HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product NDC: 52959-735
11-digit product format: 529590735
Labeler code: 52959
Product ID: 52959-735_76a6db83-d074-39b6-e053-2991aa0adac1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Dosage form: TABLET
Route: ORAL
Labeler: H.J. Harkins Company, Inc.
Application: ANDA201013
Marketing category: ANDA
Marketing start: 2015-12-29
Marketing end: 0000-00-00
Substance: HYDROCODONE BITARTRATE; ACETAMINOPHEN
Active strength: 8 mg/1; mg/1
Pharmacologic classes: Opioid Agonist [EPC],Opioid Agonists [MoA]
DEA schedule: CII
NDC exclude flag: No
Listing certified through: 2019-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 18 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	52959-735		I	Inactivated by FDA	2026-08-17
excluded package	package	52959-735	52959-735-00	I	Inactivated by FDA	2026-08-17
excluded package	package	52959-735	52959-735-02	I	Inactivated by FDA	2026-08-17
excluded package	package	52959-735	52959-735-03	I	Inactivated by FDA	2026-08-17
excluded package	package	52959-735	52959-735-10	I	Inactivated by FDA	2026-08-17
excluded package	package	52959-735	52959-735-12	I	Inactivated by FDA	2026-08-17
excluded package	package	52959-735	52959-735-15	I	Inactivated by FDA	2026-08-17
excluded package	package	52959-735	52959-735-20	I	Inactivated by FDA	2026-08-17
excluded package	package	52959-735	52959-735-24	I	Inactivated by FDA	2026-08-17
excluded package	package	52959-735	52959-735-28	I	Inactivated by FDA	2026-08-17
excluded package	package	52959-735	52959-735-30	I	Inactivated by FDA	2026-08-17
excluded package	package	52959-735	52959-735-40	I	Inactivated by FDA	2026-08-17
excluded package	package	52959-735	52959-735-42	I	Inactivated by FDA	2026-08-17
excluded package	package	52959-735	52959-735-50	I	Inactivated by FDA	2026-08-17
excluded package	package	52959-735	52959-735-60	I	Inactivated by FDA	2026-08-17
excluded package	package	52959-735	52959-735-80	I	Inactivated by FDA	2026-08-17
excluded package	package	52959-735	52959-735-84	I	Inactivated by FDA	2026-08-17
excluded package	package	52959-735	52959-735-90	I	Inactivated by FDA	2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 7 · 378 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-735-20	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-735-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-735-40	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-735-15	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-735-42	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-735-28	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-735-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-735-84	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-735-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-735-50	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-735-80	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-735-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-735-24	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-735-90	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-735-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-735-12	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-735-00	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-735-20	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-735-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-735-40	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-735-15	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-735-42	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-735-28	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-735-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-735-84	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-735-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-735-50	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-735-80	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-735-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-735-24	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-735-90	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-735-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-735-12	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-735-00	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-735-20	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-735-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-735-40	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-735-15	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-735-42	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-735-28	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-735-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-735-84	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-735-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-735-50	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-735-80	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-735-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-735-24	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-735-90	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-735-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-735-12	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-735-00	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-735-20	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-735-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-735-40	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-735-15	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-735-42	`a1b67e2a42f9…`	`c4cf2c586c0d…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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 · 126 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
2026-08-18 06:07:40	2026-07	A201013-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2012-04-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201013-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2012-04-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201013-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2012-04-11	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A201013-001	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201013-002	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201013-003	AA	1	`caaa826d4ba7…`
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…`

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, Related label table
NDC	Related label
52959-735-00	0735 HYDRO/APAP 7.5/325MG
52959-735-02	0735 HYDRO/APAP 7.5/325MG
52959-735-03	0735 HYDRO/APAP 7.5/325MG
52959-735-10	0735 HYDRO/APAP 7.5/325MG
52959-735-12	0735 HYDRO/APAP 7.5/325MG
52959-735-15	0735 HYDRO/APAP 7.5/325MG
52959-735-20	0735 HYDRO/APAP 7.5/325MG
52959-735-24	0735 HYDRO/APAP 7.5/325MG
52959-735-28	0735 HYDRO/APAP 7.5/325MG
52959-735-30	0735 HYDRO/APAP 7.5/325MG
52959-735-40	0735 HYDRO/APAP 7.5/325MG
52959-735-42	0735 HYDRO/APAP 7.5/325MG
52959-735-50	0735 HYDRO/APAP 7.5/325MG
52959-735-60	0735 HYDRO/APAP 7.5/325MG
52959-735-80	0735 HYDRO/APAP 7.5/325MG
52959-735-84	0735 HYDRO/APAP 7.5/325MG
52959-735-90	0735 HYDRO/APAP 7.5/325MG

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
52959-735-00	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	100 in 1 BOTTLE	TABLET	100	1
52959-735-02	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	120 in 1 BOTTLE	TABLET	120	1
52959-735-03	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	126 in 1 BOTTLE	TABLET	126	1
52959-735-10	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	10 in 1 BOTTLE	TABLET	10	1
52959-735-12	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	12 in 1 BOTTLE	TABLET	12	1
52959-735-15	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	15 in 1 BOTTLE	TABLET	15	1
52959-735-20	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	20 in 1 BOTTLE	TABLET	20	1
52959-735-24	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	24 in 1 BOTTLE	TABLET	24	1
52959-735-28	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	28 in 1 BOTTLE	TABLET	28	1
52959-735-30	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	30 in 1 BOTTLE	TABLET	30	1
52959-735-40	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	40 in 1 BOTTLE	TABLET	40	1
52959-735-42	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	42 in 1 BOTTLE	TABLET	42	1
52959-735-50	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	50 in 1 BOTTLE	TABLET	50	1
52959-735-60	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	60 in 1 BOTTLE	TABLET	60	1
52959-735-80	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	80 in 1 BOTTLE	TABLET	80	1
52959-735-84	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	84 in 1 BOTTLE	TABLET	84	1
52959-735-90	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	90 in 1 BOTTLE	TABLET	90	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
52959-735-00	EA - Each	52959-735	1f1a004b-21ce-4e61-b26d-be627343479e	1	2018-10-11
52959-735-02	EA - Each	52959-735	5f522ef0-4ca0-48c8-9dde-1c207d8abfdd	1	2018-10-11
52959-735-03	EA - Each	52959-735	ce0141f9-9e95-4980-86a6-0ee25334cf2c	1	2018-10-11
52959-735-30	EA - Each	52959-735	b0489c00-6f63-44b5-8ceb-64c4f4390d97	1	2018-10-11
52959-735-40	EA - Each	52959-735	179c5cd7-b7d4-4721-b36b-9b443755eaa7	1	2018-10-11
52959-735-50	EA - Each	52959-735	88dd3edc-9d9a-41fd-a203-1da838df4913	1	2018-10-11
52959-735-60	EA - Each	52959-735	c2299822-a313-491c-b46e-ab8dd19a58e0	1	2018-10-11
52959-735-80	EA - Each	52959-735	8a318dd3-7d70-4909-a40f-94534e9488f4	1	2018-10-11
52959-735-84	EA - Each	52959-735	fc9a289b-5e20-4805-8ead-df7fbca09759	1	2018-10-11
52959-735-90	EA - Each	52959-735	ac1abaa0-e692-4044-a522-5a4d5ca35b14	1	2018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52959-735	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [H.J. HARKINS COMPANY, INC.]	1	Legacy NDC, 17 package rows	20180925_76a6db83-d073-39b6-e053-2991aa0adac1.zip

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 · 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
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

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

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	76a6db83-d073-39b6-e053-2991aa0adac1	1
857005	acetaminophen 325 MG / hydrocodone bitartrate 7.5 MG Oral Tablet	SCD	76a6db83-d073-39b6-e053-2991aa0adac1	1
857005	APAP 325 MG / hydrocodone bitartrate 7.5 MG Oral Tablet	SY	76a6db83-d073-39b6-e053-2991aa0adac1	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
52959-735-00	52959073500	100 in 1 BOTTLE	Historical
52959-735-02	52959073502	120 in 1 BOTTLE	Historical
52959-735-03	52959073503	126 in 1 BOTTLE	Historical
52959-735-10	52959073510	10 in 1 BOTTLE	Historical
52959-735-12	52959073512	12 in 1 BOTTLE	Historical
52959-735-15	52959073515	15 in 1 BOTTLE	Historical
52959-735-20	52959073520	20 in 1 BOTTLE	Historical
52959-735-24	52959073524	24 in 1 BOTTLE	Historical
52959-735-28	52959073528	28 in 1 BOTTLE	Historical
52959-735-30	52959073530	30 in 1 BOTTLE	Historical
52959-735-40	52959073540	40 in 1 BOTTLE	Historical
52959-735-42	52959073542	42 in 1 BOTTLE	Historical
52959-735-50	52959073550	50 in 1 BOTTLE	Historical
52959-735-60	52959073560	60 in 1 BOTTLE	Historical
52959-735-80	52959073580	80 in 1 BOTTLE	Historical
52959-735-84	52959073584	84 in 1 BOTTLE	Historical
52959-735-90	52959073590	90 in 1 BOTTLE	Historical