Norco

Product NDC: 72189-399
11-digit product format: 721890399
Labeler code: 72189
Product ID: 72189-399_2c4ce870-c59f-df00-e063-6394a90a9011
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Hydrocodone/APAP
Dosage form: TABLET
Route: ORAL
Labeler: Direct_Rx
Application: ANDA040400
Marketing category: ANDA
Marketing start: 2022-11-23
Substance: ACETAMINOPHEN; HYDROCODONE BITARTRATE
Active strength: 325; 10 mg/1; mg/1
Pharmacologic classes: Opioid Agonist [EPC], Opioid Agonists [MoA]
DEA schedule: CII
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 10 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
2025-01-20 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	72189-399-72	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	72189-399-90	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	72189-399-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	72189-399-60	`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	72189-399-72	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	72189-399-90	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	72189-399-30	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	72189-399-60	`0efc9e666f02…`	`f202fb6c5f17…`

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

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040400-001	AA

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 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	A040400-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	RS	2000-07-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040400-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	RS	2000-07-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040400-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	RS	2000-07-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040400-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	RS	2000-07-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040400-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	RS	2000-07-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040400-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	RS	2000-07-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040400-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	RS	2000-07-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040400-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	RS	2000-07-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040400-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	RS	2000-07-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040400-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	RS	2000-07-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040400-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	RS	2000-07-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040400-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	RS	2000-07-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040400-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	RS	2000-07-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040400-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	RS	2000-07-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040400-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	RS	2000-07-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040400-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	RS	2000-07-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040400-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	RS	2000-07-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040400-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA		2000-07-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040400-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	RS	2000-07-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040400-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	RS	2000-07-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040400-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA		2000-07-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040400-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA		2000-07-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040400-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA		2000-07-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040400-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA		2000-07-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040400-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA		2000-07-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040400-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA		2000-07-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040400-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA		2000-07-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040400-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	RS	2000-07-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040400-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	RS	2000-07-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040400-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	RS	2000-07-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040400-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	RS	2000-07-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040400-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	RS	2000-07-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040400-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	RS	2000-07-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040400-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	RS	2000-07-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040400-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	RS	2000-07-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040400-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	RS	2000-07-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040400-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	RS	2000-07-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040400-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	RS	2000-07-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040400-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	RS	2000-07-26	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040400-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	RS	2000-07-26	`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	A040400-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040400-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040400-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040400-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040400-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040400-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040400-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040400-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040400-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040400-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040400-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040400-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040400-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040400-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040400-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040400-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040400-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040400-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040400-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040400-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040400-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040400-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040400-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040400-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040400-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040400-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040400-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040400-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040400-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040400-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040400-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040400-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040400-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040400-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040400-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040400-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040400-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040400-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040400-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040400-001	AA	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Norco
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
HYDROCODONE BITARTRATE	325 mg/1
ACETAMINOPHEN	10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
NO70W886KK	Internal UNII lookup
362O9ITL9D	Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
ee248dfd-7aa7-7dcc-e053-2995a90af19f	Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
72189-399-30	Norco	30 in 1 BOTTLE	TABLET	30	3
72189-399-60	Norco	60 in 1 BOTTLE	TABLET	60	3
72189-399-72	Norco	120 in 1 BOTTLE	TABLET	120	3
72189-399-90	Norco	90 in 1 BOTTLE	TABLET	90	3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72189-399-30	EA - Each	72189-399	efe03979-f67d-4141-9127-d24fbb2666f2	1	2023-01-09
72189-399-60	EA - Each	72189-399	26bd3f4c-9d5a-460e-986f-91b5c9d8ab83	1	2023-01-09
72189-399-72	EA - Each	72189-399	100e072c-758d-4f47-9037-0ed4b48c4ac2	1	2023-04-07
72189-399-90	EA - Each	72189-399	aeb1ace8-4c65-4ca0-9832-ec20f5897d47	1	2023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72189-399	NORCO (HYDROCODONE/APAP) TABLET [DIRECT_RX]	3	Current NDC, Legacy NDC, 4 package rows	20250123_ee248dfd-7aa7-7dcc-e053-2995a90af19f.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
HYDROCODONE BITARTRATE AND ACETAMINOPHEN	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	ST. MARY'S MEDICAL PARK PHARMACY	3d342071-7fdd-d899-e063-6294a90ae782	2026-05-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040400 application number: ANDA040400
HYDROCODONE BITARTRATE AND ACETAMINOPHEN	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	SpecGx LLC	73c1059b-0c7d-42ef-9827-f018858fc447	2026-04-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040400 application number: ANDA040400
Norco	HYDROCODONE/APAP	Direct_Rx	ee248dfd-7aa7-7dcc-e053-2995a90af19f	2025-01-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040400 application number: ANDA040400 ndc (product): 72189-399
HYDROCODONE BITARTRATE AND ACETAMINOPHEN	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	Quality Care Products, LLC	e7d36246-9c80-49b6-ad4b-e38c3fd6d068	2024-12-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040400 application number: ANDA040400
HYDROCODONE BITARTRATE AND ACETAMINOPHEN	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	Golden State Medical Supply, Inc.	87ed3420-1697-6f42-e053-2995a90a1a5b	2024-12-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040400 application number: ANDA040400
HYDROCODONE BITARTRATE AND ACETAMINOPHEN	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	Proficient Rx LP	62dd3c7a-4150-44a2-b05b-bc31308f2200	2023-08-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040400 application number: ANDA040400

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
72189-399-30	72189039930	30 TABLET in 1 BOTTLE (72189-399-30)	30 tablet	2022-11-23	0000-00-00	No	No	Current
72189-399-60	72189039960	60 TABLET in 1 BOTTLE (72189-399-60)	60 tablet	2022-11-23	0000-00-00	No	No	Current
72189-399-72	72189039972	120 TABLET in 1 BOTTLE (72189-399-72)	120 tablet	2022-11-23		No	No	Current
72189-399-90	72189039990	90 TABLET in 1 BOTTLE (72189-399-90)	90 tablet	2022-11-23		No	No	Current