FDA.reportPublic FDA data

Hydrocodone Bitartrate and Acetaminophen

Product NDC
67296-1623
Requested package NDC
67296-1623-8
11-digit product format
672961623
Labeler code
67296
Product ID
67296-1623_b8d0796c-80c5-1386-e053-2a95a90a676f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrocodone Bitartrate and Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
ANDA209037
Marketing category
ANDA
Marketing start
2018-01-01
Marketing end
0000-00-00
Substance
HYDROCODONE BITARTRATE; ACETAMINOPHEN
Active strength
5 mg/1; mg/1
Pharmacologic classes
Opioid Agonist [EPC],Opioid Agonists [MoA]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage67296-162367296-1623-8IInactivated by FDA2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A209037-001HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATE325MG;5MGTABLET / ORALAA2017-06-21
A209037-002HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATE325MG;7.5MGTABLET / ORALAA2017-06-21
A209037-003HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATE325MG;10MGTABLET / ORALAA2017-06-21

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A209037-001AA
A209037-002AA
A209037-003AA

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A209037-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2017-06-21a50c72e98297…
2026-08-01 22:54:322026-06A209037-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2017-06-21a50c72e98297…
2026-08-01 22:54:322026-06A209037-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2017-06-21a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A209037-001AA1a50c72e98297…
2026-08-01 22:54:322026-06A209037-002AA1a50c72e98297…
2026-08-01 22:54:322026-06A209037-003AA1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENKVK-Tech, Inc.f1063950-b302-4898-81c2-b1626c9c16ef2026-02-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209037
application number: ANDA209037
HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENDirectRxcc0e654d-1eaa-7d17-e053-2995a90ab1db2025-01-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209037
application number: ANDA209037

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
06cc817f-60e0-4473-8e6b-c44d11dc5af6Product name920220921
53523715-c529-4d52-b9ff-1e5d76636f53Product name220210818
31b11e56-5b35-4ab6-a3a8-f0b48973dcedProduct name220200611
3a16d77a-e865-468a-aedf-6e58913c1c21Product name320190619
00d531e4-b130-8c52-eaf9-826cbb6f15ddProduct name320190205
aa0f353d-f35e-62e4-4e1f-5b563f01c659Product name920190205
22d922aa-c443-d9f3-b23c-03b03a9ad31cProduct name720181220
7855f8e3-562e-4273-8b79-0059c07a71f7Product name120170901
d17a97fa-387f-690e-d2be-0083ab044a03Product name320170725
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
a5244f9c-cd67-0e27-d63b-65fd7e584400Product name220170504
b654f2d9-ebeb-451d-96ee-22f583344623Product name120170424
557673c2-8256-b351-e863-4ec71a5a64b0Product name220160714
e974e22d-8688-7d92-1e87-40c1079e170cProduct name320151125
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
105ef617-6fa4-6713-326f-72ec8a6b75a9Product name120140508
53855190-7124-8179-f018-e792f7c27f28Product name120140508
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
84fb0b3d-1d72-b672-bc70-2b676a23e7e0Product name120140508
b8e0daf1-fb81-290b-c0bf-873be19ef775Product name120140508
d83c592c-dd97-4cbf-36ac-13da806684bdProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67296-1623-02026-01-29C16284748780-1f386c649-ec89-0266-e053-dadaa90a7c1ahydro apap 5/325
67296-1623-12026-01-29C16284748780-1f386c649-ec89-0266-e053-dadaa90a7c1ahydro apap 5/325
67296-1623-22026-01-29C16284748780-1f386c649-ec89-0266-e053-dadaa90a7c1ahydro apap 5/325
67296-1623-32026-01-29C16284748780-1f386c649-ec89-0266-e053-dadaa90a7c1ahydro apap 5/325
67296-1623-42026-01-29C16284748780-1f386c649-ec89-0266-e053-dadaa90a7c1ahydro apap 5/325
67296-1623-52026-01-29C16284748780-1f386c649-ec89-0266-e053-dadaa90a7c1ahydro apap 5/325
67296-1623-62026-01-29C16284748780-1f386c649-ec89-0266-e053-dadaa90a7c1ahydro apap 5/325
67296-1623-72026-01-29C16284748780-1f386c649-ec89-0266-e053-dadaa90a7c1ahydro apap 5/325
67296-1623-82026-01-29C16284748780-1f386c649-ec89-0266-e053-dadaa90a7c1ahydro apap 5/325
67296-1623-92026-01-29C16284748780-1f386c649-ec89-0266-e053-dadaa90a7c1ahydro apap 5/325
67296-1623-02024-07-24C16284748780-1f386c649-ec89-0266-e053-dadaa90a7c1ahydro apap 5/325
67296-1623-12024-07-24C16284748780-1f386c649-ec89-0266-e053-dadaa90a7c1ahydro apap 5/325
67296-1623-22024-07-24C16284748780-1f386c649-ec89-0266-e053-dadaa90a7c1ahydro apap 5/325
67296-1623-32024-07-24C16284748780-1f386c649-ec89-0266-e053-dadaa90a7c1ahydro apap 5/325
67296-1623-42024-07-24C16284748780-1f386c649-ec89-0266-e053-dadaa90a7c1ahydro apap 5/325
67296-1623-52024-07-24C16284748780-1f386c649-ec89-0266-e053-dadaa90a7c1ahydro apap 5/325
67296-1623-62024-07-24C16284748780-1f386c649-ec89-0266-e053-dadaa90a7c1ahydro apap 5/325
67296-1623-72024-07-24C16284748780-1f386c649-ec89-0266-e053-dadaa90a7c1ahydro apap 5/325
67296-1623-82024-07-24C16284748780-1f386c649-ec89-0266-e053-dadaa90a7c1ahydro apap 5/325
67296-1623-92024-07-24C16284748780-1f386c649-ec89-0266-e053-dadaa90a7c1ahydro apap 5/325
67296-1623-02023-01-30C16284748780-1f386c649-ec89-0266-e053-dadaa90a7c1ahydro apap 5/325
67296-1623-12023-01-30C16284748780-1f386c649-ec89-0266-e053-dadaa90a7c1ahydro apap 5/325
67296-1623-22023-01-30C16284748780-1f386c649-ec89-0266-e053-dadaa90a7c1ahydro apap 5/325
67296-1623-32023-01-30C16284748780-1f386c649-ec89-0266-e053-dadaa90a7c1ahydro apap 5/325
67296-1623-42023-01-30C16284748780-1f386c649-ec89-0266-e053-dadaa90a7c1ahydro apap 5/325
67296-1623-52023-01-30C16284748780-1f386c649-ec89-0266-e053-dadaa90a7c1ahydro apap 5/325
67296-1623-62023-01-30C16284748780-1f386c649-ec89-0266-e053-dadaa90a7c1ahydro apap 5/325
67296-1623-72023-01-30C16284748780-1f386c649-ec89-0266-e053-dadaa90a7c1ahydro apap 5/325
67296-1623-82023-01-30C16284748780-1f386c649-ec89-0266-e053-dadaa90a7c1ahydro apap 5/325
67296-1623-92023-01-30C16284748780-1f386c649-ec89-0266-e053-dadaa90a7c1ahydro apap 5/325

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-1623-0Hydrocodone Bitartrate and Acetaminophen40 in 1 BOTTLETABLET4014
67296-1623-1Hydrocodone Bitartrate and Acetaminophen10 in 1 BOTTLETABLET1014
67296-1623-2Hydrocodone Bitartrate and Acetaminophen20 in 1 BOTTLETABLET2014
67296-1623-3Hydrocodone Bitartrate and Acetaminophen30 in 1 BOTTLETABLET3014
67296-1623-4Hydrocodone Bitartrate and Acetaminophen4 in 1 BOTTLETABLET414
67296-1623-5Hydrocodone Bitartrate and Acetaminophen12 in 1 BOTTLETABLET1214
67296-1623-6Hydrocodone Bitartrate and Acetaminophen6 in 1 BOTTLETABLET614
67296-1623-7Hydrocodone Bitartrate and Acetaminophen15 in 1 BOTTLETABLET1514
67296-1623-8Hydrocodone Bitartrate and Acetaminophen50 in 1 BOTTLETABLET5014
67296-1623-9Hydrocodone Bitartrate and Acetaminophen60 in 1 BOTTLETABLET6014

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1623HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [REDPHARM DRUG, INC.]14Legacy NDC, 10 package rows20240725_7b24fc1d-6e2f-47f2-e053-2991aa0a01bb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857002HYDROcodone bitartrate 5 MG / acetaminophen 325 MG Oral TabletPSN7b24fc1d-6e2f-47f2-e053-2991aa0a01bb14
857002acetaminophen 325 MG / hydrocodone bitartrate 5 MG Oral TabletSCD7b24fc1d-6e2f-47f2-e053-2991aa0a01bb14
857002APAP 325 MG / hydrocodone bitartrate 5 MG Oral TabletSY7b24fc1d-6e2f-47f2-e053-2991aa0a01bb14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67296-1623-86729616230850 TABLET in 1 BOTTLE (67296-1623-8) 50 tablet2018-01-010000-00-00NoNoCurrent