Hydrocodone Bitartrate and Acetaminophen

Product NDC: 40032-356
11-digit product format: 400320356
Labeler code: 40032
Product ID: 40032-356_102fbf8d-aff3-4f1c-b75b-deb9e4e22329
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Hydrocodone Bitartrate and Acetaminophen
Dosage form: TABLET
Route: ORAL
Labeler: Novel Laboratories, Inc.
Application: ANDA206245
Marketing category: ANDA
Marketing start: 2016-12-01
Marketing end: 0000-00-00
Substance: HYDROCODONE BITARTRATE; ACETAMINOPHEN
Active strength: 5 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 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	40032-356		I	Inactivated by FDA	2026-08-11
excluded package	package	40032-356	40032-356-01	I	Inactivated by FDA	2026-08-11
excluded package	package	40032-356	40032-356-03	I	Inactivated by FDA	2026-08-11
excluded package	package	40032-356	40032-356-05	I	Inactivated by FDA	2026-08-11
excluded package	package	40032-356	40032-356-10	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 1 · 45 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	40032-356-01	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	40032-356-10	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	40032-356-05	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	40032-356-03	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	40032-356-01	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	40032-356-10	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	40032-356-05	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	40032-356-03	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	40032-356-01	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	40032-356-10	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	40032-356-05	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	40032-356-03	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	40032-356-01	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	40032-356-10	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	40032-356-05	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	40032-356-03	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	40032-356-01	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	40032-356-10	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	40032-356-05	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	40032-356-03	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	40032-356-01	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	40032-356-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	40032-356-05	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	40032-356-03	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	40032-356-01	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	40032-356-05	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	40032-356-10	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	40032-356-03	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	40032-356-01	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	40032-356-05	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	40032-356-10	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	40032-356-03	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	40032-356-01	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	40032-356-05	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	40032-356-10	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	40032-356-03	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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

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
A206245-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	ACETAMINOPHEN; HYDROCODONE BITARTRATE	325MG;5MG	TABLET / ORAL	2016-12-01
A206245-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	ACETAMINOPHEN; HYDROCODONE BITARTRATE	325MG;7.5MG	TABLET / ORAL	2016-12-01
A206245-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	ACETAMINOPHEN; HYDROCODONE BITARTRATE	325MG;10MG	TABLET / ORAL	2016-12-01

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 · 123 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	A206245-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	2016-12-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206245-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	2016-12-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206245-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	2016-12-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206245-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	2016-12-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206245-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	2016-12-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206245-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	2016-12-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206245-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	2016-12-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206245-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	2016-12-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206245-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	2016-12-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206245-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	2016-12-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206245-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	2016-12-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206245-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	2016-12-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206245-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	2016-12-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206245-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	2016-12-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206245-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	2016-12-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206245-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	2016-12-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206245-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	2016-12-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206245-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	2016-12-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206245-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	2016-12-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206245-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	2016-12-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206245-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	2016-12-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206245-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	2016-12-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206245-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	2016-12-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206245-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	2016-12-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206245-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	2016-12-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206245-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	2016-12-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206245-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	2016-12-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206245-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	2016-12-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206245-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	2016-12-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206245-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	2016-12-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206245-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	2016-12-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206245-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	2016-12-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206245-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	2016-12-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206245-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	2016-12-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206245-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	2016-12-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206245-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	2016-12-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206245-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	2016-12-01	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206245-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	2016-12-01	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206245-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	2016-12-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206245-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	2016-12-01	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 69 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	A206245-001	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206245-002	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206245-003	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206245-001	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A206245-002	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A206245-003	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206245-001	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A206245-002	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A206245-003	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206245-001	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A206245-002	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A206245-003	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206245-001	AA	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A206245-002	AA	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A206245-003	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206245-001	AA	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A206245-002	AA	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A206245-003	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206245-001	AA	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206245-002	AA	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206245-003	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206245-001	AA	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A206245-002	AA	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A206245-003	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206245-001	AA	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A206245-002	AA	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A206245-003	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206245-001	AA	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A206245-002	AA	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A206245-003	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206245-001	AA	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A206245-002	AA	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A206245-003	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206245-001	AA	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A206245-002	AA	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A206245-003	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206245-001	AA	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A206245-002	AA	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A206245-003	AA	1	`ea99ee380514…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206245-001	AA	1	`a72a2bbeb626…`

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
40032-356-01	Hydrocodone Bitartrate and Acetaminophen Tablets, USP CII Rx Only
40032-356-03	Hydrocodone Bitartrate and Acetaminophen Tablets, USP CII Rx Only
40032-356-05	Hydrocodone Bitartrate and Acetaminophen Tablets, USP CII Rx Only
40032-356-10	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
40032-356-01	Hydrocodone Bitartrate and Acetaminophen	100 in 1 BOTTLE	TABLET	100	10
40032-356-03	Hydrocodone Bitartrate and Acetaminophen	30 in 1 BOTTLE	TABLET	30	10
40032-356-05	Hydrocodone Bitartrate and Acetaminophen	500 in 1 BOTTLE	TABLET	500	10
40032-356-10	Hydrocodone Bitartrate and Acetaminophen	1000 in 1 BOTTLE	TABLET	1000	10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
40032-356	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [NOVEL LABORATORIES, INC.]	10	Legacy NDC, 4 package rows	20191221_7a89f126-9092-42f9-b048-94454d66302c.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydrocodone Bitartrate and Acetaminophen	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	Lupin Pharmaceuticals,Inc.	26a2178e-e0e5-4d61-81fd-e30a3142f1f2	2024-02-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206245 application number: ANDA206245

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	7a89f126-9092-42f9-b048-94454d66302c	10
857002	HYDROcodone bitartrate 5 MG / acetaminophen 325 MG Oral Tablet	PSN	7a89f126-9092-42f9-b048-94454d66302c	10
857005	HYDROcodone bitartrate 7.5 MG / acetaminophen 325 MG Oral Tablet	PSN	7a89f126-9092-42f9-b048-94454d66302c	10
856999	acetaminophen 325 MG / hydrocodone bitartrate 10 MG Oral Tablet	SCD	7a89f126-9092-42f9-b048-94454d66302c	10
857002	acetaminophen 325 MG / hydrocodone bitartrate 5 MG Oral Tablet	SCD	7a89f126-9092-42f9-b048-94454d66302c	10
857005	acetaminophen 325 MG / hydrocodone bitartrate 7.5 MG Oral Tablet	SCD	7a89f126-9092-42f9-b048-94454d66302c	10
856999	APAP 325 MG / hydrocodone bitartrate 10 MG Oral Tablet	SY	7a89f126-9092-42f9-b048-94454d66302c	10
857002	APAP 325 MG / hydrocodone bitartrate 5 MG Oral Tablet	SY	7a89f126-9092-42f9-b048-94454d66302c	10
857005	APAP 325 MG / hydrocodone bitartrate 7.5 MG Oral Tablet	SY	7a89f126-9092-42f9-b048-94454d66302c	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
40032-356-01	40032035601	100 TABLET in 1 BOTTLE (40032-356-01)	100 tablet	2016-12-01	0000-00-00	No	No	Current
40032-356-03	40032035603	30 TABLET in 1 BOTTLE (40032-356-03)	30 tablet	2016-12-01	0000-00-00	No	No	Current
40032-356-05	40032035605	500 TABLET in 1 BOTTLE (40032-356-05)	500 tablet	2016-12-01	0000-00-00	No	No	Current
40032-356-10	40032035610	1000 TABLET in 1 BOTTLE (40032-356-10)	1000 tablet	2016-12-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Hydrocodone Bitartrate and Acetaminophen Tablets, USP CII Rx Only	Novel Laboratories, Inc.	2019-09-04	HUMAN PRESCRIPTION DRUG LABEL	10