PENTAZOCINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE

Product NDC: 43386-680
11-digit product format: 433860680
Labeler code: 43386
Product ID: 43386-680_21e7776e-65d0-45fb-a1b2-13f49055ad64
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: pentazocine hydrochloride and naloxone hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Lupin Pharmaceuticals,Inc.
Application: ANDA075735
Marketing category: ANDA
Marketing start: 2011-05-11
Substance: PENTAZOCINE HYDROCHLORIDE; 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: 2026-12-31
Current FDA listing: Yes

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.

Additional Listing Data#

Finished product: Yes
Brand name base: PENTAZOCINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PENTAZOCINE HYDROCHLORIDE	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
A36BXO4PPX	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
017ef042-40aa-44c9-baa8-037f06356845	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
43386-680-01	PENTAZOCINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	100 in 1 BOTTLE	TABLET	100		16
43386-680-05	PENTAZOCINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	500 in 1 BOTTLE	TABLET	500		16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43386-680-01	EA - Each	43386-680	0646b0b8-f913-4fd5-b96d-5eff3d379145	1	2012-07-24

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
NALOXONE HYDROCHLORIDE	ACTIVE INGREDIENT	F850569PQR	PENTAZOCINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE TABLET [GAVIS PHARMACEUTICALS, LLC]	1
PENTAZOCINE HYDROCHLORIDE	ACTIVE INGREDIENT	A36BXO4PPX	PENTAZOCINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE TABLET [DIRECT RX]	1
PENTAZOCINE HYDROCHLORIDE	ACTIVE INGREDIENT	A36BXO4PPX	PENTAZOCINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE TABLET [GAVIS PHARMACEUTICALS, LLC]	1
NALOXONE	ACTIVE MOIETY	36B82AMQ7N	PENTAZOCINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE TABLET [DIRECT RX]	1
NALOXONE	ACTIVE MOIETY	36B82AMQ7N	PENTAZOCINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE TABLET [GAVIS PHARMACEUTICALS, LLC]	1
PENTAZOCINE	ACTIVE MOIETY	RP4A60D26L	PENTAZOCINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE TABLET [GAVIS PHARMACEUTICALS, LLC]	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 [GAVIS PHARMACEUTICALS, LLC]	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
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	PENTAZOCINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE TABLET [GAVIS PHARMACEUTICALS, LLC]	1
DIBASIC CALCIUM PHOSPHATE DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	PENTAZOCINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE TABLET [DIRECT RX]	1
DIBASIC CALCIUM PHOSPHATE DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	PENTAZOCINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE TABLET [GAVIS PHARMACEUTICALS, LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PENTAZOCINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE TABLET [GAVIS PHARMACEUTICALS, LLC]	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 [GAVIS PHARMACEUTICALS, LLC]	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
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	PENTAZOCINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE TABLET [GAVIS PHARMACEUTICALS, LLC]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	PENTAZOCINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE TABLET [DIRECT RX]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	PENTAZOCINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE TABLET [GAVIS PHARMACEUTICALS, LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43386-680	PENTAZOCINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE TABLET [LUPIN PHARMACEUTICALS,INC.]	15	Current NDC, Legacy NDC, 2 package rows	20240316_017ef042-40aa-44c9-baa8-037f06356845.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 ndc (product): 43386-680

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	017ef042-40aa-44c9-baa8-037f06356845	16
312289	naloxone 0.5 MG / pentazocine 50 MG Oral Tablet	SCD	017ef042-40aa-44c9-baa8-037f06356845	16
312289	naloxone (as naloxone hydrochloride) 0.5 MG / pentazocine (as pentazocine hydrochloride) 50 MG Oral Tablet	SY	017ef042-40aa-44c9-baa8-037f06356845	16
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	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
43386-680-01	43386068001	100 TABLET in 1 BOTTLE (43386-680-01)	100 tablet	2011-05-11	0000-00-00	Yes	No	Current
43386-680-05	43386068005	500 TABLET in 1 BOTTLE (43386-680-05)	500 tablet	2011-05-11	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Pentazocine and Naloxone Tablets, USP CIV Revised: August 2025 Analgesic for Oral Use Only	Lupin Pharmaceuticals,Inc. \| Lupin Inc. \| Novel Laboratories, Inc.	2025-08-28	HUMAN PRESCRIPTION DRUG LABEL	16
PENTAZOCINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	DIRECT RX	2016-11-10	HUMAN PRESCRIPTION DRUG LABEL	2