HYDROCODONE BIT/APAP

Product NDC: 45865-411
11-digit product format: 458650411
Labeler code: 45865
Product ID: 45865-411_1e13cbb2-936a-4919-e054-00144ff8d46c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Dosage form: TABLET
Route: ORAL
Labeler: Medsource Pharmaceuticals
Application: ANDA040400
Marketing category: ANDA
Marketing start: 2011-07-01
Marketing end: 0000-00-00
Substance: HYDROCODONE BITARTRATE; ACETAMINOPHEN
Active strength: 10 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 · 13 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	45865-411		I	Inactivated by FDA	2026-08-17
excluded package	package	45865-411	45865-411-06	I	Inactivated by FDA	2026-08-17
excluded package	package	45865-411	45865-411-12	I	Inactivated by FDA	2026-08-17
excluded package	package	45865-411	45865-411-15	I	Inactivated by FDA	2026-08-17
excluded package	package	45865-411	45865-411-20	I	Inactivated by FDA	2026-08-17
excluded package	package	45865-411	45865-411-30	I	Inactivated by FDA	2026-08-17
excluded package	package	45865-411	45865-411-40	I	Inactivated by FDA	2026-08-17
excluded package	package	45865-411	45865-411-49	I	Inactivated by FDA	2026-08-17
excluded package	package	45865-411	45865-411-51	I	Inactivated by FDA	2026-08-17
excluded package	package	45865-411	45865-411-52	I	Inactivated by FDA	2026-08-17
excluded package	package	45865-411	45865-411-57	I	Inactivated by FDA	2026-08-17
excluded package	package	45865-411	45865-411-59	I	Inactivated by FDA	2026-08-17
excluded package	package	45865-411	45865-411-60	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 5 · 273 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	45865-411-15	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	45865-411-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	45865-411-57	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	45865-411-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	45865-411-20	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	45865-411-51	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	45865-411-06	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	45865-411-49	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	45865-411-59	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	45865-411-52	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	45865-411-12	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	45865-411-40	`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	45865-411-15	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	45865-411-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	45865-411-57	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	45865-411-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	45865-411-20	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	45865-411-51	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	45865-411-06	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	45865-411-49	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	45865-411-59	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	45865-411-52	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	45865-411-12	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	45865-411-40	`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	45865-411-15	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	45865-411-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	45865-411-57	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	45865-411-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	45865-411-20	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	45865-411-51	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	45865-411-06	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	45865-411-49	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	45865-411-59	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	45865-411-52	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	45865-411-12	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	45865-411-40	`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	45865-411-15	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	45865-411-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	45865-411-57	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	45865-411-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	45865-411-20	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	45865-411-51	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	45865-411-06	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	45865-411-49	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	45865-411-59	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	45865-411-52	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	45865-411-12	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	45865-411-40	`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	45865-411-15	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	45865-411-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	45865-411-57	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	45865-411-60	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	45865-411-20	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	45865-411-51	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	45865-411-06	`cfe11265f3b6…`	`090c488252e2…`

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
A040400-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	ACETAMINOPHEN; HYDROCODONE BITARTRATE	325MG;10MG	TABLET / ORAL	AA	RS	2000-07-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040400-001	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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A040400-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	RS	2000-07-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040400-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	RS	2000-07-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040400-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	RS	2000-07-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040400-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	RS	2000-07-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040400-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	RS	2000-07-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040400-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	RS	2000-07-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040400-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	RS	2000-07-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040400-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	RS	2000-07-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040400-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	RS	2000-07-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040400-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	RS	2000-07-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040400-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	RS	2000-07-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040400-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	RS	2000-07-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040400-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	RS	2000-07-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040400-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	RS	2000-07-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040400-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	RS	2000-07-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040400-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	RS	2000-07-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040400-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	RS	2000-07-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040400-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	RS	2000-07-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040400-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA		2000-07-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040400-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	RS	2000-07-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040400-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	RS	2000-07-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040400-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA		2000-07-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040400-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA		2000-07-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040400-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA		2000-07-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040400-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA		2000-07-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040400-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA		2000-07-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040400-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA		2000-07-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040400-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA		2000-07-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040400-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	RS	2000-07-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040400-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	RS	2000-07-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040400-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	RS	2000-07-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040400-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	RS	2000-07-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040400-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	RS	2000-07-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040400-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	RS	2000-07-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040400-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	RS	2000-07-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040400-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	RS	2000-07-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040400-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	RS	2000-07-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040400-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	RS	2000-07-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040400-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	RS	2000-07-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040400-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	RS	2000-07-26	`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	A040400-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040400-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040400-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040400-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040400-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040400-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040400-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040400-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040400-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040400-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040400-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040400-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040400-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040400-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040400-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040400-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040400-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040400-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040400-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040400-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040400-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040400-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040400-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040400-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040400-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040400-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040400-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040400-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040400-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040400-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040400-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040400-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040400-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040400-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040400-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040400-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040400-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040400-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040400-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040400-001	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
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
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
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
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
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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
45865-411-06	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS USP CIII
45865-411-12	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS USP CIII
45865-411-15	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS USP CIII
45865-411-20	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS USP CIII
45865-411-30	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS USP CIII
45865-411-40	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS USP CIII
45865-411-49	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS USP CIII
45865-411-51	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS USP CIII
45865-411-52	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS USP CIII
45865-411-57	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS USP CIII
45865-411-59	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS USP CIII
45865-411-60	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS USP CIII

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
45865-411-06	HYDROCODONE BIT/APAP	6 in 1 BOTTLE	TABLET	6	5
45865-411-12	HYDROCODONE BIT/APAP	12 in 1 BOTTLE	TABLET	12	5
45865-411-15	HYDROCODONE BIT/APAP	15 in 1 BOTTLE	TABLET	15	5
45865-411-20	HYDROCODONE BIT/APAP	20 in 1 BOTTLE	TABLET	20	5
45865-411-30	HYDROCODONE BIT/APAP	30 in 1 BOTTLE	TABLET	30	5
45865-411-40	HYDROCODONE BIT/APAP	40 in 1 BOTTLE	TABLET	40	5
45865-411-49	HYDROCODONE BIT/APAP	100 in 1 BOTTLE	TABLET	100	5
45865-411-51	HYDROCODONE BIT/APAP	120 in 1 BOTTLE	TABLET	120	5
45865-411-52	HYDROCODONE BIT/APAP	126 in 1 BOTTLE	TABLET	126	5
45865-411-57	HYDROCODONE BIT/APAP	180 in 1 BOTTLE	TABLET	180	5
45865-411-59	HYDROCODONE BIT/APAP	252 in 1 BOTTLE	TABLET	252	5
45865-411-60	HYDROCODONE BIT/APAP	60 in 1 BOTTLE	TABLET	60	5

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	HYDROCODONE BIT/APAP (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) TABLET [MEDSOURCE PHARMACEUTICALS]	5
HYDROCODONE BITARTRATE	ACTIVE INGREDIENT	NO70W886KK	HYDROCODONE BIT/APAP (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) TABLET [MEDSOURCE PHARMACEUTICALS]	5
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	HYDROCODONE BIT/APAP (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) TABLET [MEDSOURCE PHARMACEUTICALS]	5
HYDROCODONE	ACTIVE MOIETY	6YKS4Y3WQ7	HYDROCODONE BIT/APAP (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) TABLET [MEDSOURCE PHARMACEUTICALS]	5
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	HYDROCODONE BIT/APAP (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) TABLET [MEDSOURCE PHARMACEUTICALS]	5
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	HYDROCODONE BIT/APAP (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) TABLET [MEDSOURCE PHARMACEUTICALS]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	HYDROCODONE BIT/APAP (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) TABLET [MEDSOURCE PHARMACEUTICALS]	5
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	HYDROCODONE BIT/APAP (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) TABLET [MEDSOURCE PHARMACEUTICALS]	5
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	HYDROCODONE BIT/APAP (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) TABLET [MEDSOURCE PHARMACEUTICALS]	5
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	HYDROCODONE BIT/APAP (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) TABLET [MEDSOURCE PHARMACEUTICALS]	5
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	HYDROCODONE BIT/APAP (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) TABLET [MEDSOURCE PHARMACEUTICALS]	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
45865-411	HYDROCODONE BIT/APAP (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) TABLET [MEDSOURCE PHARMACEUTICALS]	5	Legacy NDC, 12 package rows	20150825_53b3ed76-db40-4aa8-8c55-21991d557b42.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 · 6 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	ST. MARY'S MEDICAL PARK PHARMACY	3d342071-7fdd-d899-e063-6294a90ae782	2026-05-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040400 application number: ANDA040400
HYDROCODONE BITARTRATE AND ACETAMINOPHEN	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	SpecGx LLC	73c1059b-0c7d-42ef-9827-f018858fc447	2026-04-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040400 application number: ANDA040400
Norco	HYDROCODONE/APAP	Direct_Rx	ee248dfd-7aa7-7dcc-e053-2995a90af19f	2025-01-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040400 application number: ANDA040400
HYDROCODONE BITARTRATE AND ACETAMINOPHEN	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	Quality Care Products, LLC	e7d36246-9c80-49b6-ad4b-e38c3fd6d068	2024-12-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040400 application number: ANDA040400
HYDROCODONE BITARTRATE AND ACETAMINOPHEN	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	Golden State Medical Supply, Inc.	87ed3420-1697-6f42-e053-2995a90a1a5b	2024-12-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040400 application number: ANDA040400
HYDROCODONE BITARTRATE AND ACETAMINOPHEN	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	Proficient Rx LP	62dd3c7a-4150-44a2-b05b-bc31308f2200	2023-08-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040400 application number: ANDA040400

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
856999	HYDROcodone bitartrate 10 MG / acetaminophen 325 MG Oral Tablet	PSN	53b3ed76-db40-4aa8-8c55-21991d557b42	5
856999	acetaminophen 325 MG / hydrocodone bitartrate 10 MG Oral Tablet	SCD	53b3ed76-db40-4aa8-8c55-21991d557b42	5
856999	APAP 325 MG / hydrocodone bitartrate 10 MG Oral Tablet	SY	53b3ed76-db40-4aa8-8c55-21991d557b42	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
45865-411-06	45865041106	6 in 1 BOTTLE	Historical
45865-411-12	45865041112	12 in 1 BOTTLE	Historical
45865-411-15	45865041115	15 in 1 BOTTLE	Historical
45865-411-20	45865041120	20 in 1 BOTTLE	Historical
45865-411-30	45865041130	30 in 1 BOTTLE	Historical
45865-411-40	45865041140	40 in 1 BOTTLE	Historical
45865-411-49	45865041149	100 in 1 BOTTLE	Historical
45865-411-51	45865041151	120 in 1 BOTTLE	Historical
45865-411-52	45865041152	126 in 1 BOTTLE	Historical
45865-411-57	45865041157	180 in 1 BOTTLE	Historical
45865-411-59	45865041159	252 in 1 BOTTLE	Historical
45865-411-60	45865041160	60 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS USP CIII	Medsource Pharmaceuticals	2015-08-24	HUMAN PRESCRIPTION DRUG LABEL	5