HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product NDC: 42549-557
11-digit product format: 425490557
Labeler code: 42549
Product ID: 42549-557_fe5ba386-ea2e-4884-9ce7-f00f71d4c101
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Dosage form: TABLET
Route: ORAL
Labeler: STAT Rx USA LLC
Application: ANDA040405
Marketing category: ANDA
Marketing start: 2010-04-22
Marketing end: 0000-00-00
Substance: HYDROCODONE BITARTRATE; ACETAMINOPHEN
Active strength: 8 mg/1; mg/1
Pharmacologic classes: Opioid Agonist [EPC],Opioid Agonists [MoA]
DEA schedule: CIII
NDC exclude flag: E
Listing certified through: 2017-12-31
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 · 11 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	42549-557		I	Inactivated by FDA	2026-08-11
excluded package	package	42549-557	42549-557-02	I	Inactivated by FDA	2026-08-11
excluded package	package	42549-557	42549-557-04	I	Inactivated by FDA	2026-08-11
excluded package	package	42549-557	42549-557-12	I	Inactivated by FDA	2026-08-11
excluded package	package	42549-557	42549-557-28	I	Inactivated by FDA	2026-08-11
excluded package	package	42549-557	42549-557-30	I	Inactivated by FDA	2026-08-11
excluded package	package	42549-557	42549-557-40	I	Inactivated by FDA	2026-08-11
excluded package	package	42549-557	42549-557-56	I	Inactivated by FDA	2026-08-11
excluded package	package	42549-557	42549-557-60	I	Inactivated by FDA	2026-08-11
excluded package	package	42549-557	42549-557-84	I	Inactivated by FDA	2026-08-11
excluded package	package	42549-557	42549-557-90	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 5 · 242 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	42549-557-40	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	42549-557-28	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	42549-557-90	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	42549-557-12	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	42549-557-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	42549-557-56	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	42549-557-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	42549-557-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	42549-557-84	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	42549-557-30	`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	42549-557-40	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	42549-557-28	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	42549-557-90	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	42549-557-12	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	42549-557-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	42549-557-56	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	42549-557-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	42549-557-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	42549-557-84	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	42549-557-30	`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	42549-557-40	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	42549-557-28	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	42549-557-90	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	42549-557-12	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	42549-557-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	42549-557-56	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	42549-557-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	42549-557-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	42549-557-84	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	42549-557-30	`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	42549-557-40	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	42549-557-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	42549-557-90	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	42549-557-12	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	42549-557-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	42549-557-56	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	42549-557-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	42549-557-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	42549-557-84	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	42549-557-30	`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	42549-557-40	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	42549-557-28	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	42549-557-90	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	42549-557-12	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	42549-557-60	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	42549-557-56	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	42549-557-04	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	42549-557-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	42549-557-84	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	42549-557-30	`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	42549-557-40	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	42549-557-28	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	42549-557-90	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	42549-557-12	`cdf11ea48f46…`	`ba0047e9e063…`

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
A040405-001	ANEXSIA 7.5/325	ACETAMINOPHEN; HYDROCODONE BITARTRATE	325MG;7.5MG	TABLET / ORAL	AA	RS	2000-09-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040405-001	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A040405-001	ANEXSIA 7.5/325	325MG;7.5MG	TABLET / ORAL	AA	RS	2000-09-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040405-001	ANEXSIA 7.5/325	325MG;7.5MG	TABLET / ORAL	AA	RS	2000-09-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040405-001	ANEXSIA 7.5/325	325MG;7.5MG	TABLET / ORAL	AA	RS	2000-09-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040405-001	ANEXSIA 7.5/325	325MG;7.5MG	TABLET / ORAL	AA	RS	2000-09-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040405-001	ANEXSIA 7.5/325	325MG;7.5MG	TABLET / ORAL	AA	RS	2000-09-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040405-001	ANEXSIA 7.5/325	325MG;7.5MG	TABLET / ORAL	AA	RS	2000-09-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040405-001	ANEXSIA 7.5/325	325MG;7.5MG	TABLET / ORAL	AA	RS	2000-09-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040405-001	ANEXSIA 7.5/325	325MG;7.5MG	TABLET / ORAL	AA	RS	2000-09-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040405-001	ANEXSIA 7.5/325	325MG;7.5MG	TABLET / ORAL	AA	RS	2000-09-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040405-001	ANEXSIA 7.5/325	325MG;7.5MG	TABLET / ORAL	AA	RS	2000-09-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040405-001	ANEXSIA 7.5/325	325MG;7.5MG	TABLET / ORAL	AA	RS	2000-09-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040405-001	ANEXSIA 7.5/325	325MG;7.5MG	TABLET / ORAL	AA	RS	2000-09-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040405-001	ANEXSIA 7.5/325	325MG;7.5MG	TABLET / ORAL	AA	RS	2000-09-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040405-001	ANEXSIA 7.5/325	325MG;7.5MG	TABLET / ORAL	AA	RS	2000-09-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040405-001	ANEXSIA 7.5/325	325MG;7.5MG	TABLET / ORAL	AA	RS	2000-09-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040405-001	ANEXSIA 7.5/325	325MG;7.5MG	TABLET / ORAL	AA	RS	2000-09-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040405-001	ANEXSIA 7.5/325	325MG;7.5MG	TABLET / ORAL	AA	RS	2000-09-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040405-001	ANEXSIA 7.5/325	325MG;7.5MG	TABLET / ORAL	AA		2000-09-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040405-001	ANEXSIA 7.5/325	325MG;7.5MG	TABLET / ORAL	AA	RS	2000-09-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040405-001	ANEXSIA 7.5/325	325MG;7.5MG	TABLET / ORAL	AA	RS	2000-09-08	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040405-001	ANEXSIA 7.5/325	325MG;7.5MG	TABLET / ORAL	AA		2000-09-08	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040405-001	ANEXSIA 7.5/325	325MG;7.5MG	TABLET / ORAL	AA		2000-09-08	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040405-001	ANEXSIA 7.5/325	325MG;7.5MG	TABLET / ORAL	AA		2000-09-08	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040405-001	ANEXSIA 7.5/325	325MG;7.5MG	TABLET / ORAL	AA		2000-09-08	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040405-001	ANEXSIA 7.5/325	325MG;7.5MG	TABLET / ORAL	AA		2000-09-08	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040405-001	ANEXSIA 7.5/325	325MG;7.5MG	TABLET / ORAL	AA		2000-09-08	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040405-001	ANEXSIA 7.5/325	325MG;7.5MG	TABLET / ORAL	AA		2000-09-08	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040405-001	ANEXSIA 7.5/325	325MG;7.5MG	TABLET / ORAL	AA	RS	2000-09-08	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040405-001	ANEXSIA 7.5/325	325MG;7.5MG	TABLET / ORAL	AA	RS	2000-09-08	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040405-001	ANEXSIA 7.5/325	325MG;7.5MG	TABLET / ORAL	AA	RS	2000-09-08	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040405-001	ANEXSIA 7.5/325	325MG;7.5MG	TABLET / ORAL	AA	RS	2000-09-08	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040405-001	ANEXSIA 7.5/325	325MG;7.5MG	TABLET / ORAL	AA	RS	2000-09-08	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040405-001	ANEXSIA 7.5/325	325MG;7.5MG	TABLET / ORAL	AA	RS	2000-09-08	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040405-001	ANEXSIA 7.5/325	325MG;7.5MG	TABLET / ORAL	AA	RS	2000-09-08	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040405-001	ANEXSIA 7.5/325	325MG;7.5MG	TABLET / ORAL	AA	RS	2000-09-08	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040405-001	ANEXSIA 7.5/325	325MG;7.5MG	TABLET / ORAL	AA	RS	2000-09-08	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040405-001	ANEXSIA 7.5/325	325MG;7.5MG	TABLET / ORAL	AA	RS	2000-09-08	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040405-001	ANEXSIA 7.5/325	325MG;7.5MG	TABLET / ORAL	AA	RS	2000-09-08	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040405-001	ANEXSIA 7.5/325	325MG;7.5MG	TABLET / ORAL	AA	RS	2000-09-08	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040405-001	ANEXSIA 7.5/325	325MG;7.5MG	TABLET / ORAL	AA	RS	2000-09-08	`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	A040405-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040405-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040405-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040405-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040405-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040405-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040405-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040405-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040405-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040405-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040405-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040405-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040405-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040405-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040405-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040405-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040405-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040405-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040405-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040405-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040405-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040405-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040405-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040405-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040405-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040405-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040405-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040405-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040405-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040405-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040405-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040405-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040405-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040405-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040405-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040405-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040405-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040405-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040405-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040405-001	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, Related label table
NDC	Related label
42549-557-02	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS USP CIII
42549-557-04	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS USP CIII
42549-557-12	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS USP CIII
42549-557-28	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS USP CIII
42549-557-30	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS USP CIII
42549-557-40	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS USP CIII
42549-557-56	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS USP CIII
42549-557-60	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS USP CIII
42549-557-84	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS USP CIII
42549-557-90	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS USP CIII

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
42549-557-02	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	112 in 1 BOTTLE	TABLET	112	5
42549-557-04	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	140 in 1 BOTTLE	TABLET	140	5
42549-557-12	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	120 in 1 BOTTLE	TABLET	120	5
42549-557-28	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	28 in 1 BOTTLE	TABLET	28	5
42549-557-30	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	30 in 1 BOTTLE	TABLET	30	5
42549-557-40	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	40 in 1 BOTTLE	TABLET	40	5
42549-557-56	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	56 in 1 BOTTLE	TABLET	56	5
42549-557-60	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	60 in 1 BOTTLE	TABLET	60	5
42549-557-84	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	84 in 1 BOTTLE	TABLET	84	5
42549-557-90	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	90 in 1 BOTTLE	TABLET	90	5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42549-557-02	EA - Each	42549-557	8a368fbd-57f0-4bae-a72e-1a5bb415d066	1	2012-07-24
42549-557-28	EA - Each	42549-557	599ec325-bb9e-4cce-8c89-0a3631b6cdbb	1	2012-07-24
42549-557-30	EA - Each	42549-557	97fc0798-56d9-476c-b57e-11088d4ba96e	1	2012-07-24
42549-557-40	EA - Each	42549-557	23c49557-e382-4d7c-bf06-a6d2afb908bc	1	2012-07-24
42549-557-56	EA - Each	42549-557	20a09088-c5eb-4021-b963-f128c29a2f03	1	2012-07-24
42549-557-60	EA - Each	42549-557	5f487fd1-598e-495a-9efc-4467656ddb0c	1	2012-07-24
42549-557-90	EA - Each	42549-557	a2f4d152-c6b6-49db-815b-9bd234a1167d	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 TABLET [STAT RX USA LLC]	5
HYDROCODONE BITARTRATE	ACTIVE INGREDIENT	NO70W886KK	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [STAT RX USA LLC]	5
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [STAT RX USA LLC]	5
HYDROCODONE	ACTIVE MOIETY	6YKS4Y3WQ7	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [STAT RX USA LLC]	5
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [STAT RX USA LLC]	5
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [STAT RX USA LLC]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [STAT RX USA LLC]	5
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [STAT RX USA LLC]	5
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [STAT RX USA LLC]	5
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [STAT RX USA LLC]	5
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [STAT RX USA LLC]	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42549-557	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [STAT RX USA LLC]	5	Legacy NDC, 10 package rows	20120202_c8be6c8d-7c55-459b-bc16-7651c2fd6e27.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 · 2 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	SpecGx LLC	73c1059b-0c7d-42ef-9827-f018858fc447	2026-04-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040405 application number: ANDA040405
HYDROCODONE/APAP	HYDROCODONE/APAP	Direct_Rx	efe3b2eb-5c26-3783-e053-2995a90a6ba8	2025-01-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040405 application number: ANDA040405

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	c8be6c8d-7c55-459b-bc16-7651c2fd6e27	5
857002	HYDROcodone bitartrate 5 MG / acetaminophen 325 MG Oral Tablet	PSN	c8be6c8d-7c55-459b-bc16-7651c2fd6e27	5
856903	HYDROcodone bitartrate 5 MG / acetaminophen 500 MG Oral Tablet	PSN	c8be6c8d-7c55-459b-bc16-7651c2fd6e27	5
857005	HYDROcodone bitartrate 7.5 MG / acetaminophen 325 MG Oral Tablet	PSN	c8be6c8d-7c55-459b-bc16-7651c2fd6e27	5
857118	HYDROcodone bitartrate 7.5 MG / acetaminophen 500 MG Oral Tablet	PSN	c8be6c8d-7c55-459b-bc16-7651c2fd6e27	5
856999	acetaminophen 325 MG / hydrocodone bitartrate 10 MG Oral Tablet	SCD	c8be6c8d-7c55-459b-bc16-7651c2fd6e27	5
857002	acetaminophen 325 MG / hydrocodone bitartrate 5 MG Oral Tablet	SCD	c8be6c8d-7c55-459b-bc16-7651c2fd6e27	5
857005	acetaminophen 325 MG / hydrocodone bitartrate 7.5 MG Oral Tablet	SCD	c8be6c8d-7c55-459b-bc16-7651c2fd6e27	5
856903	acetaminophen 500 MG / hydrocodone bitartrate 5 MG Oral Tablet	SCD	c8be6c8d-7c55-459b-bc16-7651c2fd6e27	5
857118	acetaminophen 500 MG / hydrocodone bitartrate 7.5 MG Oral Tablet	SCD	c8be6c8d-7c55-459b-bc16-7651c2fd6e27	5
856999	APAP 325 MG / hydrocodone bitartrate 10 MG Oral Tablet	SY	c8be6c8d-7c55-459b-bc16-7651c2fd6e27	5
857002	APAP 325 MG / hydrocodone bitartrate 5 MG Oral Tablet	SY	c8be6c8d-7c55-459b-bc16-7651c2fd6e27	5
857005	APAP 325 MG / hydrocodone bitartrate 7.5 MG Oral Tablet	SY	c8be6c8d-7c55-459b-bc16-7651c2fd6e27	5
856903	APAP 500 MG / hydrocodone bitartrate 5 MG Oral Tablet	SY	c8be6c8d-7c55-459b-bc16-7651c2fd6e27	5
857118	APAP 500 MG / hydrocodone bitartrate 7.5 MG Oral Tablet	SY	c8be6c8d-7c55-459b-bc16-7651c2fd6e27	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
42549-557-02	42549055702	112 in 1 BOTTLE	Historical
42549-557-04	42549055704	140 in 1 BOTTLE	Historical
42549-557-12	42549055712	120 in 1 BOTTLE	Historical
42549-557-28	42549055728	28 in 1 BOTTLE	Historical
42549-557-30	42549055730	30 in 1 BOTTLE	Historical
42549-557-40	42549055740	40 in 1 BOTTLE	Historical
42549-557-56	42549055756	56 in 1 BOTTLE	Historical
42549-557-60	42549055760	60 in 1 BOTTLE	Historical
42549-557-84	42549055784	84 in 1 BOTTLE	Historical
42549-557-90	42549055790	90 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS USP CIII	STAT Rx USA LLC \| PSS World Medical Inc.	2012-01-31	HUMAN PRESCRIPTION DRUG LABEL	5