Hydrocodone Bitartrate and Acetaminophen

Product NDC: 71335-9737
Requested package NDC: 71335-9737-5
11-digit product format: 713359737
Labeler code: 71335
Product ID: 71335-9737_68abbbc9-2c1b-4d57-96d2-96ac76fdffdd
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Hydrocodone Bitartrate and Acetaminophen
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA202214
Marketing category: ANDA
Marketing start: 2014-10-06
Substance: ACETAMINOPHEN; HYDROCODONE BITARTRATE
Active strength: 325; 7.5 mg/1; mg/1
Pharmacologic classes: Opioid Agonist [EPC], Opioid Agonists [MoA]
DEA schedule: CII
NDC exclude flag: No
Listing certified through: 2027-12-31
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 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A202214-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	ACETAMINOPHEN; HYDROCODONE BITARTRATE	325MG;5MG	TABLET / ORAL	AA	2013-03-27
A202214-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	ACETAMINOPHEN; HYDROCODONE BITARTRATE	325MG;7.5MG	TABLET / ORAL	AA	2013-03-27
A202214-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	ACETAMINOPHEN; HYDROCODONE BITARTRATE	325MG;10MG	TABLET / ORAL	AA	2013-03-27
A202214-004	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	ACETAMINOPHEN; HYDROCODONE BITARTRATE	300MG;5MG	TABLET / ORAL	AA	2016-03-15
A202214-005	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	ACETAMINOPHEN; HYDROCODONE BITARTRATE	300MG;7.5MG	TABLET / ORAL	AA	2016-03-15
A202214-006	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	ACETAMINOPHEN; HYDROCODONE BITARTRATE	300MG;10MG	TABLET / ORAL	AA	2016-03-15

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-product	TE code
A202214-001	AA
A202214-002	AA
A202214-003	AA
A202214-004	AA
A202214-005	AA
A202214-006	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 7 · 246 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	A202214-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2013-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202214-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2013-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202214-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2013-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202214-004	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;5MG	TABLET / ORAL	AA	2016-03-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202214-005	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;7.5MG	TABLET / ORAL	AA	2016-03-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202214-006	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;10MG	TABLET / ORAL	AA	2016-03-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202214-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2013-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202214-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2013-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202214-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2013-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202214-004	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;5MG	TABLET / ORAL	AA	2016-03-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202214-005	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;7.5MG	TABLET / ORAL	AA	2016-03-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202214-006	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;10MG	TABLET / ORAL	AA	2016-03-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202214-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2013-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202214-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2013-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202214-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2013-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202214-004	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;5MG	TABLET / ORAL	AA	2016-03-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202214-005	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;7.5MG	TABLET / ORAL	AA	2016-03-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202214-006	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;10MG	TABLET / ORAL	AA	2016-03-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202214-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2013-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202214-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2013-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202214-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2013-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202214-004	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;5MG	TABLET / ORAL	AA	2016-03-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202214-005	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;7.5MG	TABLET / ORAL	AA	2016-03-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202214-006	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;10MG	TABLET / ORAL	AA	2016-03-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202214-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2013-03-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202214-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2013-03-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202214-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2013-03-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202214-004	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;5MG	TABLET / ORAL	AA	2016-03-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202214-005	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;7.5MG	TABLET / ORAL	AA	2016-03-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202214-006	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;10MG	TABLET / ORAL	AA	2016-03-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202214-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2013-03-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202214-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2013-03-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202214-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2013-03-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202214-004	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;5MG	TABLET / ORAL	AA	2016-03-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202214-005	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;7.5MG	TABLET / ORAL	AA	2016-03-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202214-006	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;10MG	TABLET / ORAL	AA	2016-03-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202214-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2013-03-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202214-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2013-03-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202214-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2013-03-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202214-004	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG;5MG	TABLET / ORAL	AA	2016-03-15	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 246 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	A202214-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202214-002	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202214-003	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202214-004	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202214-005	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202214-006	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202214-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202214-002	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202214-003	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202214-004	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202214-005	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202214-006	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202214-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202214-002	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202214-003	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202214-004	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202214-005	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202214-006	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202214-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202214-002	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202214-003	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202214-004	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202214-005	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202214-006	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202214-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202214-002	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202214-003	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202214-004	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202214-005	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202214-006	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202214-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202214-002	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202214-003	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202214-004	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202214-005	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202214-006	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202214-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202214-002	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202214-003	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202214-004	AA	1	`2680178bc6a6…`

Additional Listing Data#

Finished product: Yes
Brand name base: Hydrocodone Bitartrate and Acetaminophen
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
HYDROCODONE BITARTRATE	325 mg/1
ACETAMINOPHEN	7.5 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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
5a7fb0e7-eb06-4332-a786-d0051afd1dd9	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
71335-9737-1	Hydrocodone Bitartrate and Acetaminophen	30 in 1 BOTTLE, PLASTIC	TABLET	30	104
71335-9737-2	Hydrocodone Bitartrate and Acetaminophen	15 in 1 BOTTLE, PLASTIC	TABLET	15	104
71335-9737-3	Hydrocodone Bitartrate and Acetaminophen	28 in 1 BOTTLE, PLASTIC	TABLET	28	104
71335-9737-4	Hydrocodone Bitartrate and Acetaminophen	56 in 1 BOTTLE, PLASTIC	TABLET	56	104
71335-9737-5	Hydrocodone Bitartrate and Acetaminophen	60 in 1 BOTTLE, PLASTIC	TABLET	60	104
71335-9737-6	Hydrocodone Bitartrate and Acetaminophen	90 in 1 BOTTLE, PLASTIC	TABLET	90	104
71335-9737-7	Hydrocodone Bitartrate and Acetaminophen	120 in 1 BOTTLE, PLASTIC	TABLET	120	104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71335-9737-5	EA - Each	71335-9737	92c55706-0fbd-4845-8e16-3c43b3a1563e	1	2023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71335-9737	HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [BRYANT RANCH PREPACK]	103	Current NDC, 7 package rows	20250403_5a7fb0e7-eb06-4332-a786-d0051afd1dd9.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 2 · 33 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	425258b6-72d7-e9b5-e063-6394a90a3fc7	2026-06-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202214 application number: ANDA202214
Hydrocodone Bitartrate and Acetaminophen	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	St. Mary's Medical Park Pharmacy	4135fb50-2e77-7365-e063-6294a90a8c43	2026-06-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202214 application number: ANDA202214
Hydrocodone Bitartrate and Acetaminophen	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	Bryant Ranch Prepack	375c3f81-3276-431e-8773-7b189730e9fd	2026-05-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202214 application number: ANDA202214
Hydrocodone Bitartrate and Acetaminophen	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	ST. MARY'S MEDICAL PARK PHARMACY	3d347b9b-1b5c-68c8-e063-6294a90aaa9b	2026-05-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202214 application number: ANDA202214
Hydrocodone Bitartrate and Acetaminophen	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	Bryant Ranch Prepack	8e99994a-83b4-4b1f-9654-4ae373bf2c4d	2026-04-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202214 application number: ANDA202214
Hydrocodone Bitartrate and Acetaminophen	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	Bryant Ranch Prepack	5a7fb0e7-eb06-4332-a786-d0051afd1dd9	2026-04-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202214 application number: ANDA202214 ndc (package): 71335-9737-5 ndc (product): 71335-9737 ndc11 (package): 71335973705
Hydrocodone Bitartrate and Acetaminophen	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	Bryant Ranch Prepack	679b4f87-59df-48d4-a9e6-e78aaeab23ea	2026-04-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202214 application number: ANDA202214
Hydrocodone Bitartrate and Acetaminophen	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	Bryant Ranch Prepack	d3b7f2b3-28c4-4ba5-961f-48e838600be2	2026-04-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202214 application number: ANDA202214
Hydrocodone Bitartrate and Acetaminophen	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	Bryant Ranch Prepack	092f4694-98df-41bd-b37c-afbcda087e56	2026-04-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202214 application number: ANDA202214
Hydrocodone Bitartrate and Acetaminophen	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	Bryant Ranch Prepack	a3cbf0c1-b589-4e4a-b355-01bddb7e4955	2026-04-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202214 application number: ANDA202214
Hydrocodone Bitartrate and Acetaminophen	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	Bryant Ranch Prepack	f7b554ab-2996-4cf0-a498-01cd5ef5df4f	2026-04-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202214 application number: ANDA202214
Hydrocodone Bitartrate and Acetaminophen	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	Bryant Ranch Prepack	5431c1bf-469b-4944-a558-52d098c9b0f0	2026-04-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202214 application number: ANDA202214
Hydrocodone Bitartrate and Acetaminophen	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	Bryant Ranch Prepack	e5d6de20-c195-4b97-963a-2f3832e50b49	2026-04-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202214 application number: ANDA202214
Hydrocodone Bitartrate and Acetaminophen	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	Bryant Ranch Prepack	6fae7c90-1d80-4eb8-bbb8-8f945884f5c6	2026-04-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202214 application number: ANDA202214
Hydrocodone Bitartrate and Acetaminophen	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	Bryant Ranch Prepack	806a981f-85ff-4e58-8ff0-7ab02ed2e5c1	2026-03-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202214 application number: ANDA202214
Hydrocodone Bitartrate and Acetaminophen	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	Cranbury Pharmaceuticals, LLC	d8fe4ae4-bd19-42eb-b74d-f302b3f914ee	2025-12-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202214 application number: ANDA202214
Hydrocodone Bitartrate and Acetaminophen	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	Cranbury Pharmaceuticals, LLC	d4caec6d-4af2-4f1c-9add-c0c948b83b16	2025-12-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202214 application number: ANDA202214
Hydrocodone Bitartrate and Acetaminophen	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	Bryant Ranch Prepack	36bf5e37-9202-4288-8354-9d123fb692d3	2025-10-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202214 application number: ANDA202214
Hydrocodone Bitartrate and Acetaminophen	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	Bryant Ranch Prepack	fa88d7b2-6c8e-4893-bd81-ecd4f2aca493	2025-07-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202214 application number: ANDA202214
Hydrocodone Bitartrate and Acetaminophen	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	Asclemed USA, Inc.	ba7d27eb-952d-4e99-95b9-5b0b2f85794b	2025-04-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202214 application number: ANDA202214

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
857005	HYDROcodone bitartrate 7.5 MG / acetaminophen 325 MG Oral Tablet	PSN	5a7fb0e7-eb06-4332-a786-d0051afd1dd9	104
857005	acetaminophen 325 MG / hydrocodone bitartrate 7.5 MG Oral Tablet	SCD	5a7fb0e7-eb06-4332-a786-d0051afd1dd9	104
857005	APAP 325 MG / hydrocodone bitartrate 7.5 MG Oral Tablet	SY	5a7fb0e7-eb06-4332-a786-d0051afd1dd9	104

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
71335-9737-5	71335973705	60 TABLET in 1 BOTTLE, PLASTIC (71335-9737-5)	60 tablet	2023-06-14	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Hydrocodone Bitartrate and Acetaminophen	Bryant Ranch Prepack	2026-04-09	HUMAN PRESCRIPTION DRUG LABEL	104