PENTAZOCINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE

Product NDC: 61919-556
11-digit product format: 619190556
Labeler code: 61919
Product ID: 61919-556_40f9338f-419e-19a8-e054-00144ff8d46c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: PENTAZOCINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
Dosage form: TABLET
Route: ORAL
Labeler: DIRECT RX
Application: ANDA075735
Marketing category: ANDA
Marketing start: 2014-01-01
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]
DEA schedule: CIV
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	61919-556		U	Excluded because listing certification expired		2026-10-05
excluded package	package	61919-556	61919-556-30	U	Excluded because listing certification expired		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 1 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		U	Excluded because listing certification expired	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61919-556-30	U	Excluded because listing certification expired	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		U	Excluded because listing certification expired	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61919-556-30	U	Excluded because listing certification expired	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		U	Excluded because listing certification expired	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61919-556-30	U	Excluded because listing certification expired	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		U	Excluded because listing certification expired	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61919-556-30	U	Excluded because listing certification expired	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		U	Excluded because listing certification expired	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61919-556-30	U	Excluded because listing certification expired	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		U	Excluded because listing certification expired	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61919-556-30	U	Excluded because listing certification expired	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61919-556-30	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61919-556-30	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61919-556-30	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		U	Excluded because listing certification expired	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	61919-556-30	U	Excluded because listing certification expired	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		U	Excluded because listing certification expired	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	61919-556-30	U	Excluded because listing certification expired	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		U	Excluded because listing certification expired	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	61919-556-30	U	Excluded because listing certification expired	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		U	Excluded because listing certification expired	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	61919-556-30	U	Excluded because listing certification expired	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		U	Excluded because listing certification expired	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	61919-556-30	U	Excluded because listing certification expired	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		U	Excluded because listing certification expired	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	61919-556-30	U	Excluded because listing certification expired	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		U	Excluded because listing certification expired	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	61919-556-30	U	Excluded because listing certification expired	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		U	Excluded because listing certification expired	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	61919-556-30	U	Excluded because listing certification expired	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		U	Excluded because listing certification expired	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	61919-556-30	U	Excluded because listing certification expired	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		U	Excluded because listing certification expired	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	61919-556-30	U	Excluded because listing certification expired	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	61919-556-30	E	Excluded after deficient or non-compliant submission was not corrected	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	61919-556-30	E	Excluded after deficient or non-compliant submission was not corrected	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	61919-556-30	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

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
A075735-001	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	NALOXONE HYDROCHLORIDE; PENTAZOCINE HYDROCHLORIDE	EQ 0.5MG BASE;EQ 50MG BASE	TABLET / ORAL	AB		2001-07-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075735-001	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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A075735-001	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	EQ 0.5MG BASE;EQ 50MG BASE	TABLET / ORAL	AB	2001-07-11	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075735-001	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	EQ 0.5MG BASE;EQ 50MG BASE	TABLET / ORAL	AB	2001-07-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075735-001	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	EQ 0.5MG BASE;EQ 50MG BASE	TABLET / ORAL	AB	2001-07-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075735-001	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	EQ 0.5MG BASE;EQ 50MG BASE	TABLET / ORAL	AB	2001-07-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075735-001	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	EQ 0.5MG BASE;EQ 50MG BASE	TABLET / ORAL	AB	2001-07-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075735-001	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	EQ 0.5MG BASE;EQ 50MG BASE	TABLET / ORAL	AB	2001-07-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075735-001	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	EQ 0.5MG BASE;EQ 50MG BASE	TABLET / ORAL	AB	2001-07-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075735-001	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	EQ 0.5MG BASE;EQ 50MG BASE	TABLET / ORAL	AB	2001-07-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075735-001	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	EQ 0.5MG BASE;EQ 50MG BASE	TABLET / ORAL	AB	2001-07-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075735-001	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	EQ 0.5MG BASE;EQ 50MG BASE	TABLET / ORAL	AB	2001-07-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075735-001	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	EQ 0.5MG BASE;EQ 50MG BASE	TABLET / ORAL	AB	2001-07-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075735-001	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	EQ 0.5MG BASE;EQ 50MG BASE	TABLET / ORAL	AB	2001-07-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075735-001	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	EQ 0.5MG BASE;EQ 50MG BASE	TABLET / ORAL	AB	2001-07-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075735-001	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	EQ 0.5MG BASE;EQ 50MG BASE	TABLET / ORAL	AB	2001-07-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075735-001	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	EQ 0.5MG BASE;EQ 50MG BASE	TABLET / ORAL	AB	2001-07-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075735-001	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	EQ 0.5MG BASE;EQ 50MG BASE	TABLET / ORAL	AB	2001-07-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075735-001	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	EQ 0.5MG BASE;EQ 50MG BASE	TABLET / ORAL	AB	2001-07-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075735-001	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	EQ 0.5MG BASE;EQ 50MG BASE	TABLET / ORAL	AB	2001-07-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075735-001	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	EQ 0.5MG BASE;EQ 50MG BASE	TABLET / ORAL	AB	2001-07-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075735-001	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	EQ 0.5MG BASE;EQ 50MG BASE	TABLET / ORAL	AB	2001-07-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075735-001	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	EQ 0.5MG BASE;EQ 50MG BASE	TABLET / ORAL	AB	2001-07-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075735-001	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	EQ 0.5MG BASE;EQ 50MG BASE	TABLET / ORAL	AB	2001-07-11	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075735-001	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	EQ 0.5MG BASE;EQ 50MG BASE	TABLET / ORAL	AB	2001-07-11	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075735-001	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	EQ 0.5MG BASE;EQ 50MG BASE	TABLET / ORAL	AB	2001-07-11	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075735-001	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	EQ 0.5MG BASE;EQ 50MG BASE	TABLET / ORAL	AB	2001-07-11	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075735-001	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	EQ 0.5MG BASE;EQ 50MG BASE	TABLET / ORAL	AB	2001-07-11	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075735-001	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	EQ 0.5MG BASE;EQ 50MG BASE	TABLET / ORAL	AB	2001-07-11	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075735-001	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	EQ 0.5MG BASE;EQ 50MG BASE	TABLET / ORAL	AB	2001-07-11	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075735-001	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	EQ 0.5MG BASE;EQ 50MG BASE	TABLET / ORAL	AB	2001-07-11	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075735-001	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	EQ 0.5MG BASE;EQ 50MG BASE	TABLET / ORAL	AB	2001-07-11	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075735-001	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	EQ 0.5MG BASE;EQ 50MG BASE	TABLET / ORAL	AB	2001-07-11	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075735-001	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	EQ 0.5MG BASE;EQ 50MG BASE	TABLET / ORAL	AB	2001-07-11	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075735-001	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	EQ 0.5MG BASE;EQ 50MG BASE	TABLET / ORAL	AB	2001-07-11	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075735-001	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	EQ 0.5MG BASE;EQ 50MG BASE	TABLET / ORAL	AB	2001-07-11	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075735-001	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	EQ 0.5MG BASE;EQ 50MG BASE	TABLET / ORAL	AB	2001-07-11	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075735-001	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	EQ 0.5MG BASE;EQ 50MG BASE	TABLET / ORAL	AB	2001-07-11	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075735-001	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	EQ 0.5MG BASE;EQ 50MG BASE	TABLET / ORAL	AB	2001-07-11	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075735-001	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	EQ 0.5MG BASE;EQ 50MG BASE	TABLET / ORAL	AB	2001-07-11	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075735-001	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	EQ 0.5MG BASE;EQ 50MG BASE	TABLET / ORAL	AB	2001-07-11	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075735-001	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	EQ 0.5MG BASE;EQ 50MG BASE	TABLET / ORAL	AB	2001-07-11	`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	A075735-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075735-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075735-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075735-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075735-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075735-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075735-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075735-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075735-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075735-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075735-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075735-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075735-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075735-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075735-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075735-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075735-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075735-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075735-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075735-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075735-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075735-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075735-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075735-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075735-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075735-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075735-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075735-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075735-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075735-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075735-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075735-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075735-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075735-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075735-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075735-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075735-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075735-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075735-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075735-001	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61919-556-30	PENTAZOCINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	30 in 1 BOTTLE	TABLET	30		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61919-556-30	EA - Each	61919-556	b8ab8195-d9e6-4123-8487-7089b1d2912e	1	2015-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
NALOXONE HYDROCHLORIDE	ACTIVE INGREDIENT	F850569PQR	PENTAZOCINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE TABLET [DIRECT RX]	1
PENTAZOCINE HYDROCHLORIDE	ACTIVE INGREDIENT	A36BXO4PPX	PENTAZOCINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE TABLET [DIRECT RX]	1
NALOXONE	ACTIVE MOIETY	36B82AMQ7N	PENTAZOCINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE TABLET [DIRECT RX]	1
PENTAZOCINE	ACTIVE MOIETY	RP4A60D26L	PENTAZOCINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE TABLET [DIRECT RX]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	PENTAZOCINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE TABLET [DIRECT RX]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	PENTAZOCINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE TABLET [DIRECT RX]	1
DIBASIC CALCIUM PHOSPHATE DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	PENTAZOCINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE TABLET [DIRECT RX]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PENTAZOCINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE TABLET [DIRECT RX]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	PENTAZOCINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE TABLET [DIRECT RX]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	PENTAZOCINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE TABLET [DIRECT RX]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	PENTAZOCINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE TABLET [DIRECT RX]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61919-556	PENTAZOCINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE TABLET [DIRECT RX]	2	Legacy NDC, 1 package rows	20161115_0967a6ed-138c-4465-9d81-fea67c00749b.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 HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	PENTAZOCINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	Lupin Pharmaceuticals,Inc.	017ef042-40aa-44c9-baa8-037f06356845	2025-08-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075735 application number: ANDA075735

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	0967a6ed-138c-4465-9d81-fea67c00749b	2
312289	naloxone 0.5 MG / pentazocine 50 MG Oral Tablet	SCD	0967a6ed-138c-4465-9d81-fea67c00749b	2
312289	naloxone (as naloxone hydrochloride) 0.5 MG / pentazocine (as pentazocine hydrochloride) 50 MG Oral Tablet	SY	0967a6ed-138c-4465-9d81-fea67c00749b	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
61919-556-30	61919055630	30 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PENTAZOCINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	DIRECT RX	2016-11-10	HUMAN PRESCRIPTION DRUG LABEL	2