pentazocine and naloxone

Product NDC: 63304-506
Requested package NDC: 63304-506-01
11-digit product format: 633040506
Labeler code: 63304
Product ID: 63304-506_5ef64a8b-8388-09cf-e063-6294a90a4fd3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: pentazocine and naloxone
Dosage form: TABLET
Route: ORAL
Labeler: Sun Pharmaceutical Industries, Inc.
Application: ANDA075523
Marketing category: ANDA
Marketing start: 2018-07-31
Substance: PENTAZOCINE; NALOXONE HYDROCHLORIDE
Active strength: 50; .5 mg/1; mg/1
Pharmacologic classes: Competitive Opioid Antagonists [MoA], Opioid Antagonist [EPC], Opioid Antagonists [MoA], Partial Opioid Agonist/Antagonist [EPC], Partial Opioid Agonists [MoA]
DEA schedule: CIV
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 44.

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
A075523-001	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	NALOXONE HYDROCHLORIDE; PENTAZOCINE HYDROCHLORIDE	EQ 0.5MG BASE;EQ 50MG BASE	TABLET / ORAL	AB		2000-03-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075523-001	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 · 44 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
2026-10-15 13:18:30	2026-09	A075523-001	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	EQ 0.5MG BASE;EQ 50MG BASE	TABLET / ORAL	AB	2000-03-17	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A075523-001	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	EQ 0.5MG BASE;EQ 50MG BASE	TABLET / ORAL	AB	2000-03-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075523-001	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	EQ 0.5MG BASE;EQ 50MG BASE	TABLET / ORAL	AB	2000-03-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075523-001	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	EQ 0.5MG BASE;EQ 50MG BASE	TABLET / ORAL	AB	2000-03-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075523-001	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	EQ 0.5MG BASE;EQ 50MG BASE	TABLET / ORAL	AB	2000-03-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075523-001	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	EQ 0.5MG BASE;EQ 50MG BASE	TABLET / ORAL	AB	2000-03-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075523-001	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	EQ 0.5MG BASE;EQ 50MG BASE	TABLET / ORAL	AB	2000-03-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075523-001	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	EQ 0.5MG BASE;EQ 50MG BASE	TABLET / ORAL	AB	2000-03-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075523-001	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	EQ 0.5MG BASE;EQ 50MG BASE	TABLET / ORAL	AB	2000-03-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075523-001	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	EQ 0.5MG BASE;EQ 50MG BASE	TABLET / ORAL	AB	2000-03-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075523-001	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	EQ 0.5MG BASE;EQ 50MG BASE	TABLET / ORAL	AB	2000-03-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075523-001	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	EQ 0.5MG BASE;EQ 50MG BASE	TABLET / ORAL	AB	2000-03-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075523-001	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	EQ 0.5MG BASE;EQ 50MG BASE	TABLET / ORAL	AB	2000-03-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075523-001	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	EQ 0.5MG BASE;EQ 50MG BASE	TABLET / ORAL	AB	2000-03-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075523-001	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	EQ 0.5MG BASE;EQ 50MG BASE	TABLET / ORAL	AB	2000-03-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075523-001	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	EQ 0.5MG BASE;EQ 50MG BASE	TABLET / ORAL	AB	2000-03-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075523-001	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	EQ 0.5MG BASE;EQ 50MG BASE	TABLET / ORAL	AB	2000-03-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075523-001	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	EQ 0.5MG BASE;EQ 50MG BASE	TABLET / ORAL	AB	2000-03-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075523-001	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	EQ 0.5MG BASE;EQ 50MG BASE	TABLET / ORAL	AB	2000-03-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075523-001	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	EQ 0.5MG BASE;EQ 50MG BASE	TABLET / ORAL	AB	2000-03-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075523-001	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	EQ 0.5MG BASE;EQ 50MG BASE	TABLET / ORAL	AB	2000-03-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075523-001	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	EQ 0.5MG BASE;EQ 50MG BASE	TABLET / ORAL	AB	2000-03-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075523-001	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	EQ 0.5MG BASE;EQ 50MG BASE	TABLET / ORAL	AB	2000-03-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075523-001	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	EQ 0.5MG BASE;EQ 50MG BASE	TABLET / ORAL	AB	2000-03-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075523-001	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	EQ 0.5MG BASE;EQ 50MG BASE	TABLET / ORAL	AB	2000-03-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075523-001	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	EQ 0.5MG BASE;EQ 50MG BASE	TABLET / ORAL	AB	2000-03-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075523-001	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	EQ 0.5MG BASE;EQ 50MG BASE	TABLET / ORAL	AB	2000-03-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075523-001	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	EQ 0.5MG BASE;EQ 50MG BASE	TABLET / ORAL	AB	2000-03-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075523-001	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	EQ 0.5MG BASE;EQ 50MG BASE	TABLET / ORAL	AB	2000-03-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075523-001	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	EQ 0.5MG BASE;EQ 50MG BASE	TABLET / ORAL	AB	2000-03-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075523-001	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	EQ 0.5MG BASE;EQ 50MG BASE	TABLET / ORAL	AB	2000-03-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075523-001	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	EQ 0.5MG BASE;EQ 50MG BASE	TABLET / ORAL	AB	2000-03-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075523-001	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	EQ 0.5MG BASE;EQ 50MG BASE	TABLET / ORAL	AB	2000-03-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075523-001	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	EQ 0.5MG BASE;EQ 50MG BASE	TABLET / ORAL	AB	2000-03-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075523-001	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	EQ 0.5MG BASE;EQ 50MG BASE	TABLET / ORAL	AB	2000-03-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075523-001	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	EQ 0.5MG BASE;EQ 50MG BASE	TABLET / ORAL	AB	2000-03-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075523-001	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	EQ 0.5MG BASE;EQ 50MG BASE	TABLET / ORAL	AB	2000-03-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075523-001	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	EQ 0.5MG BASE;EQ 50MG BASE	TABLET / ORAL	AB	2000-03-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075523-001	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	EQ 0.5MG BASE;EQ 50MG BASE	TABLET / ORAL	AB	2000-03-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075523-001	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	EQ 0.5MG BASE;EQ 50MG BASE	TABLET / ORAL	AB	2000-03-17	`3a93d1ddd44b…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A075523-001	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A075523-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075523-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075523-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075523-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075523-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075523-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075523-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075523-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075523-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075523-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075523-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075523-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075523-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075523-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075523-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075523-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075523-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075523-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075523-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075523-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075523-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075523-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075523-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075523-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075523-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075523-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075523-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075523-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075523-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075523-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075523-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075523-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075523-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075523-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075523-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075523-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075523-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075523-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075523-001	AB	1	`3a93d1ddd44b…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: pentazocine and naloxone
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PENTAZOCINE	50 mg/1
NALOXONE HYDROCHLORIDE	.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
RP4A60D26L	Internal UNII lookup
F850569PQR	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
312289	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
41ebdaaf-3bbc-419f-b996-0341efc14623	Available on FDA.report

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
63304-506-01	pentazocine and naloxone	100 in 1 BOTTLE	TABLET	100		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63304-506	PENTAZOCINE AND NALOXONE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]	2	Current NDC, Legacy NDC, 1 package rows	20180731_41ebdaaf-3bbc-419f-b996-0341efc14623.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
RP4A60D26L	PENTAZOCINE	359-83-1	PENTAZOCINE
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	41ebdaaf-3bbc-419f-b996-0341efc14623	2
312289	naloxone 0.5 MG / pentazocine 50 MG Oral Tablet	SCD	41ebdaaf-3bbc-419f-b996-0341efc14623	2
312289	naloxone (as naloxone hydrochloride) 0.5 MG / pentazocine (as pentazocine hydrochloride) 50 MG Oral Tablet	SY	41ebdaaf-3bbc-419f-b996-0341efc14623	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63304-506-01	63304050601	100 TABLET in 1 BOTTLE (63304-506-01)	100 tablet	2018-07-31	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PENTAZOCINE AND NALOXONE HYDROCHLORIDE TABLETS USP Analgesic for Oral Use Only Rx only	Sun Pharmaceutical Industries, Inc. \| Ohm Laboratories Inc	2026-10-29	HUMAN PRESCRIPTION DRUG LABEL	3