Hydrocodone Bitartrate and Acetaminophen

Product NDC: 12634-616
11-digit product format: 126340616
Labeler code: 12634
Product ID: 12634-616_91924151-259e-4f6b-869c-01ba4a4729ae
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: hydrocodone bitartrate and acetaminophen
Dosage form: SOLUTION
Route: ORAL
Labeler: Apotheca, Inc
Application: ANDA040838
Marketing category: ANDA
Marketing start: 2014-03-31
Marketing end: 0000-00-00
Substance: HYDROCODONE BITARTRATE; ACETAMINOPHEN
Active strength: 8 mg/120mL; mg/120mL
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	12634-616		I	Inactivated by FDA		2026-08-11
excluded package	package	12634-616	12634-616-04	I	Inactivated by FDA		2026-08-11

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 1 · 42 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	12634-616-04	`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	12634-616-04	`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	12634-616-04	`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	12634-616-04	`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	12634-616-04	`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	12634-616-04	`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	12634-616-04	`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	12634-616-04	`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	12634-616-04	`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	12634-616-04	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	12634-616-04	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	12634-616-04	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	12634-616-04	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	12634-616-04	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	12634-616-04	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	12634-616-04	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	12634-616-04	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	12634-616-04	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	12634-616-04	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	12634-616-04	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	12634-616-04	`9bebd1f3094a…`	`5416666fcb17…`

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
A040838-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	ACETAMINOPHEN; HYDROCODONE BITARTRATE	325MG/15ML;7.5MG/15ML	SOLUTION / ORAL	AA		2013-05-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040838-001	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 2 · 41 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	A040838-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG/15ML;7.5MG/15ML	SOLUTION / ORAL	AA	2013-05-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040838-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG/15ML;7.5MG/15ML	SOLUTION / ORAL	AA	2013-05-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040838-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG/15ML;7.5MG/15ML	SOLUTION / ORAL	AA	2013-05-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040838-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG/15ML;7.5MG/15ML	SOLUTION / ORAL	AA	2013-05-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040838-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG/15ML;7.5MG/15ML	SOLUTION / ORAL	AA	2013-05-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040838-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG/15ML;7.5MG/15ML	SOLUTION / ORAL	AA	2013-05-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040838-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG/15ML;7.5MG/15ML	SOLUTION / ORAL	AA	2013-05-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040838-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG/15ML;7.5MG/15ML	SOLUTION / ORAL	AA	2013-05-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040838-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG/15ML;7.5MG/15ML	SOLUTION / ORAL	AA	2013-05-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040838-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG/15ML;7.5MG/15ML	SOLUTION / ORAL	AA	2013-05-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040838-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG/15ML;7.5MG/15ML	SOLUTION / ORAL	AA	2013-05-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040838-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG/15ML;7.5MG/15ML	SOLUTION / ORAL	AA	2013-05-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040838-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG/15ML;7.5MG/15ML	SOLUTION / ORAL	AA	2013-05-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040838-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG/15ML;7.5MG/15ML	SOLUTION / ORAL	AA	2013-05-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040838-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG/15ML;7.5MG/15ML	SOLUTION / ORAL	AA	2013-05-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040838-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG/15ML;7.5MG/15ML	SOLUTION / ORAL	AA	2013-05-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040838-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG/15ML;7.5MG/15ML	SOLUTION / ORAL	AA	2013-05-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040838-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG/15ML;7.5MG/15ML	SOLUTION / ORAL	AA	2013-05-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040838-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG/15ML;7.5MG/15ML	SOLUTION / ORAL	AA	2013-05-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040838-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG/15ML;7.5MG/15ML	SOLUTION / ORAL	AA	2013-05-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040838-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG/15ML;7.5MG/15ML	SOLUTION / ORAL	AA	2013-05-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040838-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG/15ML;7.5MG/15ML	SOLUTION / ORAL	AA	2013-05-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040838-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG/15ML;7.5MG/15ML	SOLUTION / ORAL	AA	2013-05-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040838-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG/15ML;7.5MG/15ML	SOLUTION / ORAL	AA	2013-05-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040838-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG/15ML;7.5MG/15ML	SOLUTION / ORAL	AA	2013-05-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040838-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG/15ML;7.5MG/15ML	SOLUTION / ORAL	AA	2013-05-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040838-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG/15ML;7.5MG/15ML	SOLUTION / ORAL	AA	2013-05-10	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040838-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG/15ML;7.5MG/15ML	SOLUTION / ORAL	AA	2013-05-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040838-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG/15ML;7.5MG/15ML	SOLUTION / ORAL	AA	2013-05-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040838-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG/15ML;7.5MG/15ML	SOLUTION / ORAL	AA	2013-05-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040838-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG/15ML;7.5MG/15ML	SOLUTION / ORAL	AA	2013-05-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040838-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG/15ML;7.5MG/15ML	SOLUTION / ORAL	AA	2013-05-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040838-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG/15ML;7.5MG/15ML	SOLUTION / ORAL	AA	2013-05-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040838-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG/15ML;7.5MG/15ML	SOLUTION / ORAL	AA	2013-05-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040838-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG/15ML;7.5MG/15ML	SOLUTION / ORAL	AA	2013-05-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040838-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG/15ML;7.5MG/15ML	SOLUTION / ORAL	AA	2013-05-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040838-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG/15ML;7.5MG/15ML	SOLUTION / ORAL	AA	2013-05-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040838-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG/15ML;7.5MG/15ML	SOLUTION / ORAL	AA	2013-05-10	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040838-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG/15ML;7.5MG/15ML	SOLUTION / ORAL	AA	2013-05-10	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040838-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG/15ML;7.5MG/15ML	SOLUTION / ORAL	AA	2013-05-10	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A040838-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040838-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040838-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040838-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040838-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040838-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040838-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040838-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040838-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040838-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040838-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040838-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040838-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040838-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040838-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040838-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040838-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040838-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040838-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040838-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040838-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040838-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040838-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040838-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040838-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040838-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040838-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040838-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040838-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040838-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040838-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040838-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040838-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040838-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040838-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040838-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040838-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040838-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040838-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040838-001	AA	1	`cb3db0bc1861…`

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
12634-616-04	2020-01-31	C162847	48780-1	9d75b9d0-bdb5-f424-e053-dadaa90a57ce	Hydrocodone Bitartrate & Acetaminophen Oral Solution CII

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
12634-616-04	Hydrocodone Bitartrate and Acetaminophen	120 mL in 1 BOTTLE	SOLUTION	120		2

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	HYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [APOTHECA, INC]	2
HYDROCODONE BITARTRATE	ACTIVE INGREDIENT	NO70W886KK	HYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [APOTHECA, INC]	2
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	HYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [APOTHECA, INC]	2
HYDROCODONE	ACTIVE MOIETY	6YKS4Y3WQ7	HYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [APOTHECA, INC]	2
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	HYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [APOTHECA, INC]	2
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	HYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [APOTHECA, INC]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	HYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [APOTHECA, INC]	2
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	HYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [APOTHECA, INC]	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	HYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [APOTHECA, INC]	2
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	HYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [APOTHECA, INC]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	HYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [APOTHECA, INC]	2
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	HYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [APOTHECA, INC]	2
SORBITOL	INACTIVE INGREDIENT	506T60A25R	HYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [APOTHECA, INC]	2
SUCROSE	INACTIVE INGREDIENT	C151H8M554	HYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [APOTHECA, INC]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	HYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [APOTHECA, INC]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
12634-616	HYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [APOTHECA, INC]	2	Legacy NDC, 1 package rows	20141024_fe6e60c8-53de-4b77-825d-b7427a63f54c.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 · 3 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	PAI Holdings, LLC dba PAI Pharma	c29b97e9-8097-4d87-a420-ccf5aec8274a	2026-02-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040838 application number: ANDA040838
Hydrocodone Bitartrate and Acetaminophen	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	Genus Lifesciences Inc.	a9fb9779-76a5-407a-a155-84f198004ae2	2025-07-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040838 application number: ANDA040838
Hydrocodone Bitartrate and Acetaminophen	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	Redpharm drug	1535f903-8bd0-c09e-e063-6294a90a4d4d	2025-04-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040838 application number: ANDA040838

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
12634-616-04	12634061604	120 mL in 1 BOTTLE	120 ml	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Hydrocodone Bitartrate & Acetaminophen Oral Solution CII	Apotheca, Inc	2014-10-22	HUMAN PRESCRIPTION DRUG LABEL	2