HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product NDC: 12634-260
11-digit product format: 126340260
Labeler code: 12634
Product ID: 12634-260_34f02e3f-cc77-53e4-e054-00144ff88e88
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: hydrocodone bitartrate and acetaminophen
Dosage form: TABLET
Route: ORAL
Labeler: Apotheca Inc.
Application: ANDA090118
Marketing category: ANDA
Marketing start: 2009-03-30
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: CII
NDC exclude flag: No
Listing certified through: 2020-12-31
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 · 12 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	12634-260		I	Inactivated by FDA	2026-09-09
excluded package	package	12634-260	12634-260-00	I	Inactivated by FDA	2026-09-09
excluded package	package	12634-260	12634-260-40	I	Inactivated by FDA	2026-09-09
excluded package	package	12634-260	12634-260-50	I	Inactivated by FDA	2026-09-09
excluded package	package	12634-260	12634-260-55	I	Inactivated by FDA	2026-09-09
excluded package	package	12634-260	12634-260-66	I	Inactivated by FDA	2026-09-09
excluded package	package	12634-260	12634-260-71	I	Inactivated by FDA	2026-09-09
excluded package	package	12634-260	12634-260-79	I	Inactivated by FDA	2026-09-09
excluded package	package	12634-260	12634-260-80	I	Inactivated by FDA	2026-09-09
excluded package	package	12634-260	12634-260-85	I	Inactivated by FDA	2026-09-09
excluded package	package	12634-260	12634-260-91	I	Inactivated by FDA	2026-09-09
excluded package	package	12634-260	12634-260-94	I	Inactivated by FDA	2026-09-09

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 4 · 228 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-260-50	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-260-85	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-260-91	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-260-79	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-260-66	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-260-55	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-260-00	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-260-80	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-260-40	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-260-71	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-260-94	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-260-50	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-260-85	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-260-91	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-260-79	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-260-66	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-260-55	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-260-00	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-260-80	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-260-40	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-260-71	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-260-94	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-260-50	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-260-85	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-260-91	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-260-79	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-260-66	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-260-55	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-260-00	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-260-80	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-260-40	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-260-71	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-260-94	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	12634-260-50	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	12634-260-85	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	12634-260-91	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	12634-260-79	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	12634-260-66	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	12634-260-55	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	12634-260-00	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	12634-260-80	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	12634-260-40	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	12634-260-71	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	12634-260-94	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	12634-260-50	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	12634-260-85	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	12634-260-91	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	12634-260-79	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	12634-260-66	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	12634-260-55	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	12634-260-00	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	12634-260-80	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	12634-260-40	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	12634-260-71	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	12634-260-94	`cfe11265f3b6…`	`090c488252e2…`

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A090118-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	ACETAMINOPHEN; HYDROCODONE BITARTRATE	325MG;5MG	TABLET / ORAL	2008-12-23
A090118-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	ACETAMINOPHEN; HYDROCODONE BITARTRATE	325MG;7.5MG	TABLET / ORAL	2008-12-23
A090118-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	ACETAMINOPHEN; HYDROCODONE BITARTRATE	325MG;10MG	TABLET / ORAL	2008-12-23

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 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A090118-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	2008-12-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090118-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	2008-12-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090118-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	2008-12-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090118-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	2008-12-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090118-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	2008-12-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090118-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	2008-12-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090118-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	2008-12-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090118-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	2008-12-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090118-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	2008-12-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090118-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	2008-12-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090118-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	2008-12-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090118-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	2008-12-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090118-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	2008-12-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090118-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	2008-12-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090118-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	2008-12-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090118-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	2008-12-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090118-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	2008-12-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090118-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	2008-12-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090118-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	2008-12-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090118-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	2008-12-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090118-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	2008-12-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090118-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	2008-12-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090118-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	2008-12-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090118-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	2008-12-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090118-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	2008-12-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090118-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	2008-12-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090118-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	2008-12-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090118-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	2008-12-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090118-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	2008-12-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090118-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	2008-12-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090118-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	2008-12-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090118-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	2008-12-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090118-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	2008-12-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090118-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	2008-12-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090118-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	2008-12-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090118-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	2008-12-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090118-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	2008-12-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090118-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	2008-12-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090118-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	2008-12-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090118-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	2008-12-23	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 60 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090118-001	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090118-002	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090118-003	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090118-001	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090118-002	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090118-003	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090118-001	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090118-002	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090118-003	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090118-001	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090118-002	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090118-003	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090118-001	AA	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090118-002	AA	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090118-003	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090118-001	AA	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090118-002	AA	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090118-003	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090118-001	AA	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090118-002	AA	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090118-003	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090118-001	AA	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A090118-002	AA	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A090118-003	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090118-001	AA	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A090118-002	AA	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A090118-003	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090118-001	AA	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A090118-002	AA	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A090118-003	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090118-001	AA	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A090118-002	AA	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A090118-003	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090118-001	AA	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A090118-002	AA	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A090118-003	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090118-001	AA	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A090118-002	AA	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A090118-003	AA	1	`ea99ee380514…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090118-001	AA	1	`3f0d92c62455…`

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
12634-260-00	Hydrocodone Bitartrate and Acetaminophen Tablets, USP CII Rx Only
12634-260-40	Hydrocodone Bitartrate and Acetaminophen Tablets, USP CII Rx Only
12634-260-50	Hydrocodone Bitartrate and Acetaminophen Tablets, USP CII Rx Only
12634-260-55	Hydrocodone Bitartrate and Acetaminophen Tablets, USP CII Rx Only
12634-260-66	Hydrocodone Bitartrate and Acetaminophen Tablets, USP CII Rx Only
12634-260-71	Hydrocodone Bitartrate and Acetaminophen Tablets, USP CII Rx Only
12634-260-79	Hydrocodone Bitartrate and Acetaminophen Tablets, USP CII Rx Only
12634-260-80	Hydrocodone Bitartrate and Acetaminophen Tablets, USP CII Rx Only
12634-260-85	Hydrocodone Bitartrate and Acetaminophen Tablets, USP CII Rx Only
12634-260-91	Hydrocodone Bitartrate and Acetaminophen Tablets, USP CII Rx Only
12634-260-94	Hydrocodone Bitartrate and Acetaminophen Tablets, USP CII Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
12634-260-00	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	10 in 1 BOTTLE	TABLET	10	16
12634-260-40	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	40 in 1 BOTTLE	TABLET	40	16
12634-260-50	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	50 in 1 BOTTLE	TABLET	50	16
12634-260-55	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	15 in 1 BLISTER PACK	TABLET	15	16
12634-260-66	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	6 in 1 BLISTER PACK	TABLET	6	16
12634-260-71	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	30 in 1 BOTTLE	TABLET	30	16
12634-260-79	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	25 in 1 BOTTLE	TABLET	25	16
12634-260-80	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	20 in 1 BOTTLE	TABLET	20	16
12634-260-85	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	15 in 1 BOTTLE	TABLET	15	16
12634-260-91	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	1 in 1 BLISTER PACK	TABLET	1	16
12634-260-94	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	4 in 1 BOTTLE	TABLET	4	16

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINPHEN) TABLET [APOTHECA, INC.]	1
HYDROCODONE BITARTRATE	ACTIVE INGREDIENT	NO70W886KK	HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINPHEN) TABLET [APOTHECA, INC.]	1
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINPHEN) TABLET [APOTHECA, INC.]	1
HYDROCODONE	ACTIVE MOIETY	6YKS4Y3WQ7	HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINPHEN) TABLET [APOTHECA, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINPHEN) TABLET [APOTHECA, INC.]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINPHEN) TABLET [APOTHECA, INC.]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINPHEN) TABLET [APOTHECA, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINPHEN) TABLET [APOTHECA, INC.]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINPHEN) TABLET [APOTHECA, INC.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINPHEN) TABLET [APOTHECA, INC.]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINPHEN) TABLET [APOTHECA, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
12634-260	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [APOTHECA INC.]	16	Legacy NDC, 11 package rows	20160610_fe743045-6501-4d99-ae8d-7b0f3e27c656.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
NO70W886KK	HYDROCODONE BITARTRATE	34195-34-1	HYDROCODONE BITARTRATE
362O9ITL9D	ACETAMINOPHEN	103-90-2	ACETAMINOPHEN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
857005	HYDROcodone bitartrate 7.5 MG / acetaminophen 325 MG Oral Tablet	PSN	fe743045-6501-4d99-ae8d-7b0f3e27c656	16
857005	acetaminophen 325 MG / hydrocodone bitartrate 7.5 MG Oral Tablet	SCD	fe743045-6501-4d99-ae8d-7b0f3e27c656	16
857005	APAP 325 MG / hydrocodone bitartrate 7.5 MG Oral Tablet	SY	fe743045-6501-4d99-ae8d-7b0f3e27c656	16

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
12634-260-00	12634026000	10 in 1 BOTTLE	Historical
12634-260-40	12634026040	40 in 1 BOTTLE	Historical
12634-260-50	12634026050	50 in 1 BOTTLE	Historical
12634-260-55	12634026055	15 in 1 BLISTER PACK	Historical
12634-260-66	12634026066	6 in 1 BLISTER PACK	Historical
12634-260-71	12634026071	30 in 1 BOTTLE	Historical
12634-260-79	12634026079	25 in 1 BOTTLE	Historical
12634-260-80	12634026080	20 in 1 BOTTLE	Historical
12634-260-85	12634026085	15 in 1 BOTTLE	Historical
12634-260-91	12634026091	1 in 1 BLISTER PACK	Historical
12634-260-94	12634026094	4 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Hydrocodone Bitartrate and Acetaminophen Tablets, USP CII Rx Only	Apotheca Inc.	2016-06-10	HUMAN PRESCRIPTION DRUG LABEL	16