Hydrocodone Bitartrate and Acetaminophen

Product NDC: 64376-640
11-digit product format: 643760640
Labeler code: 64376
Product ID: 64376-640_5a130fa6-bcb0-4363-92a0-f657afc557ee
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Hydrocodone Bitartrate, Acetaminophen
Dosage form: SOLUTION
Route: ORAL
Labeler: Par Pharmaceutical
Application: ANDA040894
Marketing category: ANDA
Marketing start: 2011-07-27
Marketing end: 2021-09-30
Substance: ACETAMINOPHEN; HYDROCODONE BITARTRATE
Active strength: 325 mg/15mL; mg/15mL
Pharmacologic classes: Opioid Agonist [EPC],Opioid Agonists [MoA]
DEA schedule: CII
NDC exclude flag: No
Listing certified through: 0000-00-00
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	64376-640		D	Discontinued by firm	2026-08-17
excluded package	package	64376-640	64376-640-16	D	Discontinued by firm	2026-08-17
excluded package	package	64376-640	64376-640-40	D	Discontinued by firm	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 1 · 36 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	64376-640-40	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	64376-640-16	`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	64376-640-40	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	64376-640-16	`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	64376-640-40	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	64376-640-16	`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	64376-640-40	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	64376-640-16	`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	64376-640-40	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	64376-640-16	`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	64376-640-40	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	64376-640-16	`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	64376-640-40	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	64376-640-16	`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	64376-640-40	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	64376-640-16	`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	64376-640-40	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	64376-640-16	`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	64376-640-40	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	64376-640-16	`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	64376-640-40	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	64376-640-16	`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	64376-640-40	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	64376-640-16	`557ba5c1ecfa…`	`9c80585c8c6e…`

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

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
A040894-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	ACETAMINOPHEN; HYDROCODONE BITARTRATE	325MG/15ML;7.5MG/15ML	SOLUTION / ORAL	AA		2011-07-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040894-001	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 · 42 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	A040894-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG/15ML;7.5MG/15ML	SOLUTION / ORAL	AA	2011-07-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040894-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG/15ML;7.5MG/15ML	SOLUTION / ORAL	AA	2011-07-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040894-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG/15ML;7.5MG/15ML	SOLUTION / ORAL	AA	2011-07-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040894-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG/15ML;7.5MG/15ML	SOLUTION / ORAL	AA	2011-07-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040894-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG/15ML;7.5MG/15ML	SOLUTION / ORAL	AA	2011-07-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040894-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG/15ML;7.5MG/15ML	SOLUTION / ORAL	AA	2011-07-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040894-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG/15ML;7.5MG/15ML	SOLUTION / ORAL	AA	2011-07-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040894-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG/15ML;7.5MG/15ML	SOLUTION / ORAL	AA	2011-07-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040894-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG/15ML;7.5MG/15ML	SOLUTION / ORAL	AA	2011-07-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040894-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG/15ML;7.5MG/15ML	SOLUTION / ORAL	AA	2011-07-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040894-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG/15ML;7.5MG/15ML	SOLUTION / ORAL	AA	2011-07-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040894-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG/15ML;7.5MG/15ML	SOLUTION / ORAL	AA	2011-07-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040894-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG/15ML;7.5MG/15ML	SOLUTION / ORAL	AA	2011-07-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040894-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG/15ML;7.5MG/15ML	SOLUTION / ORAL	AA	2011-07-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040894-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG/15ML;7.5MG/15ML	SOLUTION / ORAL	AA	2011-07-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040894-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG/15ML;7.5MG/15ML	SOLUTION / ORAL	AA	2011-07-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040894-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG/15ML;7.5MG/15ML	SOLUTION / ORAL	AA	2011-07-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040894-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG/15ML;7.5MG/15ML	SOLUTION / ORAL	AA	2011-07-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040894-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG/15ML;7.5MG/15ML	SOLUTION / ORAL	AA	2011-07-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040894-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG/15ML;7.5MG/15ML	SOLUTION / ORAL	AA	2011-07-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040894-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG/15ML;7.5MG/15ML	SOLUTION / ORAL	AA	2011-07-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040894-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG/15ML;7.5MG/15ML	SOLUTION / ORAL	AA	2011-07-19	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040894-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG/15ML;7.5MG/15ML	SOLUTION / ORAL	AA	2011-07-19	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040894-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG/15ML;7.5MG/15ML	SOLUTION / ORAL	AA	2011-07-19	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040894-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG/15ML;7.5MG/15ML	SOLUTION / ORAL	AA	2011-07-19	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040894-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG/15ML;7.5MG/15ML	SOLUTION / ORAL	AA	2011-07-19	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040894-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG/15ML;7.5MG/15ML	SOLUTION / ORAL	AA	2011-07-19	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040894-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG/15ML;7.5MG/15ML	SOLUTION / ORAL	AA	2011-07-19	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040894-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG/15ML;7.5MG/15ML	SOLUTION / ORAL	AA	2011-07-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040894-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG/15ML;7.5MG/15ML	SOLUTION / ORAL	AA	2011-07-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040894-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG/15ML;7.5MG/15ML	SOLUTION / ORAL	AA	2011-07-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040894-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG/15ML;7.5MG/15ML	SOLUTION / ORAL	AA	2011-07-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040894-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG/15ML;7.5MG/15ML	SOLUTION / ORAL	AA	2011-07-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040894-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG/15ML;7.5MG/15ML	SOLUTION / ORAL	AA	2011-07-19	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040894-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG/15ML;7.5MG/15ML	SOLUTION / ORAL	AA	2011-07-19	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040894-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG/15ML;7.5MG/15ML	SOLUTION / ORAL	AA	2011-07-19	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040894-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG/15ML;7.5MG/15ML	SOLUTION / ORAL	AA	2011-07-19	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040894-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG/15ML;7.5MG/15ML	SOLUTION / ORAL	AA	2011-07-19	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040894-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG/15ML;7.5MG/15ML	SOLUTION / ORAL	AA	2011-07-19	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040894-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG/15ML;7.5MG/15ML	SOLUTION / ORAL	AA	2011-07-19	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 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	A040894-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040894-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040894-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040894-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040894-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040894-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040894-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040894-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040894-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040894-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040894-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040894-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040894-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040894-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040894-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040894-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040894-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040894-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040894-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040894-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040894-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040894-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040894-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040894-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040894-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040894-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040894-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040894-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040894-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040894-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040894-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040894-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040894-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040894-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040894-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040894-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040894-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040894-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040894-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040894-001	AA	1	`e64feba35796…`

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
16cde546-8deb-4df2-a072-dab5566ede95	Product name	1	20231003
20ab58de-c64a-4ec2-9210-3aa3fae2b66f	Product name	1	20230808
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
a3631b20-02d1-41d7-8187-5e5e850b9e80	Product name	1	20230306
79e1734e-f721-4d46-978a-be382f771672	Product name	2	20230110
41b814f3-0166-1c53-c9ef-a0794c7daf9d	Product name	3	20221110
a590be26-846c-8659-a5a1-fb25907965dc	Product name	2	20221110
06cc817f-60e0-4473-8e6b-c44d11dc5af6	Product name	9	20220921
92ead9ae-674d-4eee-a492-c385d496891f	Product name	3	20220308
53523715-c529-4d52-b9ff-1e5d76636f53	Product name	2	20210818
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
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
20c8cafe-5cfc-44f8-a9be-a664f437f780	Product name	2	20200225
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
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
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
377068df-225f-7318-a910-a1987cdfa361	Product name	3	20170608
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
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
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
23475c0b-a5b5-4fec-b97f-acca901eae6a	Product name	1	20140718
105ef617-6fa4-6713-326f-72ec8a6b75a9	Product name	1	20140508
332e86c3-7875-ca6e-f934-2206d2b31996	Product name	1	20140508
3ed6b849-48b8-8899-c288-6eeb396123b6	Product name	1	20140508
47fd879b-91c5-e1e5-130f-29d082a871ec	Product name	1	20140508
53855190-7124-8179-f018-e792f7c27f28	Product name	1	20140508
6084a4f4-5437-c9a5-caec-5361ee075a59	Product name	1	20140508
61c18d4e-b552-5478-8fc0-df38b93e3100	Product name	1	20140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092	Product name	1	20140508
84fb0b3d-1d72-b672-bc70-2b676a23e7e0	Product name	1	20140508
90c5639a-61b0-88d6-ddcf-21888e94869a	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
96c5169b-5b9d-547d-bf22-d688d91866e4	Product name	1	20140508
b8e0daf1-fb81-290b-c0bf-873be19ef775	Product name	1	20140508
c35d1ac8-8885-2ee1-6c52-5a715b242c00	Product name	1	20140508
c8753a88-edde-8e17-a396-705537b52cee	Product name	1	20140508
cd4f9ae2-1343-ecd2-ce0f-97db0c2b51ce	Product name	1	20140508
cf3a804d-0326-aa22-0142-c184b5657d85	Product name	1	20140508
d83c592c-dd97-4cbf-36ac-13da806684bd	Product name	1	20140508
e01133ad-4dcd-c7f3-454b-2ff569ee160a	Product name	1	20140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
64376-640-16	ML - Milliliter	64376-640	08b15b0c-0d5a-4929-837e-14869bf714d9	1	2012-07-24
64376-640-40	ML - Milliliter	64376-640	fdf0f1e7-888e-4833-852a-2bc1af9dc121	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE, ACETAMINOPHEN) SOLUTION [BOCA PHARMACAL, LLC]	5
HYDROCODONE BITARTRATE	ACTIVE INGREDIENT	NO70W886KK	HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE, ACETAMINOPHEN) SOLUTION [BOCA PHARMACAL, LLC]	5
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE, ACETAMINOPHEN) SOLUTION [BOCA PHARMACAL, LLC]	5
HYDROCODONE	ACTIVE MOIETY	6YKS4Y3WQ7	HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE, ACETAMINOPHEN) SOLUTION [BOCA PHARMACAL, LLC]	5
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE, ACETAMINOPHEN) SOLUTION [BOCA PHARMACAL, LLC]	5
D&C RED NO. 33	INACTIVE INGREDIENT	9DBA0SBB0L	HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE, ACETAMINOPHEN) SOLUTION [BOCA PHARMACAL, LLC]	5
ETHYL MALTOL	INACTIVE INGREDIENT	L6Q8K29L05	HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE, ACETAMINOPHEN) SOLUTION [BOCA PHARMACAL, LLC]	5
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE, ACETAMINOPHEN) SOLUTION [BOCA PHARMACAL, LLC]	5
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE, ACETAMINOPHEN) SOLUTION [BOCA PHARMACAL, LLC]	5
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE, ACETAMINOPHEN) SOLUTION [BOCA PHARMACAL, LLC]	5
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE, ACETAMINOPHEN) SOLUTION [BOCA PHARMACAL, LLC]	5
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE, ACETAMINOPHEN) SOLUTION [BOCA PHARMACAL, LLC]	5
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE, ACETAMINOPHEN) SOLUTION [BOCA PHARMACAL, LLC]	5
SORBITOL	INACTIVE INGREDIENT	506T60A25R	HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE, ACETAMINOPHEN) SOLUTION [BOCA PHARMACAL, LLC]	5
SUCROSE	INACTIVE INGREDIENT	C151H8M554	HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE, ACETAMINOPHEN) SOLUTION [BOCA PHARMACAL, LLC]	5
WATER	INACTIVE INGREDIENT	059QF0KO0R	HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE, ACETAMINOPHEN) SOLUTION [BOCA PHARMACAL, LLC]	5
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE, ACETAMINOPHEN) SOLUTION [ATLANTIC BIOLOGICALS CORPS]	4
HYDROCODONE BITARTRATE	ACTIVE INGREDIENT	NO70W886KK	HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE, ACETAMINOPHEN) SOLUTION [ATLANTIC BIOLOGICALS CORPS]	4
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE, ACETAMINOPHEN) SOLUTION [ATLANTIC BIOLOGICALS CORPS]	4
HYDROCODONE	ACTIVE MOIETY	6YKS4Y3WQ7	HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE, ACETAMINOPHEN) SOLUTION [ATLANTIC BIOLOGICALS CORPS]	4
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE, ACETAMINOPHEN) SOLUTION [ATLANTIC BIOLOGICALS CORPS]	4
D&C RED NO. 33	INACTIVE INGREDIENT	9DBA0SBB0L	HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE, ACETAMINOPHEN) SOLUTION [ATLANTIC BIOLOGICALS CORPS]	4
ETHYL MALTOL	INACTIVE INGREDIENT	L6Q8K29L05	HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE, ACETAMINOPHEN) SOLUTION [ATLANTIC BIOLOGICALS CORPS]	4
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE, ACETAMINOPHEN) SOLUTION [ATLANTIC BIOLOGICALS CORPS]	4
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE, ACETAMINOPHEN) SOLUTION [ATLANTIC BIOLOGICALS CORPS]	4
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE, ACETAMINOPHEN) SOLUTION [ATLANTIC BIOLOGICALS CORPS]	4
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE, ACETAMINOPHEN) SOLUTION [ATLANTIC BIOLOGICALS CORPS]	4
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE, ACETAMINOPHEN) SOLUTION [ATLANTIC BIOLOGICALS CORPS]	4
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE, ACETAMINOPHEN) SOLUTION [ATLANTIC BIOLOGICALS CORPS]	4
SORBITOL	INACTIVE INGREDIENT	506T60A25R	HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE, ACETAMINOPHEN) SOLUTION [ATLANTIC BIOLOGICALS CORPS]	4
SUCROSE	INACTIVE INGREDIENT	C151H8M554	HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE, ACETAMINOPHEN) SOLUTION [ATLANTIC BIOLOGICALS CORPS]	4
WATER	INACTIVE INGREDIENT	059QF0KO0R	HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE, ACETAMINOPHEN) SOLUTION [ATLANTIC BIOLOGICALS CORPS]	4
Acetaminophen	ACTIVE INGREDIENT	362O9ITL9D	HYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [PRECISION DOSE INC.]	2
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE, ACETAMINOPHEN) SOLUTION [PHYSICIANS TOTAL CARE, INC.]	2
Hydrocodone Bitartrate	ACTIVE INGREDIENT	NO70W886KK	HYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [PRECISION DOSE INC.]	2
HYDROCODONE BITARTRATE	ACTIVE INGREDIENT	NO70W886KK	HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE, ACETAMINOPHEN) SOLUTION [PHYSICIANS TOTAL CARE, INC.]	2
Acetaminophen	ACTIVE MOIETY	362O9ITL9D	HYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [PRECISION DOSE INC.]	2
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE, ACETAMINOPHEN) SOLUTION [PHYSICIANS TOTAL CARE, INC.]	2
Hydrocodone	ACTIVE MOIETY	6YKS4Y3WQ7	HYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [PRECISION DOSE INC.]	2
HYDROCODONE	ACTIVE MOIETY	6YKS4Y3WQ7	HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE, ACETAMINOPHEN) SOLUTION [PHYSICIANS TOTAL CARE, INC.]	2
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE, ACETAMINOPHEN) SOLUTION [PHYSICIANS TOTAL CARE, INC.]	2
anhydrous citric acid	INACTIVE INGREDIENT	XF417D3PSL	HYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [PRECISION DOSE INC.]	2
D&C Red No. 33	INACTIVE INGREDIENT	9DBA0SBB0L	HYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [PRECISION DOSE INC.]	2
D&C RED NO. 33	INACTIVE INGREDIENT	9DBA0SBB0L	HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE, ACETAMINOPHEN) SOLUTION [PHYSICIANS TOTAL CARE, INC.]	2
ETHYL MALTOL	INACTIVE INGREDIENT	L6Q8K29L05	HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE, ACETAMINOPHEN) SOLUTION [PHYSICIANS TOTAL CARE, INC.]	2
ethyl maltol	INACTIVE INGREDIENT	L6Q8K29L05	HYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [PRECISION DOSE INC.]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE, ACETAMINOPHEN) SOLUTION [PHYSICIANS TOTAL CARE, INC.]	2
FD&C Red No. 40	INACTIVE INGREDIENT	WZB9127XOA	HYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [PRECISION DOSE INC.]	2
glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	HYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [PRECISION DOSE INC.]	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE, ACETAMINOPHEN) SOLUTION [PHYSICIANS TOTAL CARE, INC.]	2
methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	HYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [PRECISION DOSE INC.]	2
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE, ACETAMINOPHEN) SOLUTION [PHYSICIANS TOTAL CARE, INC.]	2
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	HYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [PRECISION DOSE INC.]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE, ACETAMINOPHEN) SOLUTION [PHYSICIANS TOTAL CARE, INC.]	2
propylparaben	INACTIVE INGREDIENT	Z8IX2SC1OH	HYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [PRECISION DOSE INC.]	2
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE, ACETAMINOPHEN) SOLUTION [PHYSICIANS TOTAL CARE, INC.]	2
saccharin sodium	INACTIVE INGREDIENT	SB8ZUX40TY	HYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [PRECISION DOSE INC.]	2
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE, ACETAMINOPHEN) SOLUTION [PHYSICIANS TOTAL CARE, INC.]	2
SORBITOL	INACTIVE INGREDIENT	506T60A25R	HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE, ACETAMINOPHEN) SOLUTION [PHYSICIANS TOTAL CARE, INC.]	2
sorbitol	INACTIVE INGREDIENT	506T60A25R	HYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [PRECISION DOSE INC.]	2
SUCROSE	INACTIVE INGREDIENT	C151H8M554	HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE, ACETAMINOPHEN) SOLUTION [PHYSICIANS TOTAL CARE, INC.]	2
sucrose	INACTIVE INGREDIENT	C151H8M554	HYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [PRECISION DOSE INC.]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE, ACETAMINOPHEN) SOLUTION [PHYSICIANS TOTAL CARE, INC.]	2
water	INACTIVE INGREDIENT	059QF0KO0R	HYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [PRECISION DOSE INC.]	2

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 · 1 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	Genus Lifesciences Inc.	26242cd7-1dbe-4ca4-88ca-5b98a6566ff9	2026-02-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040894 application number: ANDA040894

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
856940	HYDROcodone bitartrate 7.5 MG / acetaminophen 325 MG in 15 mL Oral Solution	PSN	21539e8e-a9b9-49ab-9134-c2cdc0a54321	4
856940	acetaminophen 21.7 MG/ML / hydrocodone bitartrate 0.5 MG/ML Oral Solution	SCD	21539e8e-a9b9-49ab-9134-c2cdc0a54321	4
856940	acetaminophen 108 MG / hydrocodone bitartrate 2.5 MG per 5 ML Oral Solution	SY	21539e8e-a9b9-49ab-9134-c2cdc0a54321	4
856940	acetaminophen 217 MG / hydrocodone bitartrate 5 MG per 10 ML Oral Solution	SY	21539e8e-a9b9-49ab-9134-c2cdc0a54321	4
856940	acetaminophen 325 MG / hydrocodone bitartrate 7.5 MG per 15 ML Oral Solution	SY	21539e8e-a9b9-49ab-9134-c2cdc0a54321	4
856940	APAP 21.7 MG/ML / Hydrocodone Bitartrate 0.5 MG/ML Oral Solution	SY	21539e8e-a9b9-49ab-9134-c2cdc0a54321	4
856940	HYDROcodone bitartrate 7.5 MG / acetaminophen 325 MG in 15 mL Oral Solution	PSN	e1580b70-08ad-4167-95ed-aa556ea8553e	2
856940	acetaminophen 21.7 MG/ML / hydrocodone bitartrate 0.5 MG/ML Oral Solution	SCD	e1580b70-08ad-4167-95ed-aa556ea8553e	2
856940	acetaminophen 108 MG / hydrocodone bitartrate 2.5 MG per 5 ML Oral Solution	SY	e1580b70-08ad-4167-95ed-aa556ea8553e	2
856940	acetaminophen 217 MG / hydrocodone bitartrate 5 MG per 10 ML Oral Solution	SY	e1580b70-08ad-4167-95ed-aa556ea8553e	2
856940	acetaminophen 325 MG / hydrocodone bitartrate 7.5 MG per 15 ML Oral Solution	SY	e1580b70-08ad-4167-95ed-aa556ea8553e	2
856940	APAP 21.7 MG/ML / Hydrocodone Bitartrate 0.5 MG/ML Oral Solution	SY	e1580b70-08ad-4167-95ed-aa556ea8553e	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
64376-640-16	64376064016	473 mL in 1 BOTTLE (64376-640-16)	473 ml	2011-07-27	2021-09-30	No	No	Current
64376-640-40	64376064040	118 mL in 1 BOTTLE (64376-640-40)	118 ml	2011-07-27	2021-09-30	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Hydrocodone Bitartrate and Acetaminophen Oral Solution (7.5 mg/325 mg per 15 mL) CII	Precision Dose Inc.	2019-04-01	HUMAN PRESCRIPTION DRUG LABEL	4
Hydrocodone Bitartrate and Acetaminophen Oral Solution (7.5 mg/325 mg per 15 mL) CII Rx only	Par Pharmaceutical \| Halo Pharmaceutical Inc \| Sovereign Pharmaceuticals, LLC	2018-07-27	HUMAN PRESCRIPTION DRUG LABEL	16
Hydrocodone Bitartrate and Acetaminophen Oral Solution (7.5 mg/325 mg per 15 mL)	Atlantic Biologicals Corps	2015-07-13	HUMAN PRESCRIPTION DRUG LABEL	4
Hydrocodone Bitartrate and Acetaminophen Oral Solution (7.5 mg/325 mg per 15 mL)	Physicians Total Care, Inc.	2014-10-23	HUMAN PRESCRIPTION DRUG LABEL	2