Hydrocodone Bitartrate and Acetaminophen

Product NDC: 71335-0108
11-digit product format: 713350108
Labeler code: 71335
Product ID: 71335-0108_938a574e-dc14-4a18-a353-aaf96eb5bf66
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Hydrocodone Bitartrate and Acetaminophen
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA201013
Marketing category: ANDA
Marketing start: 2012-04-11
Substance: ACETAMINOPHEN; HYDROCODONE BITARTRATE
Active strength: 325; 7.5 mg/1; mg/1
Pharmacologic classes: Opioid Agonist [EPC], Opioid Agonists [MoA]
DEA schedule: CII
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Observed NDC auxiliary status history#

Observed captured status history: Rows come only from successfully parsed FDA auxiliary ZIP captures. They show the state present in that artifact, not a continuous regulatory timeline. Absence before, after, or between captures is not proof of status, and a known non-data HTTP 403 capture is preserved in backfill provenance but cannot produce a status row.

Historic NDC status page 1 of 1 · 33 matching rows.

Browse every current auxiliary row. · Browse the complete NDC auxiliary source catalog.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product	71335-0108		I	Inactivated by FDA	excluded / ndc_excluded.zip	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	71335-0108	71335-0108-3	I	Inactivated by FDA	excluded / ndc_excluded.zip	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	71335-0108	71335-0108-5	I	Inactivated by FDA	excluded / ndc_excluded.zip	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	71335-0108	71335-0108-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	71335-0108	71335-0108-4	I	Inactivated by FDA	excluded / ndc_excluded.zip	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	71335-0108	71335-0108-6	I	Inactivated by FDA	excluded / ndc_excluded.zip	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	71335-0108	71335-0108-0	I	Inactivated by FDA	excluded / ndc_excluded.zip	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	71335-0108	71335-0108-2	I	Inactivated by FDA	excluded / ndc_excluded.zip	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	71335-0108	71335-0108-9	I	Inactivated by FDA	excluded / ndc_excluded.zip	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	71335-0108	71335-0108-8	I	Inactivated by FDA	excluded / ndc_excluded.zip	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	71335-0108	71335-0108-7	I	Inactivated by FDA	excluded / ndc_excluded.zip	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product	71335-0108		I	Inactivated by FDA	excluded / ndc_excluded.zip	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	71335-0108	71335-0108-3	I	Inactivated by FDA	excluded / ndc_excluded.zip	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	71335-0108	71335-0108-5	I	Inactivated by FDA	excluded / ndc_excluded.zip	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	71335-0108	71335-0108-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	71335-0108	71335-0108-4	I	Inactivated by FDA	excluded / ndc_excluded.zip	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	71335-0108	71335-0108-6	I	Inactivated by FDA	excluded / ndc_excluded.zip	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	71335-0108	71335-0108-0	I	Inactivated by FDA	excluded / ndc_excluded.zip	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	71335-0108	71335-0108-2	I	Inactivated by FDA	excluded / ndc_excluded.zip	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	71335-0108	71335-0108-9	I	Inactivated by FDA	excluded / ndc_excluded.zip	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	71335-0108	71335-0108-8	I	Inactivated by FDA	excluded / ndc_excluded.zip	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	71335-0108	71335-0108-7	I	Inactivated by FDA	excluded / ndc_excluded.zip	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product	71335-0108		I	Inactivated by FDA	excluded / ndc_excluded.zip	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	71335-0108	71335-0108-3	I	Inactivated by FDA	excluded / ndc_excluded.zip	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	71335-0108	71335-0108-5	I	Inactivated by FDA	excluded / ndc_excluded.zip	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	71335-0108	71335-0108-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	71335-0108	71335-0108-4	I	Inactivated by FDA	excluded / ndc_excluded.zip	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	71335-0108	71335-0108-6	I	Inactivated by FDA	excluded / ndc_excluded.zip	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	71335-0108	71335-0108-0	I	Inactivated by FDA	excluded / ndc_excluded.zip	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	71335-0108	71335-0108-2	I	Inactivated by FDA	excluded / ndc_excluded.zip	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	71335-0108	71335-0108-9	I	Inactivated by FDA	excluded / ndc_excluded.zip	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	71335-0108	71335-0108-8	I	Inactivated by FDA	excluded / ndc_excluded.zip	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	71335-0108	71335-0108-7	I	Inactivated by FDA	excluded / ndc_excluded.zip	`1332a3947898…`	`d4bfe170f9cd…`

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
A201013-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	ACETAMINOPHEN; HYDROCODONE BITARTRATE	325MG;5MG	TABLET / ORAL	AA	2012-04-11
A201013-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	ACETAMINOPHEN; HYDROCODONE BITARTRATE	325MG;7.5MG	TABLET / ORAL	AA	2012-04-11
A201013-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	ACETAMINOPHEN; HYDROCODONE BITARTRATE	325MG;10MG	TABLET / ORAL	AA	2012-04-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A201013-001	AA
A201013-002	AA
A201013-003	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	A201013-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2012-04-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201013-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2012-04-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201013-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2012-04-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201013-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2012-04-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201013-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2012-04-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201013-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2012-04-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201013-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2012-04-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201013-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2012-04-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201013-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2012-04-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201013-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2012-04-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201013-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2012-04-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201013-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2012-04-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201013-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2012-04-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201013-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2012-04-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201013-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2012-04-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201013-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2012-04-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201013-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2012-04-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201013-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2012-04-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201013-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2012-04-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201013-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2012-04-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201013-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2012-04-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201013-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2012-04-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201013-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2012-04-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201013-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2012-04-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201013-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2012-04-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201013-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2012-04-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201013-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2012-04-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201013-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2012-04-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201013-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2012-04-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201013-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2012-04-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201013-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2012-04-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201013-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2012-04-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201013-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2012-04-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201013-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2012-04-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201013-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2012-04-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201013-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2012-04-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201013-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2012-04-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201013-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2012-04-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201013-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2012-04-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201013-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2012-04-11	`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	A201013-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201013-002	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201013-003	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201013-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201013-002	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201013-003	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201013-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201013-002	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201013-003	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201013-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201013-002	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201013-003	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201013-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201013-002	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201013-003	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201013-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201013-002	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201013-003	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201013-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201013-002	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201013-003	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201013-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201013-002	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201013-003	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201013-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201013-002	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201013-003	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201013-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201013-002	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201013-003	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201013-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201013-002	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201013-003	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201013-001	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201013-002	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201013-003	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201013-001	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201013-002	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201013-003	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201013-001	AA	1	`8072bd15b7f6…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 11 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	ddfe71cc-27bf-4807-b62f-e6cf982e2dfd	2026-06-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201013 application number: ANDA201013
Hydrocodone Bitartrate and Acetaminophen	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	Bryant Ranch Prepack	88c031ee-3d3d-4e8a-b69b-d18db612a9f3	2026-01-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201013 application number: ANDA201013
Hydrocodone Bitartrate and Acetaminophen	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	Aurolife Pharma, LLC	60f43308-1deb-4f05-8f17-aa49ebdcf498	2025-12-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201013 application number: ANDA201013
Hydrocodone Bitartrate and Acetaminophen	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	Bryant Ranch Prepack	59a92d79-5b2d-4c10-b0ac-ea766a0ff08b	2024-10-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201013 application number: ANDA201013 ndc (product): 71335-0108
Hydrocodone Bitartrate and Acetaminophen	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	NuCare Pharmaceuticals,Inc.	8b132cf3-c138-59ae-e053-2995a90a98a2	2024-08-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201013 application number: ANDA201013
Hydrocodone Bitartrate and Acetaminophen	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	NuCare Pharmaceuticals,Inc.	8c2a7a68-5a84-c909-e053-2995a90ad5b6	2024-06-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201013 application number: ANDA201013
Hydrocodone Bitartrate and Acetaminophen	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	NuCare Pharmaceuticals,Inc.	8592e901-9353-6fb6-e053-2a91aa0ad33b	2024-06-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201013 application number: ANDA201013
Hydrocodone Bitartrate and Acetaminophen	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	NuCare Pharmaceuticals,Inc.	86be8920-2f35-fbc3-e053-2991aa0a0015	2024-06-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201013 application number: ANDA201013
Hydrocodone Bitartrate and Acetaminophen	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	Proficient Rx LP	82b24978-8b15-43a9-b5b0-3313ed2a73c2	2023-04-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201013 application number: ANDA201013
Hydrocodone Bitartrate and Acetaminophen	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	Proficient Rx LP	e6711f26-a01d-43e8-882a-d58561e4b67f	2022-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201013 application number: ANDA201013
Hydrocodone Bitartrate and Acetaminophen	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	Proficient Rx LP	199d4915-cb3b-48f3-835d-a45d04a5c940	2022-04-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201013 application number: ANDA201013

Additional Listing Data#

Finished product: Yes
Brand name base: Hydrocodone Bitartrate and Acetaminophen
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
HYDROCODONE BITARTRATE	325 mg/1
ACETAMINOPHEN	7.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
NO70W886KK	Internal UNII lookup
362O9ITL9D	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
857005	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
59a92d79-5b2d-4c10-b0ac-ea766a0ff08b	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
06cc817f-60e0-4473-8e6b-c44d11dc5af6	Product name	9	20220921
53523715-c529-4d52-b9ff-1e5d76636f53	Product name	2	20210818
31b11e56-5b35-4ab6-a3a8-f0b48973dced	Product name	2	20200611
3a16d77a-e865-468a-aedf-6e58913c1c21	Product name	3	20190619
00d531e4-b130-8c52-eaf9-826cbb6f15dd	Product name	3	20190205
aa0f353d-f35e-62e4-4e1f-5b563f01c659	Product name	9	20190205
22d922aa-c443-d9f3-b23c-03b03a9ad31c	Product name	7	20181220
7855f8e3-562e-4273-8b79-0059c07a71f7	Product name	1	20170901
d17a97fa-387f-690e-d2be-0083ab044a03	Product name	3	20170725
0fdb98e2-b951-a1ce-5715-2b187ba500ef	Product name	4	20170718
a5244f9c-cd67-0e27-d63b-65fd7e584400	Product name	2	20170504
b654f2d9-ebeb-451d-96ee-22f583344623	Product name	1	20170424
557673c2-8256-b351-e863-4ec71a5a64b0	Product name	2	20160714
e974e22d-8688-7d92-1e87-40c1079e170c	Product name	3	20151125
4fe95224-f543-4dbb-9445-8cca122b48c8	Product name	1	20150609
e8718272-64cb-4436-969b-176c3067c8f4	Product name	1	20150609
106ff02a-57e1-4c4c-a307-fd582ff4e311	Product name	1	20150212
105ef617-6fa4-6713-326f-72ec8a6b75a9	Product name	1	20140508
53855190-7124-8179-f018-e792f7c27f28	Product name	1	20140508
61c18d4e-b552-5478-8fc0-df38b93e3100	Product name	1	20140508
84fb0b3d-1d72-b672-bc70-2b676a23e7e0	Product name	1	20140508
b8e0daf1-fb81-290b-c0bf-873be19ef775	Product name	1	20140508
d83c592c-dd97-4cbf-36ac-13da806684bd	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
71335-0108-0	2024-05-30	C162847	48780-1	1030e365-2eac-111a-e063-dadaa90a10e2	Hydrocodone Bitartrate and Acetaminophen Tablets, USP
71335-0108-1	2024-05-30	C162847	48780-1	1030e365-2eac-111a-e063-dadaa90a10e2	Hydrocodone Bitartrate and Acetaminophen Tablets, USP
71335-0108-2	2024-05-30	C162847	48780-1	1030e365-2eac-111a-e063-dadaa90a10e2	Hydrocodone Bitartrate and Acetaminophen Tablets, USP
71335-0108-3	2024-05-30	C162847	48780-1	1030e365-2eac-111a-e063-dadaa90a10e2	Hydrocodone Bitartrate and Acetaminophen Tablets, USP
71335-0108-4	2024-05-30	C162847	48780-1	1030e365-2eac-111a-e063-dadaa90a10e2	Hydrocodone Bitartrate and Acetaminophen Tablets, USP
71335-0108-5	2024-05-30	C162847	48780-1	1030e365-2eac-111a-e063-dadaa90a10e2	Hydrocodone Bitartrate and Acetaminophen Tablets, USP
71335-0108-6	2024-05-30	C162847	48780-1	1030e365-2eac-111a-e063-dadaa90a10e2	Hydrocodone Bitartrate and Acetaminophen Tablets, USP
71335-0108-7	2024-05-30	C162847	48780-1	1030e365-2eac-111a-e063-dadaa90a10e2	Hydrocodone Bitartrate and Acetaminophen Tablets, USP
71335-0108-8	2024-05-30	C162847	48780-1	1030e365-2eac-111a-e063-dadaa90a10e2	Hydrocodone Bitartrate and Acetaminophen Tablets, USP
71335-0108-9	2024-05-30	C162847	48780-1	1030e365-2eac-111a-e063-dadaa90a10e2	Hydrocodone Bitartrate and Acetaminophen Tablets, USP
71335-0108-0	2024-01-30	C162847	48780-1	1030e365-2eac-111a-e063-dadaa90a10e2	Hydrocodone Bitartrate and Acetaminophen Tablets, USP
71335-0108-1	2024-01-30	C162847	48780-1	1030e365-2eac-111a-e063-dadaa90a10e2	Hydrocodone Bitartrate and Acetaminophen Tablets, USP
71335-0108-2	2024-01-30	C162847	48780-1	1030e365-2eac-111a-e063-dadaa90a10e2	Hydrocodone Bitartrate and Acetaminophen Tablets, USP
71335-0108-3	2024-01-30	C162847	48780-1	1030e365-2eac-111a-e063-dadaa90a10e2	Hydrocodone Bitartrate and Acetaminophen Tablets, USP
71335-0108-4	2024-01-30	C162847	48780-1	1030e365-2eac-111a-e063-dadaa90a10e2	Hydrocodone Bitartrate and Acetaminophen Tablets, USP
71335-0108-5	2024-01-30	C162847	48780-1	1030e365-2eac-111a-e063-dadaa90a10e2	Hydrocodone Bitartrate and Acetaminophen Tablets, USP
71335-0108-6	2024-01-30	C162847	48780-1	1030e365-2eac-111a-e063-dadaa90a10e2	Hydrocodone Bitartrate and Acetaminophen Tablets, USP
71335-0108-7	2024-01-30	C162847	48780-1	1030e365-2eac-111a-e063-dadaa90a10e2	Hydrocodone Bitartrate and Acetaminophen Tablets, USP
71335-0108-8	2024-01-30	C162847	48780-1	1030e365-2eac-111a-e063-dadaa90a10e2	Hydrocodone Bitartrate and Acetaminophen Tablets, USP
71335-0108-9	2024-01-30	C162847	48780-1	1030e365-2eac-111a-e063-dadaa90a10e2	Hydrocodone Bitartrate and Acetaminophen Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
71335-0108-0	Hydrocodone Bitartrate and Acetaminophen	8 in 1 BOTTLE	TABLET	8	8
71335-0108-1	Hydrocodone Bitartrate and Acetaminophen	120 in 1 BOTTLE	TABLET	120	8
71335-0108-2	Hydrocodone Bitartrate and Acetaminophen	15 in 1 BOTTLE	TABLET	15	8
71335-0108-3	Hydrocodone Bitartrate and Acetaminophen	20 in 1 BOTTLE	TABLET	20	8
71335-0108-4	Hydrocodone Bitartrate and Acetaminophen	28 in 1 BOTTLE	TABLET	28	8
71335-0108-5	Hydrocodone Bitartrate and Acetaminophen	30 in 1 BOTTLE	TABLET	30	8
71335-0108-6	Hydrocodone Bitartrate and Acetaminophen	40 in 1 BOTTLE	TABLET	40	8
71335-0108-7	Hydrocodone Bitartrate and Acetaminophen	56 in 1 BOTTLE	TABLET	56	8
71335-0108-8	Hydrocodone Bitartrate and Acetaminophen	60 in 1 BOTTLE	TABLET	60	8
71335-0108-9	Hydrocodone Bitartrate and Acetaminophen	90 in 1 BOTTLE	TABLET	90	8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71335-0108-1	EA - Each	71335-0108	6a45f044-c21f-4d3a-94e9-0077a178c045	1	2018-09-05
71335-0108-5	EA - Each	71335-0108	3395b374-a934-4af5-b779-c98144e336ad	1	2018-09-05
71335-0108-6	EA - Each	71335-0108	ed7c8582-0280-4628-9602-568c7fd757e6	1	2018-06-11
71335-0108-8	EA - Each	71335-0108	31453872-6951-4ad6-9419-275ec55dbf85	1	2018-07-03
71335-0108-9	EA - Each	71335-0108	9c417bf9-0446-4f4d-a2d3-b84a4a7c1cd7	1	2018-07-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71335-0108	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [BRYANT RANCH PREPACK]	8	Current NDC, Legacy NDC, 10 package rows	20241024_59a92d79-5b2d-4c10-b0ac-ea766a0ff08b.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
362O9ITL9D	ACETAMINOPHEN	103-90-2	ACETAMINOPHEN
NO70W886KK	HYDROCODONE BITARTRATE	34195-34-1	HYDROCODONE BITARTRATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
857005	HYDROcodone bitartrate 7.5 MG / acetaminophen 325 MG Oral Tablet	PSN	59a92d79-5b2d-4c10-b0ac-ea766a0ff08b	8
857005	acetaminophen 325 MG / hydrocodone bitartrate 7.5 MG Oral Tablet	SCD	59a92d79-5b2d-4c10-b0ac-ea766a0ff08b	8
857005	APAP 325 MG / hydrocodone bitartrate 7.5 MG Oral Tablet	SY	59a92d79-5b2d-4c10-b0ac-ea766a0ff08b	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71335-0108-0	71335010800	8 TABLET in 1 BOTTLE (71335-0108-0)	8 tablet	2018-12-12	0000-00-00	No	No	Current
71335-0108-1	71335010801	120 TABLET in 1 BOTTLE (71335-0108-1)	120 tablet	2018-06-06	0000-00-00	No	No	Current
71335-0108-2	71335010802	15 TABLET in 1 BOTTLE (71335-0108-2)	15 tablet	2018-12-11	0000-00-00	No	No	Current
71335-0108-3	71335010803	20 TABLET in 1 BOTTLE (71335-0108-3)	20 tablet	2018-07-09	0000-00-00	No	No	Current
71335-0108-4	71335010804	28 TABLET in 1 BOTTLE (71335-0108-4)	28 tablet	2019-09-04	0000-00-00	No	No	Current
71335-0108-5	71335010805	30 TABLET in 1 BOTTLE (71335-0108-5)	30 tablet	2018-06-28	0000-00-00	No	No	Current
71335-0108-6	71335010806	40 TABLET in 1 BOTTLE (71335-0108-6)	40 tablet	2018-05-30	0000-00-00	No	No	Current
71335-0108-7	71335010807	56 TABLET in 1 BOTTLE (71335-0108-7)	56 tablet	2024-10-08	0000-00-00	No	No	Current
71335-0108-8	71335010808	60 TABLET in 1 BOTTLE (71335-0108-8)	60 tablet	2018-05-22	0000-00-00	No	No	Current
71335-0108-9	71335010809	90 TABLET in 1 BOTTLE (71335-0108-9)	90 tablet	2018-05-31	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Hydrocodone Bitartrate and Acetaminophen Tablets, USP	Bryant Ranch Prepack	2024-10-08	HUMAN PRESCRIPTION DRUG LABEL	8