Hydrocodone Bitartrate and Acetaminophen

Product NDC: 71930-021
11-digit product format: 719300021
Labeler code: 71930
Product ID: 71930-021_a9e9366b-97c9-4d86-962f-b3f8e3338fa9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Hydrocodone Bitartrate and Acetaminophen
Dosage form: TABLET
Route: ORAL
Labeler: Eywa Pharma Inc
Application: ANDA210211
Marketing category: ANDA
Marketing start: 2018-07-13
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

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	TE codes	Approval date
A210211-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	ACETAMINOPHEN; HYDROCODONE BITARTRATE	325MG;5MG	TABLET / ORAL	AA	2017-10-30
A210211-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	ACETAMINOPHEN; HYDROCODONE BITARTRATE	325MG;7.5MG	TABLET / ORAL	AA	2017-10-30
A210211-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	ACETAMINOPHEN; HYDROCODONE BITARTRATE	325MG;10MG	TABLET / ORAL	AA	2017-10-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A210211-001	AA
A210211-002	AA
A210211-003	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 4 · 123 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
2026-02-19 14:30 UTC	2026-02	A210211-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2017-10-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210211-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2017-10-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210211-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2017-10-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210211-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2017-10-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210211-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2017-10-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210211-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2017-10-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210211-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2017-10-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210211-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2017-10-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210211-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2017-10-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210211-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2017-10-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210211-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2017-10-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210211-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2017-10-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210211-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2017-10-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210211-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2017-10-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210211-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2017-10-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210211-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2017-10-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210211-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2017-10-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210211-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2017-10-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210211-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2017-10-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210211-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2017-10-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210211-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2017-10-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210211-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2017-10-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210211-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2017-10-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210211-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2017-10-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210211-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2017-10-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210211-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2017-10-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210211-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2017-10-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210211-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2017-10-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210211-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2017-10-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210211-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2017-10-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210211-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2017-10-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210211-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2017-10-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210211-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2017-10-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210211-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2017-10-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210211-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2017-10-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210211-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2017-10-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210211-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2017-10-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210211-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2017-10-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210211-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2017-10-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210211-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2017-10-30	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 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	A210211-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210211-002	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210211-003	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210211-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210211-002	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210211-003	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210211-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210211-002	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210211-003	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210211-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210211-002	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210211-003	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210211-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210211-002	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210211-003	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210211-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210211-002	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210211-003	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210211-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210211-002	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210211-003	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210211-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210211-002	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210211-003	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210211-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210211-002	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210211-003	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210211-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210211-002	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210211-003	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210211-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210211-002	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210211-003	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210211-001	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210211-002	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210211-003	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210211-001	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210211-002	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210211-003	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210211-001	AA	1	`8072bd15b7f6…`

Additional Listing Data#

Finished product: Yes
Brand name base: Hydrocodone Bitartrate and Acetaminophen
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 RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
856999	Internal RxNorm lookup
857002	Internal RxNorm lookup
857005	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
fcd2b59e-8087-475e-9e6b-911bd846ea96	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
75d4bef7-334c-4a95-abb5-bff9def24114	Product name	2	20260112
7dea7767-9f52-b60a-5435-33cb9cc28bae	Product name	4	20250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4	Product name	7	20250116
11939cf5-0ea7-5df5-5127-00a7ce07fd7f	Product name	5	20250115
0ca83774-3f79-b837-5d6f-c210102f3bc8	Product name	6	20250114
88300afc-e1c4-ad17-c80b-4957f1b809a5	Product name	5	20250113
4eddd6ca-259a-4c6c-a3a4-2025015ce043	Product name	7	20240611
16cde546-8deb-4df2-a072-dab5566ede95	Product name	1	20231003
20ab58de-c64a-4ec2-9210-3aa3fae2b66f	Product name	1	20230808
a3631b20-02d1-41d7-8187-5e5e850b9e80	Product name	1	20230306
79e1734e-f721-4d46-978a-be382f771672	Product name	2	20230110
41b814f3-0166-1c53-c9ef-a0794c7daf9d	Product name	3	20221110
a590be26-846c-8659-a5a1-fb25907965dc	Product name	2	20221110
06cc817f-60e0-4473-8e6b-c44d11dc5af6	Product name	9	20220921
92ead9ae-674d-4eee-a492-c385d496891f	Product name	3	20220308
53523715-c529-4d52-b9ff-1e5d76636f53	Product name	2	20210818
31b11e56-5b35-4ab6-a3a8-f0b48973dced	Product name	2	20200611
103b151b-b17f-42ac-8624-3ef62f5e2975	Product name	2	20200507
b8497372-efe9-9dde-fa2d-59be9761aa64	Product name	9	20200428
20c8cafe-5cfc-44f8-a9be-a664f437f780	Product name	2	20200225
3a16d77a-e865-468a-aedf-6e58913c1c21	Product name	3	20190619
2a0c98e1-033f-4e0d-a0da-b5291ffbe880	Product name	1	20190320
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
377068df-225f-7318-a910-a1987cdfa361	Product name	3	20170608
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
23475c0b-a5b5-4fec-b97f-acca901eae6a	Product name	1	20140718
105ef617-6fa4-6713-326f-72ec8a6b75a9	Product name	1	20140508
332e86c3-7875-ca6e-f934-2206d2b31996	Product name	1	20140508
3ed6b849-48b8-8899-c288-6eeb396123b6	Product name	1	20140508
47fd879b-91c5-e1e5-130f-29d082a871ec	Product name	1	20140508
53855190-7124-8179-f018-e792f7c27f28	Product name	1	20140508
61c18d4e-b552-5478-8fc0-df38b93e3100	Product name	1	20140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092	Product name	1	20140508
84fb0b3d-1d72-b672-bc70-2b676a23e7e0	Product name	1	20140508
96c5169b-5b9d-547d-bf22-d688d91866e4	Product name	1	20140508
b8e0daf1-fb81-290b-c0bf-873be19ef775	Product name	1	20140508
c35d1ac8-8885-2ee1-6c52-5a715b242c00	Product name	1	20140508
c8753a88-edde-8e17-a396-705537b52cee	Product name	1	20140508
cd4f9ae2-1343-ecd2-ce0f-97db0c2b51ce	Product name	1	20140508
cf3a804d-0326-aa22-0142-c184b5657d85	Product name	1	20140508
d83c592c-dd97-4cbf-36ac-13da806684bd	Product name	1	20140508
e01133ad-4dcd-c7f3-454b-2ff569ee160a	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
71930-021-12	Hydrocodone Bitartrate and Acetaminophen	100 in 1 BOTTLE	TABLET	100	8
71930-021-13	Hydrocodone Bitartrate and Acetaminophen	1000 in 1 BOTTLE	TABLET	1000	8
71930-021-52	Hydrocodone Bitartrate and Acetaminophen	500 in 1 BOTTLE	TABLET	500	8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71930-021-12	EA - Each	71930-021	00111bd1-72e7-4954-b6ae-f9dd5f55ec1d	1	2018-10-11
71930-021-13	EA - Each	71930-021	2737b85e-7618-41ce-8fd6-f8ad45f31d0e	1	2022-12-07
71930-021-52	EA - Each	71930-021	b4bb2fb2-f1e1-49d8-9688-ca5df22b14e6	1	2018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71930-021	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [EYWA PHARMA INC]	7	Current NDC, Legacy NDC, 3 package rows	20240829_fcd2b59e-8087-475e-9e6b-911bd846ea96.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 · 20 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	Bryant Ranch Prepack	65c5abc7-520a-4267-acb6-ea6204a3ecfa	2026-05-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210211 application number: ANDA210211
Hydrocodone Bitartrate and Acetaminophen	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	Bryant Ranch Prepack	080d8fbd-a2c5-45b1-a9cf-2b6dd42ec4c7	2026-05-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210211 application number: ANDA210211
Hydrocodone Bitartrate and Acetaminophen	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	Bryant Ranch Prepack	69ce724d-6440-4def-aea9-26ad284ac35c	2026-04-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210211 application number: ANDA210211
Hydrocodone Bitartrate and Acetaminophen	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	Bryant Ranch Prepack	f1a7d87c-866d-4c6d-b9fd-e809b0a21773	2026-03-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210211 application number: ANDA210211
Hydrocodone Bitartrate and Acetaminophen	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	Bryant Ranch Prepack	1d63d261-bdd4-4951-b8aa-09561e5b19fc	2026-03-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210211 application number: ANDA210211
Hydrocodone Bitartrate and Acetaminophen	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	Bryant Ranch Prepack	09db348f-8396-41b2-b639-608dcfdbccf4	2026-03-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210211 application number: ANDA210211
Hydrocodone Bitartrate and Acetaminophen	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	Bryant Ranch Prepack	db14e63a-8e3e-4524-b45a-cb09f705f73a	2026-03-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210211 application number: ANDA210211
Hydrocodone Bitartrate and Acetaminophen	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	Bryant Ranch Prepack	e5b559c3-4beb-4ba3-a10b-7a1ad1878a1e	2026-03-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210211 application number: ANDA210211
Hydrocodone Bitartrate and Acetaminophen	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	Bryant Ranch Prepack	c534f784-0e21-4891-8f7e-2dc327b267f1	2026-03-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210211 application number: ANDA210211
Hydrocodone Bitartrate and Acetaminophen	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	Asclemed USA, Inc.	66e184cd-fa32-431f-b843-9c4bea12593b	2026-03-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210211 application number: ANDA210211
Hydrocodone Bitartrate and Acetaminophen	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	Redpharm Drug	46c13d54-b181-4da2-e063-6294a90ab5c5	2026-03-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210211 application number: ANDA210211
Hydrocodone/APAP	HYDROCODONE/APAP	Direct_Rx	446e9f78-4034-5bb4-e063-6394a90ac739	2026-02-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210211 application number: ANDA210211
Hydrocodone/APAP	HYDROCODONE/APAP	Direct_Rx	446f01f0-2853-d104-e063-6394a90ae351	2026-02-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210211 application number: ANDA210211
Hydrocodone Bitartrate and Acetaminophen	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	Eywa Pharma Inc	fcd2b59e-8087-475e-9e6b-911bd846ea96	2025-10-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210211 application number: ANDA210211 ndc (product): 71930-021
Hydrocodone Bitartrate and Acetaminophen	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	NuCare Pharmaceuticals,Inc.	fed1eb12-3e39-1bf9-e053-6294a90afd77	2025-02-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210211 application number: ANDA210211
Hydrocodone Bitartrate and Acetaminophen	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	American Health Packaging	9d76aaf6-e3e0-4ec1-9f20-3d5ab88de630	2025-01-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210211 application number: ANDA210211
Hydrocodone Bitartrate and Acetaminophen	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	NuCare Pharmaceuticals,Inc.	d88e04c1-cd54-6a12-e053-2995a90a22b4	2024-12-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210211 application number: ANDA210211
Hydrocodone Bitartrate and Acetaminophen	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	Bryant Ranch Prepack	2a485efe-a87c-4c55-9e17-7891b2fffb83	2024-09-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210211 application number: ANDA210211
Hydrocodone Bitartrate and Acetaminophen	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	Bryant Ranch Prepack	42a74abc-bdc7-4ea3-a185-029340111730	2024-09-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210211 application number: ANDA210211
Hydrocodone Bitartrate and Acetaminophen	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	NuCare Pharmaceuticals,Inc.	c8d65aab-d6ae-bc69-e053-2a95a90a7b5e	2024-03-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210211 application number: ANDA210211

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
856999	HYDROcodone bitartrate 10 MG / acetaminophen 325 MG Oral Tablet	PSN	09db348f-8396-41b2-b639-608dcfdbccf4	105
856999	acetaminophen 325 MG / hydrocodone bitartrate 10 MG Oral Tablet	SCD	09db348f-8396-41b2-b639-608dcfdbccf4	105
856999	APAP 325 MG / hydrocodone bitartrate 10 MG Oral Tablet	SY	09db348f-8396-41b2-b639-608dcfdbccf4	105
856999	HYDROcodone bitartrate 10 MG / acetaminophen 325 MG Oral Tablet	PSN	42a74abc-bdc7-4ea3-a185-029340111730	103
856999	acetaminophen 325 MG / hydrocodone bitartrate 10 MG Oral Tablet	SCD	42a74abc-bdc7-4ea3-a185-029340111730	103
856999	APAP 325 MG / hydrocodone bitartrate 10 MG Oral Tablet	SY	42a74abc-bdc7-4ea3-a185-029340111730	103
856999	HYDROcodone bitartrate 10 MG / acetaminophen 325 MG Oral Tablet	PSN	c534f784-0e21-4891-8f7e-2dc327b267f1	102
856999	acetaminophen 325 MG / hydrocodone bitartrate 10 MG Oral Tablet	SCD	c534f784-0e21-4891-8f7e-2dc327b267f1	102
856999	APAP 325 MG / hydrocodone bitartrate 10 MG Oral Tablet	SY	c534f784-0e21-4891-8f7e-2dc327b267f1	102
856999	HYDROcodone bitartrate 10 MG / acetaminophen 325 MG Oral Tablet	PSN	fcd2b59e-8087-475e-9e6b-911bd846ea96	8
856999	HYDROcodone bitartrate 10 MG / acetaminophen 325 MG Oral Tablet	PSN	9d76aaf6-e3e0-4ec1-9f20-3d5ab88de630	8
857002	HYDROcodone bitartrate 5 MG / acetaminophen 325 MG Oral Tablet	PSN	9d76aaf6-e3e0-4ec1-9f20-3d5ab88de630	8
857002	HYDROcodone bitartrate 5 MG / acetaminophen 325 MG Oral Tablet	PSN	fcd2b59e-8087-475e-9e6b-911bd846ea96	8
857005	HYDROcodone bitartrate 7.5 MG / acetaminophen 325 MG Oral Tablet	PSN	fcd2b59e-8087-475e-9e6b-911bd846ea96	8
857005	HYDROcodone bitartrate 7.5 MG / acetaminophen 325 MG Oral Tablet	PSN	9d76aaf6-e3e0-4ec1-9f20-3d5ab88de630	8
856999	acetaminophen 325 MG / hydrocodone bitartrate 10 MG Oral Tablet	SCD	9d76aaf6-e3e0-4ec1-9f20-3d5ab88de630	8
856999	acetaminophen 325 MG / hydrocodone bitartrate 10 MG Oral Tablet	SCD	fcd2b59e-8087-475e-9e6b-911bd846ea96	8
857002	acetaminophen 325 MG / hydrocodone bitartrate 5 MG Oral Tablet	SCD	fcd2b59e-8087-475e-9e6b-911bd846ea96	8
857002	acetaminophen 325 MG / hydrocodone bitartrate 5 MG Oral Tablet	SCD	9d76aaf6-e3e0-4ec1-9f20-3d5ab88de630	8
857005	acetaminophen 325 MG / hydrocodone bitartrate 7.5 MG Oral Tablet	SCD	fcd2b59e-8087-475e-9e6b-911bd846ea96	8
857005	acetaminophen 325 MG / hydrocodone bitartrate 7.5 MG Oral Tablet	SCD	9d76aaf6-e3e0-4ec1-9f20-3d5ab88de630	8
856999	APAP 325 MG / hydrocodone bitartrate 10 MG Oral Tablet	SY	fcd2b59e-8087-475e-9e6b-911bd846ea96	8
856999	APAP 325 MG / hydrocodone bitartrate 10 MG Oral Tablet	SY	9d76aaf6-e3e0-4ec1-9f20-3d5ab88de630	8
857002	APAP 325 MG / hydrocodone bitartrate 5 MG Oral Tablet	SY	fcd2b59e-8087-475e-9e6b-911bd846ea96	8
857002	APAP 325 MG / hydrocodone bitartrate 5 MG Oral Tablet	SY	9d76aaf6-e3e0-4ec1-9f20-3d5ab88de630	8
857005	APAP 325 MG / hydrocodone bitartrate 7.5 MG Oral Tablet	SY	9d76aaf6-e3e0-4ec1-9f20-3d5ab88de630	8
857005	APAP 325 MG / hydrocodone bitartrate 7.5 MG Oral Tablet	SY	fcd2b59e-8087-475e-9e6b-911bd846ea96	8
856999	HYDROcodone bitartrate 10 MG / acetaminophen 325 MG Oral Tablet	PSN	446e9f78-4034-5bb4-e063-6394a90ac739	2
856999	HYDROcodone bitartrate 10 MG / acetaminophen 325 MG Oral Tablet	PSN	66e184cd-fa32-431f-b843-9c4bea12593b	2
857002	HYDROcodone bitartrate 5 MG / acetaminophen 325 MG Oral Tablet	PSN	66e184cd-fa32-431f-b843-9c4bea12593b	2
857005	HYDROcodone bitartrate 7.5 MG / acetaminophen 325 MG Oral Tablet	PSN	66e184cd-fa32-431f-b843-9c4bea12593b	2
856999	acetaminophen 325 MG / hydrocodone bitartrate 10 MG Oral Tablet	SCD	66e184cd-fa32-431f-b843-9c4bea12593b	2
856999	acetaminophen 325 MG / hydrocodone bitartrate 10 MG Oral Tablet	SCD	446e9f78-4034-5bb4-e063-6394a90ac739	2
857002	acetaminophen 325 MG / hydrocodone bitartrate 5 MG Oral Tablet	SCD	66e184cd-fa32-431f-b843-9c4bea12593b	2
857005	acetaminophen 325 MG / hydrocodone bitartrate 7.5 MG Oral Tablet	SCD	66e184cd-fa32-431f-b843-9c4bea12593b	2
856999	APAP 325 MG / hydrocodone bitartrate 10 MG Oral Tablet	SY	446e9f78-4034-5bb4-e063-6394a90ac739	2
856999	APAP 325 MG / hydrocodone bitartrate 10 MG Oral Tablet	SY	66e184cd-fa32-431f-b843-9c4bea12593b	2
857002	APAP 325 MG / hydrocodone bitartrate 5 MG Oral Tablet	SY	66e184cd-fa32-431f-b843-9c4bea12593b	2
857005	APAP 325 MG / hydrocodone bitartrate 7.5 MG Oral Tablet	SY	66e184cd-fa32-431f-b843-9c4bea12593b	2
856999	HYDROcodone bitartrate 10 MG / acetaminophen 325 MG Oral Tablet	PSN	e181d8cf-3722-3eb4-e053-2995a90ad35d	1
856999	HYDROcodone bitartrate 10 MG / acetaminophen 325 MG Oral Tablet	PSN	d696662b-e4a4-3474-e053-2995a90a9389	1
856999	acetaminophen 325 MG / hydrocodone bitartrate 10 MG Oral Tablet	SCD	e181d8cf-3722-3eb4-e053-2995a90ad35d	1
856999	acetaminophen 325 MG / hydrocodone bitartrate 10 MG Oral Tablet	SCD	d696662b-e4a4-3474-e053-2995a90a9389	1
856999	APAP 325 MG / hydrocodone bitartrate 10 MG Oral Tablet	SY	e181d8cf-3722-3eb4-e053-2995a90ad35d	1
856999	APAP 325 MG / hydrocodone bitartrate 10 MG Oral Tablet	SY	d696662b-e4a4-3474-e053-2995a90a9389	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71930-021-12	71930002112	100 TABLET in 1 BOTTLE (71930-021-12)	100 tablet	2018-07-13	0000-00-00	No	No	Current
71930-021-13	71930002113	1000 TABLET in 1 BOTTLE (71930-021-13)	1000 tablet	2022-10-06	0000-00-00	No	No	Current
71930-021-52	71930002152	500 TABLET in 1 BOTTLE (71930-021-52)	500 tablet	2018-07-13	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Hydrocodone Bitartrate and Acetaminophen Tablets, USP CII Revised: 01/2024	Bryant Ranch Prepack	2026-03-25	HUMAN PRESCRIPTION DRUG LABEL	105
Hydrocodone Bitartrate and Acetaminophen Tablets, USP CII Revised: 01/2024	Bryant Ranch Prepack	2026-03-23	HUMAN PRESCRIPTION DRUG LABEL	102
Hydrocodone Bitartrate and Acetaminophen Tablets, USP CII Revised: 01/2024	Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	2026-03-10	HUMAN PRESCRIPTION DRUG LABEL	2
Hydrocodone/APAP	Direct_Rx	2026-02-05	HUMAN PRESCRIPTION DRUG LABEL	2
Hydrocodone Bitartrate and Acetaminophen Tablets, USP CII Revised: 01/2024	Eywa Pharma Inc \| WES Pharma Inc.	2025-10-03	Human Prescription Drug Label	8
Hydrocodone Bitartrate and Acetaminophen Tablets, USP CII 8439601/1124 Rx only	American Health Packaging	2025-01-10	HUMAN PRESCRIPTION DRUG LABEL	8
Hydrocodone Bitartrate and Acetaminophen Tablets, USP CII Revised: 01/2024	Bryant Ranch Prepack	2024-09-05	HUMAN PRESCRIPTION DRUG LABEL	103
Hydrocodone Bitartrate and Acetaminophen Tablets, USP CII Revised: April 2020	NuCare Pharmaceuticals,Inc.	2022-06-15	HUMAN PRESCRIPTION DRUG LABEL	1
Hydrocodone Bitartrate and Acetaminophen Tablets, USP CII Revised: April 2020	NuCare Pharmaceuticals,Inc.	2022-01-27	HUMAN PRESCRIPTION DRUG LABEL	1