National Council for Prescription Drug Programs indexing - billing unit

Manufacturer: National Council for Prescription Drug Programs
Effective date: 2013-02-13
Label type: Indexing - Billing Unit
Version: 1
Source: full-release
Hydrated at: 2026-06-05 03:22:29

Label at a glance#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
53746-117-01	EA - Each	53746-117	c82e4407-7126-43fb-abc8-e217499e4c2b	1	2013-02-13

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
53746-117	53746-117-01

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A076642-001	HYDROCODONE BITARTRATE AND IBUPROFEN	HYDROCODONE BITARTRATE; IBUPROFEN	7.5MG;200MG	TABLET / ORAL	AB	RS	2004-10-12
A076642-002	HYDROCODONE BITARTRATE AND IBUPROFEN	HYDROCODONE BITARTRATE; IBUPROFEN	5MG;200MG	TABLET / ORAL			2004-03-18
A076642-003	REPREXAIN	HYDROCODONE BITARTRATE; IBUPROFEN	2.5MG;200MG	TABLET / ORAL			2007-10-19
A076642-004	REPREXAIN	HYDROCODONE BITARTRATE; IBUPROFEN	10MG;200MG	TABLET / ORAL			2007-10-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076642-001	AB

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 5 · 172 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
2026-09-14 22:38:34	2026-08	A076642-001	HYDROCODONE BITARTRATE AND IBUPROFEN	7.5MG;200MG	TABLET / ORAL	AB	RS	2004-10-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076642-002	HYDROCODONE BITARTRATE AND IBUPROFEN	5MG;200MG	TABLET / ORAL			2004-03-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076642-003	REPREXAIN	2.5MG;200MG	TABLET / ORAL			2007-10-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076642-004	REPREXAIN	10MG;200MG	TABLET / ORAL			2007-10-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076642-001	HYDROCODONE BITARTRATE AND IBUPROFEN	7.5MG;200MG	TABLET / ORAL	AB	RS	2004-10-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076642-002	HYDROCODONE BITARTRATE AND IBUPROFEN	5MG;200MG	TABLET / ORAL			2004-03-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076642-003	REPREXAIN	2.5MG;200MG	TABLET / ORAL			2007-10-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076642-004	REPREXAIN	10MG;200MG	TABLET / ORAL			2007-10-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076642-001	HYDROCODONE BITARTRATE AND IBUPROFEN	7.5MG;200MG	TABLET / ORAL	AB	RS	2004-10-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076642-002	HYDROCODONE BITARTRATE AND IBUPROFEN	5MG;200MG	TABLET / ORAL			2004-03-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076642-003	REPREXAIN	2.5MG;200MG	TABLET / ORAL			2007-10-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076642-004	REPREXAIN	10MG;200MG	TABLET / ORAL			2007-10-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076642-001	HYDROCODONE BITARTRATE AND IBUPROFEN	7.5MG;200MG	TABLET / ORAL	AB	RS	2004-10-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076642-002	HYDROCODONE BITARTRATE AND IBUPROFEN	5MG;200MG	TABLET / ORAL			2004-03-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076642-003	REPREXAIN	2.5MG;200MG	TABLET / ORAL			2007-10-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076642-004	REPREXAIN	10MG;200MG	TABLET / ORAL			2007-10-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076642-001	HYDROCODONE BITARTRATE AND IBUPROFEN	7.5MG;200MG	TABLET / ORAL	AB	RS	2004-10-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076642-002	HYDROCODONE BITARTRATE AND IBUPROFEN	5MG;200MG	TABLET / ORAL			2004-03-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076642-003	REPREXAIN	2.5MG;200MG	TABLET / ORAL			2007-10-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076642-004	REPREXAIN	10MG;200MG	TABLET / ORAL			2007-10-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076642-001	HYDROCODONE BITARTRATE AND IBUPROFEN	7.5MG;200MG	TABLET / ORAL	AB	RS	2004-10-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076642-002	HYDROCODONE BITARTRATE AND IBUPROFEN	5MG;200MG	TABLET / ORAL			2004-03-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076642-003	REPREXAIN	2.5MG;200MG	TABLET / ORAL			2007-10-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076642-004	REPREXAIN	10MG;200MG	TABLET / ORAL			2007-10-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076642-001	HYDROCODONE BITARTRATE AND IBUPROFEN	7.5MG;200MG	TABLET / ORAL	AB	RS	2004-10-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076642-002	HYDROCODONE BITARTRATE AND IBUPROFEN	5MG;200MG	TABLET / ORAL			2004-03-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076642-003	REPREXAIN	2.5MG;200MG	TABLET / ORAL			2007-10-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076642-004	REPREXAIN	10MG;200MG	TABLET / ORAL			2007-10-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076642-001	HYDROCODONE BITARTRATE AND IBUPROFEN	7.5MG;200MG	TABLET / ORAL	AB	RS	2004-10-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076642-002	HYDROCODONE BITARTRATE AND IBUPROFEN	5MG;200MG	TABLET / ORAL			2004-03-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076642-003	REPREXAIN	2.5MG;200MG	TABLET / ORAL			2007-10-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076642-004	REPREXAIN	10MG;200MG	TABLET / ORAL			2007-10-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076642-001	HYDROCODONE BITARTRATE AND IBUPROFEN	7.5MG;200MG	TABLET / ORAL	AB	RS	2004-10-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076642-002	HYDROCODONE BITARTRATE AND IBUPROFEN	5MG;200MG	TABLET / ORAL	AB		2004-03-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076642-003	REPREXAIN	2.5MG;200MG	TABLET / ORAL			2007-10-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076642-004	REPREXAIN	10MG;200MG	TABLET / ORAL			2007-10-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076642-001	HYDROCODONE BITARTRATE AND IBUPROFEN	7.5MG;200MG	TABLET / ORAL	AB	RS	2004-10-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076642-002	HYDROCODONE BITARTRATE AND IBUPROFEN	5MG;200MG	TABLET / ORAL	AB		2004-03-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076642-003	REPREXAIN	2.5MG;200MG	TABLET / ORAL			2007-10-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076642-004	REPREXAIN	10MG;200MG	TABLET / ORAL			2007-10-19	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A076642-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076642-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076642-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076642-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076642-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076642-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076642-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076642-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076642-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076642-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076642-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076642-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076642-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076642-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076642-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076642-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076642-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076642-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076642-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076642-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076642-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076642-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076642-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076642-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076642-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076642-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076642-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076642-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076642-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076642-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076642-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076642-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076642-004	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076642-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076642-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076642-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A076642-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076642-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076642-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076642-001	AB	1	`5aa47cf7b7d7…`

openFDA label cross-check#

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

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

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydrocodone Bitartrate and Ibuprofen	HYDROCODONE BITARTRATE AND IBUPROFEN	Amneal Pharmaceuticals of New York LLC	abc33718-4e88-43ea-9ffa-2b04ffc812ef	2025-11-21	Boxed warning, Warnings, Adverse reactions	Exact identifier ndc (package): 53746-117-01 ndc11 (package): 53746011701

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.