Pentazocine and naloxone

Product NDC: 68387-531
11-digit product format: 683870531
Labeler code: 68387
Product ID: 68387-531_49cd8e11-2282-4c5b-bb4f-95526a9e2d6b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: PENTAZOCINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
Dosage form: TABLET
Route: ORAL
Labeler: Keltman Pharmaceuticals Inc.
Application: ANDA074736
Marketing category: ANDA
Marketing start: 2009-07-21
Marketing end: 0000-00-00
Substance: PENTAZOCINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
Active strength: 50 mg/1; mg/1
Pharmacologic classes: Competitive Opioid Antagonists [MoA],Partial Opioid Agonist/Antagonist [EPC],Partial Opioid Agonists [MoA],Opioid Antagonist [EPC],Opioid Antagonists [MoA]
NDC exclude flag: E
Listing certified through: 2017-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	68387-531		I	Inactivated by FDA	2026-10-05
excluded package	package	68387-531	68387-531-12	I	Inactivated by FDA	2026-10-05
excluded package	package	68387-531	68387-531-30	I	Inactivated by FDA	2026-10-05
excluded package	package	68387-531	68387-531-60	I	Inactivated by FDA	2026-10-05

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 2 · 88 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68387-531-12	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68387-531-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68387-531-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68387-531-12	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68387-531-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68387-531-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68387-531-12	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68387-531-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68387-531-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68387-531-12	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68387-531-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68387-531-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68387-531-12	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68387-531-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68387-531-60	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68387-531-12	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68387-531-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68387-531-60	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68387-531-12	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68387-531-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68387-531-60	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68387-531-12	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68387-531-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68387-531-60	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68387-531-12	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68387-531-30	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68387-531-60	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68387-531-12	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68387-531-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68387-531-60	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68387-531-12	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68387-531-30	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68387-531-60	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68387-531-12	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68387-531-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68387-531-60	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	68387-531-12	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	68387-531-30	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	68387-531-60	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	68387-531-12	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	68387-531-30	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	68387-531-60	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	68387-531-12	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	68387-531-30	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	68387-531-60	`1332a3947898…`	`d4bfe170f9cd…`

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

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
A074736-001	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	NALOXONE HYDROCHLORIDE; PENTAZOCINE HYDROCHLORIDE	EQ 0.5MG BASE;EQ 50MG BASE	TABLET / ORAL	AB	RS	1997-01-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A074736-001	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 2 · 43 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	A074736-001	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	EQ 0.5MG BASE;EQ 50MG BASE	TABLET / ORAL	AB	RS	1997-01-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A074736-001	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	EQ 0.5MG BASE;EQ 50MG BASE	TABLET / ORAL	AB	RS	1997-01-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074736-001	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	EQ 0.5MG BASE;EQ 50MG BASE	TABLET / ORAL	AB	RS	1997-01-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074736-001	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	EQ 0.5MG BASE;EQ 50MG BASE	TABLET / ORAL	AB	RS	1997-01-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074736-001	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	EQ 0.5MG BASE;EQ 50MG BASE	TABLET / ORAL	AB	RS	1997-01-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074736-001	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	EQ 0.5MG BASE;EQ 50MG BASE	TABLET / ORAL	AB	RS	1997-01-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074736-001	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	EQ 0.5MG BASE;EQ 50MG BASE	TABLET / ORAL	AB	RS	1997-01-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074736-001	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	EQ 0.5MG BASE;EQ 50MG BASE	TABLET / ORAL	AB	RS	1997-01-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074736-001	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	EQ 0.5MG BASE;EQ 50MG BASE	TABLET / ORAL	AB	RS	1997-01-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074736-001	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	EQ 0.5MG BASE;EQ 50MG BASE	TABLET / ORAL	AB	RS	1997-01-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074736-001	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	EQ 0.5MG BASE;EQ 50MG BASE	TABLET / ORAL	AB	RS	1997-01-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074736-001	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	EQ 0.5MG BASE;EQ 50MG BASE	TABLET / ORAL	AB	RS	1997-01-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074736-001	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	EQ 0.5MG BASE;EQ 50MG BASE	TABLET / ORAL	AB	RS	1997-01-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074736-001	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	EQ 0.5MG BASE;EQ 50MG BASE	TABLET / ORAL	AB	RS	1997-01-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074736-001	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	EQ 0.5MG BASE;EQ 50MG BASE	TABLET / ORAL	AB	RS	1997-01-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074736-001	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	EQ 0.5MG BASE;EQ 50MG BASE	TABLET / ORAL	AB	RS	1997-01-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074736-001	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	EQ 0.5MG BASE;EQ 50MG BASE	TABLET / ORAL	AB	RS	1997-01-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074736-001	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	EQ 0.5MG BASE;EQ 50MG BASE	TABLET / ORAL	AB	RS	1997-01-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074736-001	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	EQ 0.5MG BASE;EQ 50MG BASE	TABLET / ORAL	AB	RS	1997-01-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074736-001	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	EQ 0.5MG BASE;EQ 50MG BASE	TABLET / ORAL	AB	RS	1997-01-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074736-001	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	EQ 0.5MG BASE;EQ 50MG BASE	TABLET / ORAL	AB	RS	1997-01-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074736-001	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	EQ 0.5MG BASE;EQ 50MG BASE	TABLET / ORAL	AB	RS	1997-01-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074736-001	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	EQ 0.5MG BASE;EQ 50MG BASE	TABLET / ORAL	AB	RS	1997-01-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074736-001	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	EQ 0.5MG BASE;EQ 50MG BASE	TABLET / ORAL	AB	RS	1997-01-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074736-001	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	EQ 0.5MG BASE;EQ 50MG BASE	TABLET / ORAL	AB	RS	1997-01-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074736-001	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	EQ 0.5MG BASE;EQ 50MG BASE	TABLET / ORAL	AB	RS	1997-01-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074736-001	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	EQ 0.5MG BASE;EQ 50MG BASE	TABLET / ORAL	AB	RS	1997-01-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074736-001	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	EQ 0.5MG BASE;EQ 50MG BASE	TABLET / ORAL	AB	RS	1997-01-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074736-001	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	EQ 0.5MG BASE;EQ 50MG BASE	TABLET / ORAL	AB	RS	1997-01-21	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074736-001	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	EQ 0.5MG BASE;EQ 50MG BASE	TABLET / ORAL	AB	RS	1997-01-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074736-001	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	EQ 0.5MG BASE;EQ 50MG BASE	TABLET / ORAL	AB	RS	1997-01-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074736-001	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	EQ 0.5MG BASE;EQ 50MG BASE	TABLET / ORAL	AB	RS	1997-01-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074736-001	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	EQ 0.5MG BASE;EQ 50MG BASE	TABLET / ORAL	AB	RS	1997-01-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074736-001	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	EQ 0.5MG BASE;EQ 50MG BASE	TABLET / ORAL	AB	RS	1997-01-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074736-001	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	EQ 0.5MG BASE;EQ 50MG BASE	TABLET / ORAL	AB	RS	1997-01-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074736-001	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	EQ 0.5MG BASE;EQ 50MG BASE	TABLET / ORAL	AB	RS	1997-01-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074736-001	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	EQ 0.5MG BASE;EQ 50MG BASE	TABLET / ORAL	AB	RS	1997-01-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074736-001	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	EQ 0.5MG BASE;EQ 50MG BASE	TABLET / ORAL	AB	RS	1997-01-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074736-001	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	EQ 0.5MG BASE;EQ 50MG BASE	TABLET / ORAL	AB	RS	1997-01-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074736-001	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	EQ 0.5MG BASE;EQ 50MG BASE	TABLET / ORAL	AB	RS	1997-01-21	`f41ea6bd6efb…`

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	A074736-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A074736-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074736-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074736-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074736-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074736-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074736-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074736-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074736-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074736-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074736-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074736-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074736-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074736-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074736-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074736-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074736-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074736-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074736-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074736-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074736-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074736-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074736-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074736-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074736-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074736-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074736-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074736-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074736-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074736-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074736-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074736-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074736-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074736-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074736-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074736-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074736-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074736-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074736-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074736-001	AB	1	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c955d208-c333-9bd7-be34-d7e12986d44e	Product name	6	20250626
e5f98bfa-66d5-4c3a-b22d-9543d3bee304	Product name	1	20250204
caa6391e-3db3-c912-335f-61b5fc00aa12	Product name	9	20240110
65a3bc34-04ff-4cf1-aad9-c7d92a062f6d	Product name	1	20231003
e951cdf3-f269-4d97-a7d5-c1c3d7283a7d	Product name	3	20230313
ab841ac7-728a-4fc9-be0a-35b96cecbf39	Product name	4	20230306
f327b80c-8fa2-404b-838a-df3eec141cf2	Product name	1	20221212
d4aa2fcf-79c3-4b5f-a00e-1a8e26e00119	Product name	1	20220511
b871fccd-1de6-4c7f-b9e5-045304641ee6	Product name	8	20220118
43b1efe2-1425-4b3e-b3a2-57d40f8478b9	Product name	1	20211026
4c23a34c-e8fc-424c-8fa0-ee064ba6eaef	Product name	1	20170706
0b8c7273-1da3-495f-909a-7cf1e96d2361	Product name	1	20161212
3df867ed-9d48-45cf-bded-1394beaea0b1	Product name	3	20161206
8a245632-e24f-4ccc-b671-995d89c96ebc	Product name	1	20141203
35c9f831-b55b-8fa5-36b8-614b5af2a2ab	Product name	1	20140508
96c5169b-5b9d-547d-bf22-d688d91866e4	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68387-531-12	2019-10-21	C162847	48780-1	956f9ecf-df35-621f-e053-dbdaa90a74ad	Pentazocine and Naloxone Hydrochlorides Tablets USP Rx only
68387-531-30	2019-10-21	C162847	48780-1	956f9ecf-df35-621f-e053-dbdaa90a74ad	Pentazocine and Naloxone Hydrochlorides Tablets USP Rx only
68387-531-60	2019-10-21	C162847	48780-1	956f9ecf-df35-621f-e053-dbdaa90a74ad	Pentazocine and Naloxone Hydrochlorides Tablets USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68387-531-12	Pentazocine and naloxone	120 in 1 BOTTLE, PLASTIC	TABLET	120	1
68387-531-30	Pentazocine and naloxone	30 in 1 BOTTLE, PLASTIC	TABLET	30	1
68387-531-60	Pentazocine and naloxone	60 in 1 BOTTLE, PLASTIC	TABLET	60	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68387-531-12	EA - Each	68387-531	d6ddd52a-310d-401d-8836-b01d2372ee61	1	2012-07-24
68387-531-30	EA - Each	68387-531	760b9a70-20fe-4cdb-8bb7-ceaeeaea11f1	1	2012-07-24
68387-531-60	EA - Each	68387-531	9275034c-891d-4d87-9d1e-5eb042c1b7dd	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
NALOXONE HYDROCHLORIDE	ACTIVE INGREDIENT	F850569PQR	PENTAZOCINE AND NALOXONE (PENTAZOCINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE) TABLET [KELTMAN PHARMACEUTICALS INC.]	1
PENTAZOCINE HYDROCHLORIDE	ACTIVE INGREDIENT	A36BXO4PPX	PENTAZOCINE AND NALOXONE (PENTAZOCINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE) TABLET [KELTMAN PHARMACEUTICALS INC.]	1
NALOXONE	ACTIVE MOIETY	36B82AMQ7N	PENTAZOCINE AND NALOXONE (PENTAZOCINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE) TABLET [KELTMAN PHARMACEUTICALS INC.]	1
PENTAZOCINE	ACTIVE MOIETY	RP4A60D26L	PENTAZOCINE AND NALOXONE (PENTAZOCINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE) TABLET [KELTMAN PHARMACEUTICALS INC.]	1
ANHYDROUS DIBASIC CALCIUM PHOSPHATE	INACTIVE INGREDIENT	L11K75P92J	PENTAZOCINE AND NALOXONE (PENTAZOCINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE) TABLET [KELTMAN PHARMACEUTICALS INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	PENTAZOCINE AND NALOXONE (PENTAZOCINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE) TABLET [KELTMAN PHARMACEUTICALS INC.]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	PENTAZOCINE AND NALOXONE (PENTAZOCINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE) TABLET [KELTMAN PHARMACEUTICALS INC.]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	PENTAZOCINE AND NALOXONE (PENTAZOCINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE) TABLET [KELTMAN PHARMACEUTICALS INC.]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	PENTAZOCINE AND NALOXONE (PENTAZOCINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE) TABLET [KELTMAN PHARMACEUTICALS INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PENTAZOCINE AND NALOXONE (PENTAZOCINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE) TABLET [KELTMAN PHARMACEUTICALS INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	PENTAZOCINE AND NALOXONE (PENTAZOCINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE) TABLET [KELTMAN PHARMACEUTICALS INC.]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	PENTAZOCINE AND NALOXONE (PENTAZOCINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE) TABLET [KELTMAN PHARMACEUTICALS INC.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	PENTAZOCINE AND NALOXONE (PENTAZOCINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE) TABLET [KELTMAN PHARMACEUTICALS INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68387-531	PENTAZOCINE AND NALOXONE (PENTAZOCINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE) TABLET [KELTMAN PHARMACEUTICALS INC.]	1	Legacy NDC, 3 package rows	20100722_05a17f16-c982-4a54-80cd-079959ab49a7.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pentazocine and naloxone	PENTAZOCINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	Actavis Pharma, Inc.	a28450a0-ac93-4235-b9a6-58cdf24773cb	2026-06-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074736 application number: ANDA074736

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
A36BXO4PPX	PENTAZOCINE HYDROCHLORIDE	64024-15-3	PENTAZOCINE HYDROCHLORIDE
F850569PQR	NALOXONE HYDROCHLORIDE	357-08-4	NALOXONE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
312289	pentazocine 50 MG / naloxone 0.5 MG Oral Tablet	PSN	05a17f16-c982-4a54-80cd-079959ab49a7	1
312289	naloxone 0.5 MG / pentazocine 50 MG Oral Tablet	SCD	05a17f16-c982-4a54-80cd-079959ab49a7	1
312289	naloxone (as naloxone hydrochloride) 0.5 MG / pentazocine (as pentazocine hydrochloride) 50 MG Oral Tablet	SY	05a17f16-c982-4a54-80cd-079959ab49a7	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
68387-531-12	68387053112	120 in 1 BOTTLE, PLASTIC	Historical
68387-531-30	68387053130	30 in 1 BOTTLE, PLASTIC	Historical
68387-531-60	68387053160	60 in 1 BOTTLE, PLASTIC	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Pentazocine and Naloxone Hydrochlorides Tablets USP Rx only	Keltman Pharmaceuticals Inc. \| Sandhills Packaging	2010-07-20	HUMAN PRESCRIPTION DRUG LABEL	1