Hydrocodone Bitartate and Acetaminophen

Product NDC: 33261-881
11-digit product format: 332610881
Labeler code: 33261
Product ID: 33261-881_e56d4c76-f449-4402-937e-b64cf8e20047
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: HYDROCODONE BITARTRATE, ACETAMINOPHEN
Dosage form: TABLET
Route: ORAL
Labeler: Aidarex Pharmaceuticals LLC
Application: ANDA040846
Marketing category: ANDA
Marketing start: 2012-05-17
Marketing end: 0000-00-00
Substance: HYDROCODONE BITARTRATE; ACETAMINOPHEN
Active strength: 3 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 · 6 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	33261-881		I	Inactivated by FDA	2026-08-03
excluded package	package	33261-881	33261-881-00	I	Inactivated by FDA	2026-08-03
excluded package	package	33261-881	33261-881-02	I	Inactivated by FDA	2026-08-03
excluded package	package	33261-881	33261-881-30	I	Inactivated by FDA	2026-08-03
excluded package	package	33261-881	33261-881-60	I	Inactivated by FDA	2026-08-03
excluded package	package	33261-881	33261-881-90	I	Inactivated by FDA	2026-08-03

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 3 · 126 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	33261-881-00	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	33261-881-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	33261-881-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	33261-881-90	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	33261-881-30	`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	33261-881-00	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	33261-881-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	33261-881-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	33261-881-90	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	33261-881-30	`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	33261-881-00	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	33261-881-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	33261-881-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	33261-881-90	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	33261-881-30	`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	33261-881-00	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	33261-881-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	33261-881-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	33261-881-90	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	33261-881-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	33261-881-00	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	33261-881-60	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	33261-881-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	33261-881-90	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	33261-881-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	33261-881-00	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	33261-881-60	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	33261-881-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	33261-881-90	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	33261-881-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	33261-881-00	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	33261-881-60	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	33261-881-02	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	33261-881-90	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	33261-881-30	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	33261-881-00	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	33261-881-60	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	33261-881-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	33261-881-90	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	33261-881-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	33261-881-00	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	33261-881-60	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	33261-881-02	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	33261-881-90	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	33261-881-30	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	33261-881-00	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	33261-881-60	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	33261-881-02	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	33261-881-90	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	33261-881-30	`ad56d346431e…`	`cc804d4bbf1e…`

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A040846-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	ACETAMINOPHEN; HYDROCODONE BITARTRATE	325MG;2.5MG	TABLET / ORAL			2010-06-09

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 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A040846-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL			2010-06-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040846-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL			2010-06-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040846-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL			2010-06-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040846-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL			2010-06-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040846-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL			2010-06-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040846-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL			2010-06-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040846-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL			2010-06-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040846-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL			2010-06-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040846-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL			2010-06-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040846-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL			2010-06-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040846-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL			2010-06-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040846-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL			2010-06-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040846-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL			2010-06-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040846-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL			2010-06-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040846-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL			2010-06-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040846-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL	AA	RS	2010-06-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040846-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL	AA	RS	2010-06-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040846-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL	AA	RS	2010-06-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040846-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL	AA	RS	2010-06-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040846-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL	AA	RS	2010-06-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040846-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL	AA	RS	2010-06-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040846-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL	AA	RS	2010-06-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040846-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL	AA	RS	2010-06-09	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040846-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL	AA	RS	2010-06-09	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040846-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL	AA	RS	2010-06-09	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040846-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL	AA	RS	2010-06-09	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040846-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL	AA	RS	2010-06-09	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040846-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL			2010-06-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040846-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL			2010-06-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040846-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL			2010-06-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040846-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL			2010-06-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040846-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL			2010-06-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040846-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL			2010-06-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040846-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL			2010-06-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040846-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL			2010-06-09	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040846-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL			2010-06-09	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040846-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL			2010-06-09	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040846-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL			2010-06-09	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040846-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL			2010-06-09	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040846-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL			2010-06-09	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-04-08 23:34 UTC	2022-04	A040846-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040846-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040846-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040846-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040846-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040846-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040846-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040846-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040846-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040846-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040846-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040846-001	AA	1	`ea99ee380514…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
75d4bef7-334c-4a95-abb5-bff9def24114	Product name	2	20260112
7dea7767-9f52-b60a-5435-33cb9cc28bae	Product name	4	20250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4	Product name	7	20250116
11939cf5-0ea7-5df5-5127-00a7ce07fd7f	Product name	5	20250115
0ca83774-3f79-b837-5d6f-c210102f3bc8	Product name	6	20250114
88300afc-e1c4-ad17-c80b-4957f1b809a5	Product name	5	20250113
4eddd6ca-259a-4c6c-a3a4-2025015ce043	Product name	7	20240611
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53523715-c529-4d52-b9ff-1e5d76636f53	Product name	2	20210818
31b11e56-5b35-4ab6-a3a8-f0b48973dced	Product name	2	20200611
103b151b-b17f-42ac-8624-3ef62f5e2975	Product name	2	20200507
b8497372-efe9-9dde-fa2d-59be9761aa64	Product name	9	20200428
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3a16d77a-e865-468a-aedf-6e58913c1c21	Product name	3	20190619
2a0c98e1-033f-4e0d-a0da-b5291ffbe880	Product name	1	20190320
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
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377068df-225f-7318-a910-a1987cdfa361	Product name	3	20170608
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53855190-7124-8179-f018-e792f7c27f28	Product name	1	20140508
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FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
33261-881-00	Hydrocodone Bitartrate and Acetaminophen Tablets USP 2.5 mg/325 mg Rx only
33261-881-02	Hydrocodone Bitartrate and Acetaminophen Tablets USP 2.5 mg/325 mg Rx only
33261-881-30	Hydrocodone Bitartrate and Acetaminophen Tablets USP 2.5 mg/325 mg Rx only
33261-881-60	Hydrocodone Bitartrate and Acetaminophen Tablets USP 2.5 mg/325 mg Rx only
33261-881-90	Hydrocodone Bitartrate and Acetaminophen Tablets USP 2.5 mg/325 mg Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
33261-881-00	Hydrocodone Bitartate and Acetaminophen	100 in 1 BOTTLE, PLASTIC	TABLET	100	3
33261-881-02	Hydrocodone Bitartate and Acetaminophen	120 in 1 BOTTLE, PLASTIC	TABLET	120	3
33261-881-30	Hydrocodone Bitartate and Acetaminophen	30 in 1 BOTTLE, PLASTIC	TABLET	30	3
33261-881-60	Hydrocodone Bitartate and Acetaminophen	60 in 1 BOTTLE, PLASTIC	TABLET	60	3
33261-881-90	Hydrocodone Bitartate and Acetaminophen	90 in 1 BOTTLE, PLASTIC	TABLET	90	3

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	HYDROCODONE BITARTATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE, ACETAMINOPHEN) TABLET [AIDAREX PHARMACEUTICALS LLC]	2
HYDROCODONE BITARTRATE	ACTIVE INGREDIENT	NO70W886KK	HYDROCODONE BITARTATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE, ACETAMINOPHEN) TABLET [AIDAREX PHARMACEUTICALS LLC]	2
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	HYDROCODONE BITARTATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE, ACETAMINOPHEN) TABLET [AIDAREX PHARMACEUTICALS LLC]	2
HYDROCODONE	ACTIVE MOIETY	6YKS4Y3WQ7	HYDROCODONE BITARTATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE, ACETAMINOPHEN) TABLET [AIDAREX PHARMACEUTICALS LLC]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	HYDROCODONE BITARTATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE, ACETAMINOPHEN) TABLET [AIDAREX PHARMACEUTICALS LLC]	2
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	HYDROCODONE BITARTATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE, ACETAMINOPHEN) TABLET [AIDAREX PHARMACEUTICALS LLC]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	HYDROCODONE BITARTATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE, ACETAMINOPHEN) TABLET [AIDAREX PHARMACEUTICALS LLC]	2
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	HYDROCODONE BITARTATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE, ACETAMINOPHEN) TABLET [AIDAREX PHARMACEUTICALS LLC]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	HYDROCODONE BITARTATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE, ACETAMINOPHEN) TABLET [AIDAREX PHARMACEUTICALS LLC]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	HYDROCODONE BITARTATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE, ACETAMINOPHEN) TABLET [AIDAREX PHARMACEUTICALS LLC]	2
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	HYDROCODONE BITARTATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE, ACETAMINOPHEN) TABLET [AIDAREX PHARMACEUTICALS LLC]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
33261-881	HYDROCODONE BITARTATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE, ACETAMINOPHEN) TABLET [AIDAREX PHARMACEUTICALS LLC]	3	Legacy NDC, 5 package rows	20180523_03aea0d1-c808-40ae-9605-166733202166.zip

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
857391	HYDROcodone bitartrate 2.5 MG / acetaminophen 325 MG Oral Tablet	PSN	03aea0d1-c808-40ae-9605-166733202166	3
857391	acetaminophen 325 MG / hydrocodone bitartrate 2.5 MG Oral Tablet	SCD	03aea0d1-c808-40ae-9605-166733202166	3
857391	APAP 325 MG / Hydrocodone Bitartrate 2.5 MG Oral Tablet	SY	03aea0d1-c808-40ae-9605-166733202166	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
33261-881-00	33261088100	100 in 1 BOTTLE, PLASTIC	Historical
33261-881-02	33261088102	120 in 1 BOTTLE, PLASTIC	Historical
33261-881-30	33261088130	30 in 1 BOTTLE, PLASTIC	Historical
33261-881-60	33261088160	60 in 1 BOTTLE, PLASTIC	Historical
33261-881-90	33261088190	90 in 1 BOTTLE, PLASTIC	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Hydrocodone Bitartrate and Acetaminophen Tablets USP 2.5 mg/325 mg Rx only	Aidarex Pharmaceuticals LLC \| Aidarex Pharmaceuticals	2018-05-23	HUMAN PRESCRIPTION DRUG LABEL	3