application number: ANDA202991 ndc (product): 42858-201 ndc (product): 42858-203 ndc (product): 42858-202
Hydrocodone Bitartrate and Acetaminophen	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	Bryant Ranch Prepack	44687e20-a1c4-4cf3-b2ac-4d489d54b740	2026-05-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202991 application number: ANDA202991 ndc (product): 63629-2468
Hydrocodone Bitartrate and Acetaminophen	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	Bryant Ranch Prepack	3d431951-eb0f-45ac-a6ba-d99929bdcaaf	2026-05-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202991 application number: ANDA202991 ndc (product): 63629-2470
Hydrocodone Bitartrate and Acetaminophen	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	Bryant Ranch Prepack	878c004c-1e92-4400-95f5-e79cf9ba6844	2026-05-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202991 application number: ANDA202991 ndc (product): 63629-2471
Hydrocodone Bitartrate and Acetaminophen	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	Bryant Ranch Prepack	a8b9e9fe-e1a5-4a77-9a1f-d30eb622168c	2026-05-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202991 application number: ANDA202991 ndc (product): 71335-1811
Hydrocodone Bitartrate and Acetaminophen	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	Bryant Ranch Prepack	0cc8836b-f0af-42e0-bd77-53fd1dd1aca7	2026-05-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202991 application number: ANDA202991 ndc (product): 71335-1557
Hydrocodone Bitartrate and Acetaminophen	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	Bryant Ranch Prepack	3bd8e7b1-e31c-4298-ba1e-eaf2a0954208	2026-04-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202991 application number: ANDA202991
Hydrocodone Bitartrate and Acetaminophen	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	Bryant Ranch Prepack	a2e33ea3-941f-4810-b008-abbb109730a9	2026-04-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202991 application number: ANDA202991
Hydrocodone Bitartrate and Acetaminophen	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	Bryant Ranch Prepack	29491adb-d95d-4f68-ac01-61bad73e08fc	2026-03-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202991 application number: ANDA202991
Hydrocodone Bitartrate and Acetaminophen	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	Asclemed USA, Inc.	d1de0f93-1439-4ee3-b692-56e1a1400682	2025-11-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202991 application number: ANDA202991 ndc (product): 76420-133
Hydrocodone Bitartrate and Acetaminophen	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	Bryant Ranch Prepack	82b7fd34-02ac-434a-be38-a1f0ec4f3e50	2024-08-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202991 application number: ANDA202991 ndc (product): 71335-1417
Hydrocodone Bitartrate and Acetaminophen	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	Bryant Ranch Prepack	025eb0f7-d002-4ce0-87b8-71461ab18356	2024-08-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202991 application number: ANDA202991 ndc (product): 63629-2469
Hydrocodone Bitartrate and Acetaminophen	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	Asclemed USA, Inc.	23dde6b8-3655-49ee-ac2c-28f80cf6b3c2	2022-07-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202991 application number: ANDA202991 ndc (product): 76420-257
Hydrocodone Bitartrate and Acetaminophen	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	Asclemed USA, Inc.	5c00f98f-dcab-4bdb-901e-02eb873dea31	2022-05-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202991 application number: ANDA202991 ndc (product): 76420-215

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 59 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42858-201	Hydrocodone Bitartrate and Acetaminophen	Hydrocodone Bitartrate and Acetaminophen	Rhodes Pharmaceuticals L.P.	ANDA	Current
42858-201	Hydrocodone Bitartrate and Acetaminophen	Hydrocodone Bitartrate and Acetaminophen	Rhodes Pharmaceuticals L.P.	ANDA	Current
42858-201	Hydrocodone Bitartrate and Acetaminophen	Hydrocodone Bitartrate and Acetaminophen	Rhodes Pharmaceuticals L.P.	ANDA	Current
42858-202	Hydrocodone Bitartrate and Acetaminophen	Hydrocodone Bitartrate and Acetaminophen	Rhodes Pharmaceuticals L.P.	ANDA	Current
42858-202	Hydrocodone Bitartrate and Acetaminophen	Hydrocodone Bitartrate and Acetaminophen	Rhodes Pharmaceuticals L.P.	ANDA	Current
42858-202	Hydrocodone Bitartrate and Acetaminophen	Hydrocodone Bitartrate and Acetaminophen	Rhodes Pharmaceuticals L.P.	ANDA	Current
42858-203	Hydrocodone Bitartrate and Acetaminophen	Hydrocodone Bitartrate and Acetaminophen	Rhodes Pharmaceuticals L.P.	ANDA	Current
42858-203	Hydrocodone Bitartrate and Acetaminophen	Hydrocodone Bitartrate and Acetaminophen	Rhodes Pharmaceuticals L.P.	ANDA	Current
42858-203	Hydrocodone Bitartrate and Acetaminophen	Hydrocodone Bitartrate and Acetaminophen	Rhodes Pharmaceuticals L.P.	ANDA	Current
50090-4065	Hydrocodone Bitartrate and Acetaminophen	Hydrocodone Bitartrate and Acetaminophen	A-S Medication Solutions	ANDA	Current
50090-4065	Hydrocodone Bitartrate and Acetaminophen	Hydrocodone Bitartrate and Acetaminophen	A-S Medication Solutions	ANDA	Current
50090-4066	Hydrocodone Bitartrate and Acetaminophen	Hydrocodone Bitartrate and Acetaminophen	A-S Medication Solutions	ANDA	Current
50090-4066	Hydrocodone Bitartrate and Acetaminophen	Hydrocodone Bitartrate and Acetaminophen	A-S Medication Solutions	ANDA	Current
50090-4071	Hydrocodone Bitartrate and Acetaminophen	Hydrocodone Bitartrate and Acetaminophen	A-S Medication Solutions	ANDA	Current
63629-2468	Hydrocodone Bitartrate and Acetaminophen	Hydrocodone Bitartrate and Acetaminophen	Bryant Ranch Prepack	ANDA	Current
63629-2468	Hydrocodone Bitartrate and Acetaminophen	Hydrocodone Bitartrate and Acetaminophen	Bryant Ranch Prepack	ANDA	Current
63629-2468	Hydrocodone Bitartrate and Acetaminophen	Hydrocodone Bitartrate and Acetaminophen	Bryant Ranch Prepack	ANDA	Current
63629-2469	Hydrocodone Bitartrate and Acetaminophen	Hydrocodone Bitartrate and Acetaminophen	Bryant Ranch Prepack	ANDA	Current
63629-2469	Hydrocodone Bitartrate and Acetaminophen	Hydrocodone Bitartrate and Acetaminophen	Bryant Ranch Prepack	ANDA	Current
63629-2469	Hydrocodone Bitartrate and Acetaminophen	Hydrocodone Bitartrate and Acetaminophen	Bryant Ranch Prepack	ANDA	Current
63629-2470	Hydrocodone Bitartrate and Acetaminophen	Hydrocodone Bitartrate and Acetaminophen	Bryant Ranch Prepack	ANDA	Current
63629-2470	Hydrocodone Bitartrate and Acetaminophen	Hydrocodone Bitartrate and Acetaminophen	Bryant Ranch Prepack	ANDA	Current
63629-2470	Hydrocodone Bitartrate and Acetaminophen	Hydrocodone Bitartrate and Acetaminophen	Bryant Ranch Prepack	ANDA	Current
63629-2471	Hydrocodone Bitartrate and Acetaminophen	Hydrocodone Bitartrate and Acetaminophen	Bryant Ranch Prepack	ANDA	Current
63629-2471	Hydrocodone Bitartrate and Acetaminophen	Hydrocodone Bitartrate and Acetaminophen	Bryant Ranch Prepack	ANDA	Current
63629-2471	Hydrocodone Bitartrate and Acetaminophen	Hydrocodone Bitartrate and Acetaminophen	Bryant Ranch Prepack	ANDA	Current
63629-8499	Hydrocodone Bitartrate and Acetaminophen	Hydrocodone Bitartrate and Acetaminophen	Bryant Ranch Prepack	ANDA	Current
63629-8499	Hydrocodone Bitartrate and Acetaminophen	Hydrocodone Bitartrate and Acetaminophen	Bryant Ranch Prepack	ANDA	Current
67296-1333	Hydrocodone Bitartrate and Acetaminophen	Hydrocodone Bitartrate and Acetaminophen	RedPharm Drug, Inc.	ANDA	Current
67296-1333	Hydrocodone Bitartrate and Acetaminophen	Hydrocodone Bitartrate and Acetaminophen	RedPharm Drug, Inc.	ANDA	Current
67296-1333	Hydrocodone Bitartrate and Acetaminophen	Hydrocodone Bitartrate and Acetaminophen	RedPharm Drug, Inc.	ANDA	Current
67296-1334	Hydrocodone Bitartrate and Acetaminophen	Hydrocodone Bitartrate and Acetaminophen	RedPharm Drug, Inc.	ANDA	Current
67296-1334	Hydrocodone Bitartrate and Acetaminophen	Hydrocodone Bitartrate and Acetaminophen	RedPharm Drug, Inc.	ANDA	Current
67296-1334	Hydrocodone Bitartrate and Acetaminophen	Hydrocodone Bitartrate and Acetaminophen	RedPharm Drug, Inc.	ANDA	Current
67296-1335	Hydrocodone Bitartrate and Acetaminophen	Hydrocodone Bitartrate and Acetaminophen	RedPharm Drug, Inc.	ANDA	Current
67296-1335	Hydrocodone Bitartrate and Acetaminophen	Hydrocodone Bitartrate and Acetaminophen	RedPharm Drug, Inc.	ANDA	Current
67296-1335	Hydrocodone Bitartrate and Acetaminophen	Hydrocodone Bitartrate and Acetaminophen	RedPharm Drug, Inc.	ANDA	Current
71335-1417	Hydrocodone Bitartrate and Acetaminophen	Hydrocodone Bitartrate and Acetaminophen	Bryant Ranch Prepack	ANDA	Current
71335-1417	Hydrocodone Bitartrate and Acetaminophen	Hydrocodone Bitartrate and Acetaminophen	Bryant Ranch Prepack	ANDA	Current
71335-1418	Hydrocodone Bitartrate and Acetaminophen	Hydrocodone Bitartrate and Acetaminophen	Bryant Ranch Prepack	ANDA	Current
71335-1418	Hydrocodone Bitartrate and Acetaminophen	Hydrocodone Bitartrate and Acetaminophen	Bryant Ranch Prepack	ANDA	Current
71335-1419	Hydrocodone Bitartrate and Acetaminophen	Hydrocodone Bitartrate and Acetaminophen	Bryant Ranch Prepack	ANDA	Current
71335-1419	Hydrocodone Bitartrate and Acetaminophen	Hydrocodone Bitartrate and Acetaminophen	Bryant Ranch Prepack	ANDA	Current
71335-1444	Hydrocodone Bitartrate and Acetaminophen	Hydrocodone Bitartrate and Acetaminophen	Bryant Ranch Prepack	ANDA	Current
71335-1444	Hydrocodone Bitartrate and Acetaminophen	Hydrocodone Bitartrate and Acetaminophen	Bryant Ranch Prepack	ANDA	Current
71335-1444	Hydrocodone Bitartrate and Acetaminophen	Hydrocodone Bitartrate and Acetaminophen	Bryant Ranch Prepack	ANDA	Current
71335-1444	Hydrocodone Bitartrate and Acetaminophen	Hydrocodone Bitartrate and Acetaminophen	Bryant Ranch Prepack	ANDA	Current
71335-1444	Hydrocodone Bitartrate and Acetaminophen	Hydrocodone Bitartrate and Acetaminophen	Bryant Ranch Prepack	ANDA	Current
71335-1470	Hydrocodone Bitartrate and Acetaminophen	Hydrocodone Bitartrate and Acetaminophen	Bryant Ranch Prepack	ANDA	Current
71335-1470	Hydrocodone Bitartrate and Acetaminophen	Hydrocodone Bitartrate and Acetaminophen	Bryant Ranch Prepack	ANDA	Current
71335-1470	Hydrocodone Bitartrate and Acetaminophen	Hydrocodone Bitartrate and Acetaminophen	Bryant Ranch Prepack	ANDA	Current
71335-1557	Hydrocodone Bitartrate and Acetaminophen	Hydrocodone Bitartrate and Acetaminophen	Bryant Ranch Prepack	ANDA	Current
71335-1557	Hydrocodone Bitartrate and Acetaminophen	Hydrocodone Bitartrate and Acetaminophen	Bryant Ranch Prepack	ANDA	Current
71335-1557	Hydrocodone Bitartrate and Acetaminophen	Hydrocodone Bitartrate and Acetaminophen	Bryant Ranch Prepack	ANDA	Current
71335-1811	Hydrocodone Bitartrate and Acetaminophen	Hydrocodone Bitartrate and Acetaminophen	Bryant Ranch Prepack	ANDA	Current
76420-133	Hydrocodone Bitartrate and Acetaminophen	Hydrocodone Bitartrate and Acetaminophen	Asclemed USA, Inc.	ANDA	Current
76420-133	Hydrocodone Bitartrate and Acetaminophen	Hydrocodone Bitartrate and Acetaminophen	Asclemed USA, Inc.	ANDA	Current
76420-215	Hydrocodone Bitartrate and Acetaminophen	Hydrocodone Bitartrate and Acetaminophen	Asclemed USA, Inc.	ANDA	Current
76420-257	Hydrocodone Bitartrate and Acetaminophen	Hydrocodone Bitartrate and Acetaminophen	Asclemed USA, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
76160	ORIG	2023-11-03