HYDROCODONE BITARTRATE

Product NDC: 61919-494
Requested package NDC: 61919-494-08
11-digit product format: 619190494
Labeler code: 61919
Product ID: 61919-494_f2147260-be71-3f01-e053-2995a90ac7b6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: HYDROCODONE BITARTRATE
Dosage form: TABLET
Route: ORAL
Labeler: DIRECT RX
Application: ANDA040736
Marketing category: ANDA
Marketing start: 2014-01-01
Marketing end: 0000-00-00
Substance: ACETAMINOPHEN; HYDROCODONE BITARTRATE
Active strength: 325 mg/1; mg/1
Pharmacologic classes: Opioid Agonist [EPC], Opioid Agonists [MoA]
DEA schedule: CII
NDC exclude flag: No
Listing certified through: 2024-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	61919-494	61919-494-08	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 1 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

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

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
A040736-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	ACETAMINOPHEN; HYDROCODONE BITARTRATE	325MG;5MG	TABLET / ORAL	AA		2006-08-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040736-001	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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A040736-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2006-08-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040736-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2006-08-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040736-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2006-08-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040736-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2006-08-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040736-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2006-08-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040736-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2006-08-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040736-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2006-08-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040736-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2006-08-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040736-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2006-08-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040736-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2006-08-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040736-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2006-08-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040736-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2006-08-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040736-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2006-08-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040736-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2006-08-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040736-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2006-08-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040736-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2006-08-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040736-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2006-08-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040736-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2006-08-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040736-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2006-08-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040736-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2006-08-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040736-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2006-08-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040736-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2006-08-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040736-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2006-08-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040736-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2006-08-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040736-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2006-08-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040736-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2006-08-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040736-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2006-08-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040736-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2006-08-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040736-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2006-08-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040736-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2006-08-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040736-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2006-08-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040736-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2006-08-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040736-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2006-08-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040736-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2006-08-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040736-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2006-08-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040736-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2006-08-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040736-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2006-08-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040736-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2006-08-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040736-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2006-08-25	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040736-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2006-08-25	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A040736-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040736-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040736-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040736-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040736-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040736-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040736-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040736-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040736-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040736-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040736-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040736-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040736-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040736-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040736-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040736-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040736-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040736-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040736-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040736-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040736-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040736-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040736-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040736-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040736-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040736-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040736-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040736-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040736-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040736-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040736-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040736-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040736-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040736-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040736-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040736-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040736-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040736-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040736-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040736-001	AA	1	`e64feba35796…`

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, Indexing SPL table
NDC	Effective	Indexing SPL	Related label
61919-494-30	2025-01-30	9d75b9d0-d690-f424-e053-dadaa90a57ce	HYDROCODONE BITARTRATE
61919-494-60	2025-01-30	9d75b9d0-d690-f424-e053-dadaa90a57ce	HYDROCODONE BITARTRATE
61919-494-72	2025-01-30	9d75b9d0-d690-f424-e053-dadaa90a57ce	HYDROCODONE BITARTRATE
61919-494-90	2025-01-30	9d75b9d0-d690-f424-e053-dadaa90a57ce	HYDROCODONE BITARTRATE
61919-494-08	2023-01-30	f386c64a-2260-0266-e053-dadaa90a7c1a	HYDROCODONE BITARTRATE
61919-494-20	2023-01-30	f386c64a-2260-0266-e053-dadaa90a7c1a	HYDROCODONE BITARTRATE
61919-494-72	2022-09-30	9d75b9d0-d690-f424-e053-dadaa90a57ce	HYDROCODONE BITARTRATE
61919-494-72	2020-01-31	9d75b9d0-d690-f424-e053-dadaa90a57ce	HYDROCODONE BITARTRATE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
61919-494-30	HYDROCODONE BITARTRATE	30 in 1 BOTTLE	TABLET	30	10
61919-494-60	HYDROCODONE BITARTRATE	60 in 1 BOTTLE	TABLET	60	10
61919-494-72	HYDROCODONE BITARTRATE	120 in 1 BOTTLE	TABLET	120	10
61919-494-90	HYDROCODONE BITARTRATE	90 in 1 BOTTLE	TABLET	90	10
61919-494-08	HYDROCODONE BITARTRATE	8 in 1 BOTTLE	TABLET	8	4
61919-494-20	HYDROCODONE BITARTRATE	20 in 1 BOTTLE	TABLET	20	4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61919-494-08	EA - Each	61919-494	a2f7a0ed-3147-432b-9d60-ad137a72181d	1	2021-07-15
61919-494-20	EA - Each	61919-494	b9c1d797-cd12-4c1e-b865-40aa61b0a5f5	1	2019-08-06
61919-494-30	EA - Each	61919-494	9782b6df-dc1d-4352-b23c-55b912766142	1	2014-06-03
61919-494-60	EA - Each	61919-494	3f940aa4-e9d9-493b-a968-9456deda3e49	1	2014-06-03
61919-494-72	EA - Each	61919-494	f96002eb-f831-4966-b93f-a4f51ed2e1ff	1	2015-10-02
61919-494-90	EA - Each	61919-494	8c383bd8-3a00-4acb-b6c1-df577c7b9318	1	2014-06-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	HYDROCODONE BITARTRATE TABLET [DIRECT RX]	2
HYDROCODONE BITARTRATE	ACTIVE INGREDIENT	NO70W886KK	HYDROCODONE BITARTRATE TABLET [DIRECT RX]	2
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	HYDROCODONE BITARTRATE TABLET [DIRECT RX]	2
HYDROCODONE	ACTIVE MOIETY	6YKS4Y3WQ7	HYDROCODONE BITARTRATE TABLET [DIRECT RX]	2
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	HYDROCODONE BITARTRATE TABLET [DIRECT RX]	2
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	HYDROCODONE BITARTRATE TABLET [DIRECT RX]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	HYDROCODONE BITARTRATE TABLET [DIRECT RX]	2
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	HYDROCODONE BITARTRATE TABLET [DIRECT RX]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61919-494	HYDROCODONE BITARTRATE TABLET [DIRECT RX]	10	Legacy NDC, 4 package rows	20230428_fa2a09a8-7835-4261-a9b1-b35adab27de7.zip
61919-494	HYDROCODONE BITARTRATE TABLET [DIRECT_RX]	4	Legacy NDC, 2 package rows	20210608_8e5b9848-283b-5fbf-e053-2a95a90ad5a1.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 · 4 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	Amneal Pharmaceuticals of New York LLC	62be4147-6a72-49e5-9338-10887c65a93a	2025-10-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040736 application number: ANDA040736
Hydrocodone Bitartrate and Acetaminophen	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	AvPAK	5174bd9a-b777-a6e3-f72f-c16082ee67d3	2025-10-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040736 application number: ANDA040736
Hydrocodone Bitartrate and Acetaminophen	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	Bryant Ranch Prepack	a200d099-fa55-4ef1-b8d7-936a7da1db00	2025-09-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040736 application number: ANDA040736
Hydrocodone Bitartrate and Acetaminophen	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	Proficient Rx LP	50be5d00-758e-4d01-8e78-40a60dbe67e5	2021-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040736 application number: ANDA040736

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
857002	HYDROcodone bitartrate 5 MG / acetaminophen 325 MG Oral Tablet	PSN	fa2a09a8-7835-4261-a9b1-b35adab27de7	10
857002	acetaminophen 325 MG / hydrocodone bitartrate 5 MG Oral Tablet	SCD	fa2a09a8-7835-4261-a9b1-b35adab27de7	10
857002	APAP 325 MG / hydrocodone bitartrate 5 MG Oral Tablet	SY	fa2a09a8-7835-4261-a9b1-b35adab27de7	10
857002	HYDROcodone bitartrate 5 MG / acetaminophen 325 MG Oral Tablet	PSN	8e5b9848-283b-5fbf-e053-2a95a90ad5a1	4
857002	acetaminophen 325 MG / hydrocodone bitartrate 5 MG Oral Tablet	SCD	8e5b9848-283b-5fbf-e053-2a95a90ad5a1	4
857002	APAP 325 MG / hydrocodone bitartrate 5 MG Oral Tablet	SY	8e5b9848-283b-5fbf-e053-2a95a90ad5a1	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
61919-494-08	61919049408	8 TABLET in 1 BOTTLE (61919-494-08)	8 tablet	2019-07-23	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
HYDROCODONE BITARTRATE	DIRECT RX	2023-04-27	HUMAN PRESCRIPTION DRUG LABEL	10
HYDROCODONE BITARTRATE	Direct_Rx	2021-06-07	HUMAN PRESCRIPTION DRUG LABEL	4