Pentazocine HCl and Acetaminophen

Product NDC
21695-634
11-digit product format
216950634
Labeler code
21695
Product ID
21695-634_fbb6a064-59a6-4e1c-bbb6-5934c1505c4f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pentazocine Hydrochloride and Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Rebel Distributors Corp
Application
ANDA074699
Marketing category
ANDA
Marketing start
2000-03-24
Marketing end
0000-00-00
Substance
PENTAZOCINE HYDROCHLORIDE; ACETAMINOPHEN
Active strength
25 mg/1; mg/1
Pharmacologic classes
Competitive Opioid Antagonists [MoA],Partial Opioid Agonist/Antagonist [EPC],Partial Opioid Agonists [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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct21695-634IInactivated by FDA2026-10-12
excluded packagepackage21695-63421695-634-60IInactivated by FDA2026-10-12

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 dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage21695-634-60d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage21695-634-60f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage21695-634-602ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage21695-634-60a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage21695-634-60cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage21695-634-60cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage21695-634-60302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage21695-634-60ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage21695-634-600efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage21695-634-60ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage21695-634-60367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage21695-634-60557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage21695-634-608af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage21695-634-60834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage21695-634-601332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage21695-634-60fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage21695-634-6086f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage21695-634-60bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage21695-634-608dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage21695-634-60e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage21695-634-609bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage21695-634-60110d247fa046…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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A074699-001ACETAMINOPHEN AND PENTAZOCINE HYDROCHLORIDEACETAMINOPHEN; PENTAZOCINE HYDROCHLORIDE650MG;EQ 25MG BASETABLET / ORAL2000-03-24

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 22:38:342026-08A074699-001ACETAMINOPHEN AND PENTAZOCINE HYDROCHLORIDE650MG;EQ 25MG BASETABLET / ORAL2000-03-2484e616aacf4f…
2026-08-18 06:07:402026-07A074699-001ACETAMINOPHEN AND PENTAZOCINE HYDROCHLORIDE650MG;EQ 25MG BASETABLET / ORAL2000-03-24caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A074699-001ACETAMINOPHEN AND PENTAZOCINE HYDROCHLORIDE650MG;EQ 25MG BASETABLET / ORAL2000-03-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074699-001ACETAMINOPHEN AND PENTAZOCINE HYDROCHLORIDE650MG;EQ 25MG BASETABLET / ORAL2000-03-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08A074699-001ACETAMINOPHEN AND PENTAZOCINE HYDROCHLORIDE650MG;EQ 25MG BASETABLET / ORAL2000-03-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074699-001ACETAMINOPHEN AND PENTAZOCINE HYDROCHLORIDE650MG;EQ 25MG BASETABLET / ORAL2000-03-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074699-001ACETAMINOPHEN AND PENTAZOCINE HYDROCHLORIDE650MG;EQ 25MG BASETABLET / ORAL2000-03-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074699-001ACETAMINOPHEN AND PENTAZOCINE HYDROCHLORIDE650MG;EQ 25MG BASETABLET / ORAL2000-03-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074699-001ACETAMINOPHEN AND PENTAZOCINE HYDROCHLORIDE650MG;EQ 25MG BASETABLET / ORAL2000-03-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074699-001ACETAMINOPHEN AND PENTAZOCINE HYDROCHLORIDE650MG;EQ 25MG BASETABLET / ORAL2000-03-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074699-001ACETAMINOPHEN AND PENTAZOCINE HYDROCHLORIDE650MG;EQ 25MG BASETABLET / ORAL2000-03-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074699-001ACETAMINOPHEN AND PENTAZOCINE HYDROCHLORIDE650MG;EQ 25MG BASETABLET / ORAL2000-03-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074699-001ACETAMINOPHEN AND PENTAZOCINE HYDROCHLORIDE650MG;EQ 25MG BASETABLET / ORAL2000-03-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074699-001ACETAMINOPHEN AND PENTAZOCINE HYDROCHLORIDE650MG;EQ 25MG BASETABLET / ORAL2000-03-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074699-001ACETAMINOPHEN AND PENTAZOCINE HYDROCHLORIDE650MG;EQ 25MG BASETABLET / ORAL2000-03-241e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074699-001ACETAMINOPHEN AND PENTAZOCINE HYDROCHLORIDE650MG;EQ 25MG BASETABLET / ORAL2000-03-248072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074699-001ACETAMINOPHEN AND PENTAZOCINE HYDROCHLORIDE650MG;EQ 25MG BASETABLET / ORAL2000-03-245c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074699-001ACETAMINOPHEN AND PENTAZOCINE HYDROCHLORIDE650MG;EQ 25MG BASETABLET / ORAL2000-03-245d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074699-001ACETAMINOPHEN AND PENTAZOCINE HYDROCHLORIDE650MG;EQ 25MG BASETABLET / ORAL2000-03-244b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074699-001ACETAMINOPHEN AND PENTAZOCINE HYDROCHLORIDE650MG;EQ 25MG BASETABLET / ORAL2000-03-2474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074699-001ACETAMINOPHEN AND PENTAZOCINE HYDROCHLORIDE650MG;EQ 25MG BASETABLET / ORAL2000-03-24bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A074699-001ACETAMINOPHEN AND PENTAZOCINE HYDROCHLORIDE650MG;EQ 25MG BASETABLET / ORAL2000-03-24782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A074699-001ACETAMINOPHEN AND PENTAZOCINE HYDROCHLORIDE650MG;EQ 25MG BASETABLET / ORAL2000-03-2487673890dc5c…
2021-03-12 10:30 UTC2021-03A074699-001ACETAMINOPHEN AND PENTAZOCINE HYDROCHLORIDE650MG;EQ 25MG BASETABLET / ORAL2000-03-245aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A074699-001ACETAMINOPHEN AND PENTAZOCINE HYDROCHLORIDE650MG;EQ 25MG BASETABLET / ORAL2000-03-248869cabd3fbd…
2020-11-12 02:37 UTC2020-11A074699-001ACETAMINOPHEN AND PENTAZOCINE HYDROCHLORIDE650MG;EQ 25MG BASETABLET / ORAL2000-03-24c0c555d07b60…
2019-12-14 00:12 UTC2019-12A074699-001ACETAMINOPHEN AND PENTAZOCINE HYDROCHLORIDE650MG;EQ 25MG BASETABLET / ORAL2000-03-243f01610625f2…
2019-09-15 20:21 UTC2019-09A074699-001ACETAMINOPHEN AND PENTAZOCINE HYDROCHLORIDE650MG;EQ 25MG BASETABLET / ORAL2000-03-24b00525d2431f…
2019-07-19 19:46 UTC2019-07A074699-001ACETAMINOPHEN AND PENTAZOCINE HYDROCHLORIDE650MG;EQ 25MG BASETABLET / ORAL2000-03-24ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A074699-001ACETAMINOPHEN AND PENTAZOCINE HYDROCHLORIDE650MG;EQ 25MG BASETABLET / ORAL2000-03-246a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A074699-001ACETAMINOPHEN AND PENTAZOCINE HYDROCHLORIDE650MG;EQ 25MG BASETABLET / ORAL2000-03-241c564ffb4f44…
2023-12-20 04:57 UTC2023-12A074699-001ACETAMINOPHEN AND PENTAZOCINE HYDROCHLORIDE650MG;EQ 25MG BASETABLET / ORAL2000-03-24ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A074699-001ACETAMINOPHEN AND PENTAZOCINE HYDROCHLORIDE650MG;EQ 25MG BASETABLET / ORAL2000-03-24a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A074699-001ACETAMINOPHEN AND PENTAZOCINE HYDROCHLORIDE650MG;EQ 25MG BASETABLET / ORAL2000-03-249b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A074699-001ACETAMINOPHEN AND PENTAZOCINE HYDROCHLORIDE650MG;EQ 25MG BASETABLET / ORAL2000-03-24a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A074699-001ACETAMINOPHEN AND PENTAZOCINE HYDROCHLORIDE650MG;EQ 25MG BASETABLET / ORAL2000-03-243f0d92c62455…
2023-05-13 08:27 UTC2023-05A074699-001ACETAMINOPHEN AND PENTAZOCINE HYDROCHLORIDE650MG;EQ 25MG BASETABLET / ORAL2000-03-24053a50430f4f…
2023-01-26 05:58 UTC2023-01A074699-001ACETAMINOPHEN AND PENTAZOCINE HYDROCHLORIDE650MG;EQ 25MG BASETABLET / ORAL2000-03-243bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A074699-001ACETAMINOPHEN AND PENTAZOCINE HYDROCHLORIDE650MG;EQ 25MG BASETABLET / ORAL2000-03-243a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A074699-001ACETAMINOPHEN AND PENTAZOCINE HYDROCHLORIDE650MG;EQ 25MG BASETABLET / ORAL2000-03-24f41ea6bd6efb…

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 conceptRelationVersionEffective
35c9f831-b55b-8fa5-36b8-614b5af2a2abProduct name120140508
96c5169b-5b9d-547d-bf22-d688d91866e4Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21695-634-602019-09-24C16284748780-1934fe258-4c6b-48b1-e053-8cdaa90a720aPentazocine HCl and Acetaminophen Tablets C-IV Rx only 30276-4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-634-60Pentazocine HCl and Acetaminophen60 in 1 BOTTLETABLET601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-634-60EA - Each21695-6347244c49e-de8a-4284-b205-a6fc51b8dd9812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AcetaminophenACTIVE INGREDIENT362O9ITL9DPENTAZOCINE HCL AND ACETAMINOPHEN (PENTAZOCINE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [REBEL DISTRIBUTORS CORP]1
Pentazocine hydrochlorideACTIVE INGREDIENTA36BXO4PPXPENTAZOCINE HCL AND ACETAMINOPHEN (PENTAZOCINE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [REBEL DISTRIBUTORS CORP]1
AcetaminophenACTIVE MOIETY362O9ITL9DPENTAZOCINE HCL AND ACETAMINOPHEN (PENTAZOCINE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [REBEL DISTRIBUTORS CORP]1
PentazocineACTIVE MOIETYRP4A60D26LPENTAZOCINE HCL AND ACETAMINOPHEN (PENTAZOCINE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [REBEL DISTRIBUTORS CORP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPENTAZOCINE HCL AND ACETAMINOPHEN (PENTAZOCINE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [REBEL DISTRIBUTORS CORP]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKPENTAZOCINE HCL AND ACETAMINOPHEN (PENTAZOCINE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [REBEL DISTRIBUTORS CORP]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GPENTAZOCINE HCL AND ACETAMINOPHEN (PENTAZOCINE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [REBEL DISTRIBUTORS CORP]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPENTAZOCINE HCL AND ACETAMINOPHEN (PENTAZOCINE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [REBEL DISTRIBUTORS CORP]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EPENTAZOCINE HCL AND ACETAMINOPHEN (PENTAZOCINE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [REBEL DISTRIBUTORS CORP]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PENTAZOCINE HCL AND ACETAMINOPHEN (PENTAZOCINE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [REBEL DISTRIBUTORS CORP]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2PENTAZOCINE HCL AND ACETAMINOPHEN (PENTAZOCINE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [REBEL DISTRIBUTORS CORP]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPENTAZOCINE HCL AND ACETAMINOPHEN (PENTAZOCINE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [REBEL DISTRIBUTORS CORP]1
stearic acidINACTIVE INGREDIENT4ELV7Z65APPENTAZOCINE HCL AND ACETAMINOPHEN (PENTAZOCINE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-634PENTAZOCINE HCL AND ACETAMINOPHEN (PENTAZOCINE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [REBEL DISTRIBUTORS CORP]1Legacy NDC, 1 package rows20101201_fbb6a064-59a6-4e1c-bbb6-5934c1505c4f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312288pentazocine 25 MG / acetaminophen 650 MG Oral TabletPSNfbb6a064-59a6-4e1c-bbb6-5934c1505c4f1
312288acetaminophen 650 MG / pentazocine 25 MG Oral TabletSCDfbb6a064-59a6-4e1c-bbb6-5934c1505c4f1
312288APAP 650 MG / pentazocine (as pentazocine hydrochloride) 25 MG Oral TabletSYfbb6a064-59a6-4e1c-bbb6-5934c1505c4f1
312288APAP 650 MG / Pentazocine 25 MG Oral TabletSYfbb6a064-59a6-4e1c-bbb6-5934c1505c4f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-634-602169506346060 in 1 BOTTLEHistorical