Hydrocodone Bitartrate and Acetaminophen

Product NDC: 50436-2612
11-digit product format: 504362612
Labeler code: 50436
Product ID: 50436-2612_c224e7fb-44e1-4631-9f12-545c27368eab
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Hydrocodone Bitartrate and Acetaminophen
Dosage form: TABLET
Route: ORAL
Labeler: Unit Dose Services
Application: ANDA040148
Marketing category: ANDA
Marketing start: 2013-03-07
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: 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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	50436-2612		I	Inactivated by FDA	2026-08-11
excluded package	package	50436-2612	50436-2612-1	I	Inactivated by FDA	2026-08-11
excluded package	package	50436-2612	50436-2612-2	I	Inactivated by FDA	2026-08-11
excluded package	package	50436-2612	50436-2612-4	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 2 · 76 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	50436-2612-4	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50436-2612-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50436-2612-2	`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	50436-2612-4	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50436-2612-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50436-2612-2	`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	50436-2612-4	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50436-2612-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50436-2612-2	`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	50436-2612-4	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50436-2612-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50436-2612-2	`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	50436-2612-4	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50436-2612-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50436-2612-2	`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	50436-2612-4	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50436-2612-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50436-2612-2	`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	50436-2612-4	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50436-2612-1	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50436-2612-2	`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	50436-2612-4	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50436-2612-1	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50436-2612-2	`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	50436-2612-4	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50436-2612-1	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50436-2612-2	`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	50436-2612-4	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	50436-2612-1	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	50436-2612-2	`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	50436-2612-4	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	50436-2612-1	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	50436-2612-2	`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	50436-2612-4	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	50436-2612-1	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	50436-2612-2	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	50436-2612-4	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	50436-2612-1	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	50436-2612-2	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	50436-2612-4	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	50436-2612-1	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	50436-2612-2	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	50436-2612-4	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	50436-2612-1	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	50436-2612-2	`1332a3947898…`	`d4bfe170f9cd…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A040148-001	NORCO	ACETAMINOPHEN; HYDROCODONE BITARTRATE	325MG;10MG	TABLET / ORAL	1997-02-14
A040148-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	ACETAMINOPHEN; HYDROCODONE BITARTRATE	500MG;10MG	TABLET / ORAL	1997-02-14
A040148-003	NORCO	ACETAMINOPHEN; HYDROCODONE BITARTRATE	325MG;7.5MG	TABLET / ORAL	2000-09-12
A040148-004	NORCO	ACETAMINOPHEN; HYDROCODONE BITARTRATE	325MG;2.5MG	TABLET / ORAL	2014-07-07
A040148-005	NORCO	ACETAMINOPHEN; HYDROCODONE BITARTRATE	325MG;5MG	TABLET / ORAL	2014-07-07

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 6 · 205 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A040148-001	NORCO	325MG;10MG	TABLET / ORAL	1997-02-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040148-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	500MG;10MG	TABLET / ORAL	1997-02-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040148-003	NORCO	325MG;7.5MG	TABLET / ORAL	2000-09-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040148-004	NORCO	325MG;2.5MG	TABLET / ORAL	2014-07-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040148-005	NORCO	325MG;5MG	TABLET / ORAL	2014-07-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040148-001	NORCO	325MG;10MG	TABLET / ORAL	1997-02-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040148-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	500MG;10MG	TABLET / ORAL	1997-02-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040148-003	NORCO	325MG;7.5MG	TABLET / ORAL	2000-09-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040148-004	NORCO	325MG;2.5MG	TABLET / ORAL	2014-07-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040148-005	NORCO	325MG;5MG	TABLET / ORAL	2014-07-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040148-001	NORCO	325MG;10MG	TABLET / ORAL	1997-02-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040148-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	500MG;10MG	TABLET / ORAL	1997-02-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040148-003	NORCO	325MG;7.5MG	TABLET / ORAL	2000-09-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040148-004	NORCO	325MG;2.5MG	TABLET / ORAL	2014-07-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040148-005	NORCO	325MG;5MG	TABLET / ORAL	2014-07-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040148-001	NORCO	325MG;10MG	TABLET / ORAL	1997-02-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040148-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	500MG;10MG	TABLET / ORAL	1997-02-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040148-003	NORCO	325MG;7.5MG	TABLET / ORAL	2000-09-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040148-004	NORCO	325MG;2.5MG	TABLET / ORAL	2014-07-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040148-005	NORCO	325MG;5MG	TABLET / ORAL	2014-07-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040148-001	NORCO	325MG;10MG	TABLET / ORAL	1997-02-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040148-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	500MG;10MG	TABLET / ORAL	1997-02-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040148-003	NORCO	325MG;7.5MG	TABLET / ORAL	2000-09-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040148-004	NORCO	325MG;2.5MG	TABLET / ORAL	2014-07-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040148-005	NORCO	325MG;5MG	TABLET / ORAL	2014-07-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040148-001	NORCO	325MG;10MG	TABLET / ORAL	1997-02-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040148-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	500MG;10MG	TABLET / ORAL	1997-02-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040148-003	NORCO	325MG;7.5MG	TABLET / ORAL	2000-09-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040148-004	NORCO	325MG;2.5MG	TABLET / ORAL	2014-07-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040148-005	NORCO	325MG;5MG	TABLET / ORAL	2014-07-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040148-001	NORCO	325MG;10MG	TABLET / ORAL	1997-02-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040148-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	500MG;10MG	TABLET / ORAL	1997-02-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040148-003	NORCO	325MG;7.5MG	TABLET / ORAL	2000-09-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040148-004	NORCO	325MG;2.5MG	TABLET / ORAL	2014-07-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040148-005	NORCO	325MG;5MG	TABLET / ORAL	2014-07-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040148-001	NORCO	325MG;10MG	TABLET / ORAL	1997-02-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040148-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	500MG;10MG	TABLET / ORAL	1997-02-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040148-003	NORCO	325MG;7.5MG	TABLET / ORAL	2000-09-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040148-004	NORCO	325MG;2.5MG	TABLET / ORAL	2014-07-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040148-005	NORCO	325MG;5MG	TABLET / ORAL	2014-07-07	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A040148-001	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040148-003	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040148-004	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040148-005	AA	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040148-001	AA	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040148-003	AA	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040148-004	AA	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040148-005	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040148-001	AA	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A040148-003	AA	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A040148-004	AA	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A040148-005	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040148-001	AA	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A040148-003	AA	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A040148-004	AA	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A040148-005	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040148-001	AA	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A040148-003	AA	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A040148-004	AA	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A040148-005	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040148-001	AA	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A040148-003	AA	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A040148-004	AA	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A040148-005	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040148-001	AA	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A040148-003	AA	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A040148-004	AA	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A040148-005	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040148-001	AA	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A040148-003	AA	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A040148-004	AA	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A040148-005	AA	1	`ea99ee380514…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
06cc817f-60e0-4473-8e6b-c44d11dc5af6	Product name	9	20220921
53523715-c529-4d52-b9ff-1e5d76636f53	Product name	2	20210818
31b11e56-5b35-4ab6-a3a8-f0b48973dced	Product name	2	20200611
3a16d77a-e865-468a-aedf-6e58913c1c21	Product name	3	20190619
00d531e4-b130-8c52-eaf9-826cbb6f15dd	Product name	3	20190205
aa0f353d-f35e-62e4-4e1f-5b563f01c659	Product name	9	20190205
22d922aa-c443-d9f3-b23c-03b03a9ad31c	Product name	7	20181220
7855f8e3-562e-4273-8b79-0059c07a71f7	Product name	1	20170901
d17a97fa-387f-690e-d2be-0083ab044a03	Product name	3	20170725
0fdb98e2-b951-a1ce-5715-2b187ba500ef	Product name	4	20170718
a5244f9c-cd67-0e27-d63b-65fd7e584400	Product name	2	20170504
b654f2d9-ebeb-451d-96ee-22f583344623	Product name	1	20170424
557673c2-8256-b351-e863-4ec71a5a64b0	Product name	2	20160714
e974e22d-8688-7d92-1e87-40c1079e170c	Product name	3	20151125
4fe95224-f543-4dbb-9445-8cca122b48c8	Product name	1	20150609
e8718272-64cb-4436-969b-176c3067c8f4	Product name	1	20150609
106ff02a-57e1-4c4c-a307-fd582ff4e311	Product name	1	20150212
105ef617-6fa4-6713-326f-72ec8a6b75a9	Product name	1	20140508
53855190-7124-8179-f018-e792f7c27f28	Product name	1	20140508
61c18d4e-b552-5478-8fc0-df38b93e3100	Product name	1	20140508
84fb0b3d-1d72-b672-bc70-2b676a23e7e0	Product name	1	20140508
b8e0daf1-fb81-290b-c0bf-873be19ef775	Product name	1	20140508
d83c592c-dd97-4cbf-36ac-13da806684bd	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50436-2612-1	2021-01-29	C162847	48780-1	ba0f9c33-0de7-a910-e053-dadaa90a0b85	Hydrocodone Bitartrate and Acetaminophen Tablets USP Hydrocodone Bitartrate and Acetaminophen Tablets, USP CII Revised: May 2017
50436-2612-2	2021-01-29	C162847	48780-1	ba0f9c33-0de7-a910-e053-dadaa90a0b85	Hydrocodone Bitartrate and Acetaminophen Tablets USP Hydrocodone Bitartrate and Acetaminophen Tablets, USP CII Revised: May 2017
50436-2612-4	2021-01-29	C162847	48780-1	ba0f9c33-0de7-a910-e053-dadaa90a0b85	Hydrocodone Bitartrate and Acetaminophen Tablets USP Hydrocodone Bitartrate and Acetaminophen Tablets, USP CII Revised: May 2017

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
50436-2612-1	Hydrocodone Bitartrate and Acetaminophen	30 in 1 BOTTLE	TABLET	30	11
50436-2612-2	Hydrocodone Bitartrate and Acetaminophen	60 in 1 BOTTLE	TABLET	60	11
50436-2612-4	Hydrocodone Bitartrate and Acetaminophen	40 in 1 BOTTLE	TABLET	40	11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50436-2612-1	EA - Each	50436-2612	e7965bec-4969-4709-accb-69a278870703	1	2017-07-07
50436-2612-2	EA - Each	50436-2612	ace0472f-e961-4da8-a382-fa6859e9ac44	1	2017-07-07
50436-2612-4	EA - Each	50436-2612	9f1da155-e949-4061-b1aa-ffa050120e35	1	2017-07-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50436-2612	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [UNIT DOSE SERVICES]	11	Legacy NDC, 3 package rows	20171108_e2281546-9581-4277-9539-93c26fce2638.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
856999	HYDROcodone bitartrate 10 MG / acetaminophen 325 MG Oral Tablet	PSN	e2281546-9581-4277-9539-93c26fce2638	11
857391	HYDROcodone bitartrate 2.5 MG / acetaminophen 325 MG Oral Tablet	PSN	e2281546-9581-4277-9539-93c26fce2638	11
857005	HYDROcodone bitartrate 7.5 MG / acetaminophen 325 MG Oral Tablet	PSN	e2281546-9581-4277-9539-93c26fce2638	11
856999	acetaminophen 325 MG / hydrocodone bitartrate 10 MG Oral Tablet	SCD	e2281546-9581-4277-9539-93c26fce2638	11
857391	acetaminophen 325 MG / hydrocodone bitartrate 2.5 MG Oral Tablet	SCD	e2281546-9581-4277-9539-93c26fce2638	11
857005	acetaminophen 325 MG / hydrocodone bitartrate 7.5 MG Oral Tablet	SCD	e2281546-9581-4277-9539-93c26fce2638	11
856999	APAP 325 MG / hydrocodone bitartrate 10 MG Oral Tablet	SY	e2281546-9581-4277-9539-93c26fce2638	11
857391	APAP 325 MG / Hydrocodone Bitartrate 2.5 MG Oral Tablet	SY	e2281546-9581-4277-9539-93c26fce2638	11
857005	APAP 325 MG / hydrocodone bitartrate 7.5 MG Oral Tablet	SY	e2281546-9581-4277-9539-93c26fce2638	11

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
50436-2612-1	50436261201	30 in 1 BOTTLE	Historical
50436-2612-2	50436261202	60 in 1 BOTTLE	Historical
50436-2612-4	50436261204	40 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Hydrocodone Bitartrate and Acetaminophen	Unit Dose Services	2017-11-07	HUMAN PRESCRIPTION DRUG LABEL	11