FDA.reportPublic FDA data

Hydrocodone Bitartrate and Acetaminophen

Product NDC
53217-267
11-digit product format
532170267
Labeler code
53217
Product ID
53217-267_91bb8d23-6843-49f8-9c83-737cb591e4d3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrocodone Bitartrate and Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA201013
Marketing category
ANDA
Marketing start
2016-11-30
Marketing end
0000-00-00
Substance
HYDROCODONE BITARTRATE; ACETAMINOPHEN
Active strength
10 mg/1; mg/1
Pharmacologic classes
Opioid Agonist [EPC],Opioid Agonists [MoA]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2019-12-31
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 · 8 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct53217-267IInactivated by FDA2026-08-03
excluded packagepackage53217-26753217-267-12IInactivated by FDA2026-08-03
excluded packagepackage53217-26753217-267-15IInactivated by FDA2026-08-03
excluded packagepackage53217-26753217-267-20IInactivated by FDA2026-08-03
excluded packagepackage53217-26753217-267-24IInactivated by FDA2026-08-03
excluded packagepackage53217-26753217-267-30IInactivated by FDA2026-08-03
excluded packagepackage53217-26753217-267-60IInactivated by FDA2026-08-03
excluded packagepackage53217-26753217-267-90IInactivated by FDA2026-08-03

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
A201013-001HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATE325MG;5MGTABLET / ORALAA2012-04-11
A201013-002HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATE325MG;7.5MGTABLET / ORALAA2012-04-11
A201013-003HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATE325MG;10MGTABLET / ORALAA2012-04-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A201013-001AA
A201013-002AA
A201013-003AA

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 22:54:322026-06A201013-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2012-04-11a50c72e98297…
2026-08-01 22:54:322026-06A201013-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2012-04-11a50c72e98297…
2026-08-01 22:54:322026-06A201013-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2012-04-11a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A201013-001AA1a50c72e98297…
2026-08-01 22:54:322026-06A201013-002AA1a50c72e98297…
2026-08-01 22:54:322026-06A201013-003AA1a50c72e98297…

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 · 11 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepackddfe71cc-27bf-4807-b62f-e6cf982e2dfd2026-06-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201013
application number: ANDA201013
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepack88c031ee-3d3d-4e8a-b69b-d18db612a9f32026-01-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201013
application number: ANDA201013
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENAurolife Pharma, LLC60f43308-1deb-4f05-8f17-aa49ebdcf4982025-12-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201013
application number: ANDA201013
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepack59a92d79-5b2d-4c10-b0ac-ea766a0ff08b2024-10-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201013
application number: ANDA201013
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENNuCare Pharmaceuticals,Inc.8b132cf3-c138-59ae-e053-2995a90a98a22024-08-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201013
application number: ANDA201013
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENNuCare Pharmaceuticals,Inc.8c2a7a68-5a84-c909-e053-2995a90ad5b62024-06-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201013
application number: ANDA201013
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENNuCare Pharmaceuticals,Inc.8592e901-9353-6fb6-e053-2a91aa0ad33b2024-06-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201013
application number: ANDA201013
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENNuCare Pharmaceuticals,Inc.86be8920-2f35-fbc3-e053-2991aa0a00152024-06-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201013
application number: ANDA201013
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENProficient Rx LP82b24978-8b15-43a9-b5b0-3313ed2a73c22023-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201013
application number: ANDA201013
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENProficient Rx LPe6711f26-a01d-43e8-882a-d58561e4b67f2022-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201013
application number: ANDA201013
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENProficient Rx LP199d4915-cb3b-48f3-835d-a45d04a5c9402022-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201013
application number: ANDA201013

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
53217-267-122020-01-31C16284748780-19d75b9d0-daaa-f424-e053-dadaa90a57ceHydrocodone Bitartrate and Acetaminophen Tablets, USP
53217-267-152020-01-31C16284748780-19d75b9d0-daaa-f424-e053-dadaa90a57ceHydrocodone Bitartrate and Acetaminophen Tablets, USP
53217-267-202020-01-31C16284748780-19d75b9d0-daaa-f424-e053-dadaa90a57ceHydrocodone Bitartrate and Acetaminophen Tablets, USP
53217-267-242020-01-31C16284748780-19d75b9d0-daaa-f424-e053-dadaa90a57ceHydrocodone Bitartrate and Acetaminophen Tablets, USP
53217-267-302020-01-31C16284748780-19d75b9d0-daaa-f424-e053-dadaa90a57ceHydrocodone Bitartrate and Acetaminophen Tablets, USP
53217-267-602020-01-31C16284748780-19d75b9d0-daaa-f424-e053-dadaa90a57ceHydrocodone Bitartrate and Acetaminophen Tablets, USP
53217-267-902020-01-31C16284748780-19d75b9d0-daaa-f424-e053-dadaa90a57ceHydrocodone Bitartrate and Acetaminophen Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53217-267-12Hydrocodone Bitartrate and Acetaminophen12 in 1 BOTTLETABLET124
53217-267-15Hydrocodone Bitartrate and Acetaminophen15 in 1 BOTTLETABLET154
53217-267-20Hydrocodone Bitartrate and Acetaminophen20 in 1 BOTTLETABLET204
53217-267-24Hydrocodone Bitartrate and Acetaminophen24 in 1 BOTTLETABLET244
53217-267-30Hydrocodone Bitartrate and Acetaminophen30 in 1 BOTTLETABLET304
53217-267-60Hydrocodone Bitartrate and Acetaminophen60 in 1 BOTTLETABLET604
53217-267-90Hydrocodone Bitartrate and Acetaminophen90 in 1 BOTTLETABLET904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53217-267-12EA - Each53217-267ff5ccd8d-988c-4fcd-a8dc-95be4d842aca12017-05-03
53217-267-20EA - Each53217-267af94467d-ea92-41f8-a9cf-e67613575c4612017-05-03
53217-267-30EA - Each53217-26732f5d2a7-54e4-4477-a3fc-961df145e19912017-05-03
53217-267-60EA - Each53217-26795f9c3a1-61a5-4e34-9215-1aed02f3f3b612017-05-03
53217-267-90EA - Each53217-26711ba5c7c-3009-4eba-839d-2037e11ec9e412017-05-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53217-267HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [AIDAREX PHARMACEUTICALS LLC]4Legacy NDC, 7 package rows20170412_d8d44758-d9a9-45dc-854d-8c30a52fa955.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856999HYDROcodone bitartrate 10 MG / acetaminophen 325 MG Oral TabletPSNd8d44758-d9a9-45dc-854d-8c30a52fa9554
857002HYDROcodone bitartrate 5 MG / acetaminophen 325 MG Oral TabletPSNd8d44758-d9a9-45dc-854d-8c30a52fa9554
857005HYDROcodone bitartrate 7.5 MG / acetaminophen 325 MG Oral TabletPSNd8d44758-d9a9-45dc-854d-8c30a52fa9554
856999acetaminophen 325 MG / hydrocodone bitartrate 10 MG Oral TabletSCDd8d44758-d9a9-45dc-854d-8c30a52fa9554
857002acetaminophen 325 MG / hydrocodone bitartrate 5 MG Oral TabletSCDd8d44758-d9a9-45dc-854d-8c30a52fa9554
857005acetaminophen 325 MG / hydrocodone bitartrate 7.5 MG Oral TabletSCDd8d44758-d9a9-45dc-854d-8c30a52fa9554
856999APAP 325 MG / hydrocodone bitartrate 10 MG Oral TabletSYd8d44758-d9a9-45dc-854d-8c30a52fa9554
857002APAP 325 MG / hydrocodone bitartrate 5 MG Oral TabletSYd8d44758-d9a9-45dc-854d-8c30a52fa9554
857005APAP 325 MG / hydrocodone bitartrate 7.5 MG Oral TabletSYd8d44758-d9a9-45dc-854d-8c30a52fa9554

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53217-267-125321702671212 in 1 BOTTLEHistorical
53217-267-155321702671515 in 1 BOTTLEHistorical
53217-267-205321702672020 in 1 BOTTLEHistorical
53217-267-245321702672424 in 1 BOTTLEHistorical
53217-267-305321702673030 in 1 BOTTLEHistorical
53217-267-605321702676060 in 1 BOTTLEHistorical
53217-267-905321702679090 in 1 BOTTLEHistorical