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 03:21:23

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
68084-291-11	EA - Each	68084-291	b9c42d33-36dc-4e21-a80d-0cb110320eff	1	2013-02-13

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
68084-291	68084-291-11

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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A076264-001	NALTREXONE HYDROCHLORIDE	NALTREXONE HYDROCHLORIDE	25MG	TABLET / ORAL			2002-03-22
A076264-002	NALTREXONE HYDROCHLORIDE	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	2002-03-22
A076264-003	NALTREXONE HYDROCHLORIDE	NALTREXONE HYDROCHLORIDE	100MG	TABLET / ORAL			2002-03-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076264-002	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 4 · 129 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	A076264-001	NALTREXONE HYDROCHLORIDE	25MG	TABLET / ORAL			2002-03-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076264-002	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	2002-03-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076264-003	NALTREXONE HYDROCHLORIDE	100MG	TABLET / ORAL			2002-03-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076264-001	NALTREXONE HYDROCHLORIDE	25MG	TABLET / ORAL			2002-03-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076264-002	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	2002-03-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076264-003	NALTREXONE HYDROCHLORIDE	100MG	TABLET / ORAL			2002-03-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076264-001	NALTREXONE HYDROCHLORIDE	25MG	TABLET / ORAL			2002-03-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076264-002	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	2002-03-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076264-003	NALTREXONE HYDROCHLORIDE	100MG	TABLET / ORAL			2002-03-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076264-001	NALTREXONE HYDROCHLORIDE	25MG	TABLET / ORAL			2002-03-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076264-002	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	2002-03-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076264-003	NALTREXONE HYDROCHLORIDE	100MG	TABLET / ORAL			2002-03-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076264-001	NALTREXONE HYDROCHLORIDE	25MG	TABLET / ORAL			2002-03-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076264-002	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	2002-03-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076264-003	NALTREXONE HYDROCHLORIDE	100MG	TABLET / ORAL			2002-03-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076264-001	NALTREXONE HYDROCHLORIDE	25MG	TABLET / ORAL			2002-03-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076264-002	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	2002-03-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076264-003	NALTREXONE HYDROCHLORIDE	100MG	TABLET / ORAL			2002-03-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076264-001	NALTREXONE HYDROCHLORIDE	25MG	TABLET / ORAL			2002-03-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076264-002	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	2002-03-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076264-003	NALTREXONE HYDROCHLORIDE	100MG	TABLET / ORAL			2002-03-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076264-001	NALTREXONE HYDROCHLORIDE	25MG	TABLET / ORAL			2002-03-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076264-002	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	2002-03-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076264-003	NALTREXONE HYDROCHLORIDE	100MG	TABLET / ORAL			2002-03-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076264-001	NALTREXONE HYDROCHLORIDE	25MG	TABLET / ORAL			2002-03-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076264-002	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	2002-03-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076264-003	NALTREXONE HYDROCHLORIDE	100MG	TABLET / ORAL			2002-03-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076264-001	NALTREXONE HYDROCHLORIDE	25MG	TABLET / ORAL			2002-03-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076264-002	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	2002-03-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076264-003	NALTREXONE HYDROCHLORIDE	100MG	TABLET / ORAL			2002-03-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076264-001	NALTREXONE HYDROCHLORIDE	25MG	TABLET / ORAL			2002-03-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076264-002	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	2002-03-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076264-003	NALTREXONE HYDROCHLORIDE	100MG	TABLET / ORAL			2002-03-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076264-001	NALTREXONE HYDROCHLORIDE	25MG	TABLET / ORAL			2002-03-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076264-002	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	2002-03-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076264-003	NALTREXONE HYDROCHLORIDE	100MG	TABLET / ORAL			2002-03-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076264-001	NALTREXONE HYDROCHLORIDE	25MG	TABLET / ORAL			2002-03-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076264-002	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	2002-03-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076264-003	NALTREXONE HYDROCHLORIDE	100MG	TABLET / ORAL			2002-03-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076264-001	NALTREXONE HYDROCHLORIDE	25MG	TABLET / ORAL			2002-03-22	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 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	A076264-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076264-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076264-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076264-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076264-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076264-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076264-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076264-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076264-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076264-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076264-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076264-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076264-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076264-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076264-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076264-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076264-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076264-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076264-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076264-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076264-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076264-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076264-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076264-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076264-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076264-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076264-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076264-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076264-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076264-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076264-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076264-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076264-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076264-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076264-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076264-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076264-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076264-002	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076264-002	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076264-002	AB	1	`f41ea6bd6efb…`

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
NALTREXONE HYDROCHLORIDE	NALTREXONE HYDROCHLORIDE	American Health Packaging	81e25c6a-81b6-4cfb-91bf-be20c3ae546b	2024-08-05	Warnings, Adverse reactions	Exact identifier ndc (package): 68084-291-11 ndc11 (package): 68084029111

Reported adverse events (FAERS/openFDA)#

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