pentazocine and naloxone

Product NDC
63304-506
11-digit product format
633040506
Labeler code
63304
Product ID
63304-506_48ee2bd7-f7c9-4bf8-8932-ba9065c64cf3
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
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A075523-001NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDENALOXONE HYDROCHLORIDE; PENTAZOCINE HYDROCHLORIDEEQ 0.5MG BASE;EQ 50MG BASETABLET / ORALAB2000-03-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A075523-001AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A075523-001NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDEEQ 0.5MG BASE;EQ 50MG BASETABLET / ORALAB2000-03-1784e616aacf4f…
2026-08-18 06:07:402026-07A075523-001NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDEEQ 0.5MG BASE;EQ 50MG BASETABLET / ORALAB2000-03-17caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075523-001NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDEEQ 0.5MG BASE;EQ 50MG BASETABLET / ORALAB2000-03-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075523-001NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDEEQ 0.5MG BASE;EQ 50MG BASETABLET / ORALAB2000-03-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A075523-001NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDEEQ 0.5MG BASE;EQ 50MG BASETABLET / ORALAB2000-03-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075523-001NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDEEQ 0.5MG BASE;EQ 50MG BASETABLET / ORALAB2000-03-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075523-001NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDEEQ 0.5MG BASE;EQ 50MG BASETABLET / ORALAB2000-03-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075523-001NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDEEQ 0.5MG BASE;EQ 50MG BASETABLET / ORALAB2000-03-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075523-001NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDEEQ 0.5MG BASE;EQ 50MG BASETABLET / ORALAB2000-03-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075523-001NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDEEQ 0.5MG BASE;EQ 50MG BASETABLET / ORALAB2000-03-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075523-001NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDEEQ 0.5MG BASE;EQ 50MG BASETABLET / ORALAB2000-03-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075523-001NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDEEQ 0.5MG BASE;EQ 50MG BASETABLET / ORALAB2000-03-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075523-001NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDEEQ 0.5MG BASE;EQ 50MG BASETABLET / ORALAB2000-03-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075523-001NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDEEQ 0.5MG BASE;EQ 50MG BASETABLET / ORALAB2000-03-17301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075523-001NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDEEQ 0.5MG BASE;EQ 50MG BASETABLET / ORALAB2000-03-171e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075523-001NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDEEQ 0.5MG BASE;EQ 50MG BASETABLET / ORALAB2000-03-178072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075523-001NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDEEQ 0.5MG BASE;EQ 50MG BASETABLET / ORALAB2000-03-175c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075523-001NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDEEQ 0.5MG BASE;EQ 50MG BASETABLET / ORALAB2000-03-175d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075523-001NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDEEQ 0.5MG BASE;EQ 50MG BASETABLET / ORALAB2000-03-174b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075523-001NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDEEQ 0.5MG BASE;EQ 50MG BASETABLET / ORALAB2000-03-1774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075523-001NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDEEQ 0.5MG BASE;EQ 50MG BASETABLET / ORALAB2000-03-17bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075523-001NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDEEQ 0.5MG BASE;EQ 50MG BASETABLET / ORALAB2000-03-17782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075523-001NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDEEQ 0.5MG BASE;EQ 50MG BASETABLET / ORALAB2000-03-1787673890dc5c…
2021-03-12 10:30 UTC2021-03A075523-001NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDEEQ 0.5MG BASE;EQ 50MG BASETABLET / ORALAB2000-03-175aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075523-001NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDEEQ 0.5MG BASE;EQ 50MG BASETABLET / ORALAB2000-03-178869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075523-001NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDEEQ 0.5MG BASE;EQ 50MG BASETABLET / ORALAB2000-03-17c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075523-001NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDEEQ 0.5MG BASE;EQ 50MG BASETABLET / ORALAB2000-03-173f01610625f2…
2019-09-15 20:21 UTC2019-09A075523-001NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDEEQ 0.5MG BASE;EQ 50MG BASETABLET / ORALAB2000-03-17b00525d2431f…
2019-07-19 19:46 UTC2019-07A075523-001NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDEEQ 0.5MG BASE;EQ 50MG BASETABLET / ORALAB2000-03-17ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A075523-001NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDEEQ 0.5MG BASE;EQ 50MG BASETABLET / ORALAB2000-03-176a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A075523-001NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDEEQ 0.5MG BASE;EQ 50MG BASETABLET / ORALAB2000-03-171c564ffb4f44…
2023-12-20 04:57 UTC2023-12A075523-001NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDEEQ 0.5MG BASE;EQ 50MG BASETABLET / ORALAB2000-03-17ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075523-001NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDEEQ 0.5MG BASE;EQ 50MG BASETABLET / ORALAB2000-03-17a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075523-001NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDEEQ 0.5MG BASE;EQ 50MG BASETABLET / ORALAB2000-03-179b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075523-001NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDEEQ 0.5MG BASE;EQ 50MG BASETABLET / ORALAB2000-03-17a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075523-001NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDEEQ 0.5MG BASE;EQ 50MG BASETABLET / ORALAB2000-03-173f0d92c62455…
2023-05-13 08:27 UTC2023-05A075523-001NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDEEQ 0.5MG BASE;EQ 50MG BASETABLET / ORALAB2000-03-17053a50430f4f…
2023-01-26 05:58 UTC2023-01A075523-001NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDEEQ 0.5MG BASE;EQ 50MG BASETABLET / ORALAB2000-03-173bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A075523-001NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDEEQ 0.5MG BASE;EQ 50MG BASETABLET / ORALAB2000-03-173a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A075523-001NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDEEQ 0.5MG BASE;EQ 50MG BASETABLET / ORALAB2000-03-17f41ea6bd6efb…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A075523-001AB184e616aacf4f…
2026-08-18 06:07:402026-07A075523-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075523-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075523-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075523-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075523-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075523-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075523-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075523-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075523-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075523-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075523-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075523-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075523-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075523-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075523-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075523-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075523-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075523-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075523-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075523-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075523-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075523-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A075523-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075523-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075523-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075523-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A075523-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A075523-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A075523-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A075523-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A075523-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075523-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075523-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075523-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075523-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A075523-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A075523-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A075523-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A075523-001AB1f41ea6bd6efb…

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
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PENTAZOCINE50 mg/1
NALOXONE HYDROCHLORIDE.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
RP4A60D26LInternal UNII lookup
F850569PQRInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
312289Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
41ebdaaf-3bbc-419f-b996-0341efc14623Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c955d208-c333-9bd7-be34-d7e12986d44eProduct name620250626
e5f98bfa-66d5-4c3a-b22d-9543d3bee304Product name120250204
caa6391e-3db3-c912-335f-61b5fc00aa12Product name920240110
65a3bc34-04ff-4cf1-aad9-c7d92a062f6dProduct name120231003
e951cdf3-f269-4d97-a7d5-c1c3d7283a7dProduct name320230313
ab841ac7-728a-4fc9-be0a-35b96cecbf39Product name420230306
f327b80c-8fa2-404b-838a-df3eec141cf2Product name120221212
d4aa2fcf-79c3-4b5f-a00e-1a8e26e00119Product name120220511
b871fccd-1de6-4c7f-b9e5-045304641ee6Product name820220118
43b1efe2-1425-4b3e-b3a2-57d40f8478b9Product name120211026
4c23a34c-e8fc-424c-8fa0-ee064ba6eaefProduct name120170706
0b8c7273-1da3-495f-909a-7cf1e96d2361Product name120161212
3df867ed-9d48-45cf-bded-1394beaea0b1Product name320161206
8a245632-e24f-4ccc-b671-995d89c96ebcProduct name120141203
35c9f831-b55b-8fa5-36b8-614b5af2a2abProduct name120140508
96c5169b-5b9d-547d-bf22-d688d91866e4Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63304-506-01pentazocine and naloxone100 in 1 BOTTLETABLET1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63304-506PENTAZOCINE AND NALOXONE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]2Current NDC, Legacy NDC, 1 package rows20180731_41ebdaaf-3bbc-419f-b996-0341efc14623.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
pentazocine and naloxonePENTAZOCINE AND NALOXONESun Pharmaceutical Industries, Inc.41ebdaaf-3bbc-419f-b996-0341efc146232018-07-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075523
application number: ANDA075523
ndc (product): 63304-506

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312289pentazocine 50 MG / naloxone 0.5 MG Oral TabletPSN41ebdaaf-3bbc-419f-b996-0341efc146232
312289naloxone 0.5 MG / pentazocine 50 MG Oral TabletSCD41ebdaaf-3bbc-419f-b996-0341efc146232
312289naloxone (as naloxone hydrochloride) 0.5 MG / pentazocine (as pentazocine hydrochloride) 50 MG Oral TabletSY41ebdaaf-3bbc-419f-b996-0341efc146232

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63304-506-0163304050601100 TABLET in 1 BOTTLE (63304-506-01) 100 tablet2018-07-310000-00-00NoNoCurrent