FDA.reportPublic FDA data

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product NDC
52959-324
11-digit product format
529590324
Labeler code
52959
Product ID
52959-324_76b7cd4b-14ea-7025-e053-2991aa0a16fd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Dosage form
TABLET
Route
ORAL
Labeler
H.J. Harkins Company, Inc.
Application
ANDA201013
Marketing category
ANDA
Marketing start
2015-12-29
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 · 15 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct52959-324IInactivated by FDA2026-07-31
excluded packagepackage52959-32452959-324-00IInactivated by FDA2026-07-31
excluded packagepackage52959-32452959-324-02IInactivated by FDA2026-07-31
excluded packagepackage52959-32452959-324-04IInactivated by FDA2026-07-31
excluded packagepackage52959-32452959-324-10IInactivated by FDA2026-07-31
excluded packagepackage52959-32452959-324-12IInactivated by FDA2026-07-31
excluded packagepackage52959-32452959-324-15IInactivated by FDA2026-07-31
excluded packagepackage52959-32452959-324-20IInactivated by FDA2026-07-31
excluded packagepackage52959-32452959-324-24IInactivated by FDA2026-07-31
excluded packagepackage52959-32452959-324-28IInactivated by FDA2026-07-31
excluded packagepackage52959-32452959-324-30IInactivated by FDA2026-07-31
excluded packagepackage52959-32452959-324-40IInactivated by FDA2026-07-31
excluded packagepackage52959-32452959-324-60IInactivated by FDA2026-07-31
excluded packagepackage52959-32452959-324-75IInactivated by FDA2026-07-31
excluded packagepackage52959-32452959-324-90IInactivated 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
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
52959-324-002020-01-31C16284748780-19d75b9d0-9061-f424-e053-dadaa90a57ce0324 HYDRO/APAP 10/325MG
52959-324-022020-01-31C16284748780-19d75b9d0-9061-f424-e053-dadaa90a57ce0324 HYDRO/APAP 10/325MG
52959-324-042020-01-31C16284748780-19d75b9d0-9061-f424-e053-dadaa90a57ce0324 HYDRO/APAP 10/325MG
52959-324-102020-01-31C16284748780-19d75b9d0-9061-f424-e053-dadaa90a57ce0324 HYDRO/APAP 10/325MG
52959-324-122020-01-31C16284748780-19d75b9d0-9061-f424-e053-dadaa90a57ce0324 HYDRO/APAP 10/325MG
52959-324-152020-01-31C16284748780-19d75b9d0-9061-f424-e053-dadaa90a57ce0324 HYDRO/APAP 10/325MG
52959-324-202020-01-31C16284748780-19d75b9d0-9061-f424-e053-dadaa90a57ce0324 HYDRO/APAP 10/325MG
52959-324-242020-01-31C16284748780-19d75b9d0-9061-f424-e053-dadaa90a57ce0324 HYDRO/APAP 10/325MG
52959-324-282020-01-31C16284748780-19d75b9d0-9061-f424-e053-dadaa90a57ce0324 HYDRO/APAP 10/325MG
52959-324-302020-01-31C16284748780-19d75b9d0-9061-f424-e053-dadaa90a57ce0324 HYDRO/APAP 10/325MG
52959-324-402020-01-31C16284748780-19d75b9d0-9061-f424-e053-dadaa90a57ce0324 HYDRO/APAP 10/325MG
52959-324-602020-01-31C16284748780-19d75b9d0-9061-f424-e053-dadaa90a57ce0324 HYDRO/APAP 10/325MG
52959-324-752020-01-31C16284748780-19d75b9d0-9061-f424-e053-dadaa90a57ce0324 HYDRO/APAP 10/325MG
52959-324-902020-01-31C16284748780-19d75b9d0-9061-f424-e053-dadaa90a57ce0324 HYDRO/APAP 10/325MG

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-324-60Theracodophen-32560 in 1 BOTTLETABLET60325 mg14
52959-324-00HYDROCODONE BITARTRATE AND ACETAMINOPHEN100 in 1 BOTTLETABLET1001
52959-324-02HYDROCODONE BITARTRATE AND ACETAMINOPHEN120 in 1 BOTTLETABLET1201
52959-324-04HYDROCODONE BITARTRATE AND ACETAMINOPHEN4 in 1 BOTTLETABLET41
52959-324-10HYDROCODONE BITARTRATE AND ACETAMINOPHEN10 in 1 BOTTLETABLET101
52959-324-12HYDROCODONE BITARTRATE AND ACETAMINOPHEN12 in 1 BOTTLETABLET121
52959-324-15HYDROCODONE BITARTRATE AND ACETAMINOPHEN15 in 1 BOTTLETABLET151
52959-324-20HYDROCODONE BITARTRATE AND ACETAMINOPHEN20 in 1 BOTTLETABLET201
52959-324-24HYDROCODONE BITARTRATE AND ACETAMINOPHEN24 in 1 BOTTLETABLET241
52959-324-28HYDROCODONE BITARTRATE AND ACETAMINOPHEN28 in 1 BOTTLETABLET281
52959-324-30HYDROCODONE BITARTRATE AND ACETAMINOPHEN30 in 1 BOTTLETABLET301
52959-324-40HYDROCODONE BITARTRATE AND ACETAMINOPHEN40 in 1 BOTTLETABLET401
52959-324-60HYDROCODONE BITARTRATE AND ACETAMINOPHEN60 in 1 BOTTLETABLET601
52959-324-75HYDROCODONE BITARTRATE AND ACETAMINOPHEN75 in 1 BOTTLETABLET751
52959-324-90HYDROCODONE BITARTRATE AND ACETAMINOPHEN90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52959-324-00EA - Each52959-32410381773-4eec-40c7-94c6-2c76adc0093912018-10-11
52959-324-02EA - Each52959-324a95b6652-4c34-410c-b5c2-58a52dbec11012018-10-11
52959-324-10EA - Each52959-324e7bcdb7d-1e96-4dad-a3f4-afd88c8759ec12018-10-11
52959-324-15EA - Each52959-32423f11780-be7c-401f-a895-4f846fae3a2d12018-10-11
52959-324-20EA - Each52959-3245803c0a3-4320-435f-883f-2eb1f1237f9412018-10-11
52959-324-24EA - Each52959-324b050f345-150a-4c6a-8b57-607e8b4a90fb12018-10-11
52959-324-28EA - Each52959-324797052be-411a-4c89-8450-f7ee397a2d5d12018-10-11
52959-324-30EA - Each52959-324865103bf-bc4e-40a7-b284-7df91f230cb112018-10-11
52959-324-40EA - Each52959-3246b6d88a2-d23d-4614-93a8-3168bf909f4112018-10-11
52959-324-60EA - Each52959-324292cb213-dbba-4d60-9eae-6198f192089d12018-10-11
52959-324-75EA - Each52959-324fda0255c-e83b-4640-a044-10f8d2e8f4eb12018-10-11
52959-324-90EA - Each52959-324b8e06d03-31f2-4dfd-bdc5-5a705d1a798212018-10-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
.GAMMA.-AMINOBUTYRIC ACIDACTIVE INGREDIENT2ACZ6IPC6ITHERACODOPHEN-325 (HYDROCODONE BITARTRATE, ACETAMINOPHEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]14
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DTHERACODOPHEN-325 (HYDROCODONE BITARTRATE, ACETAMINOPHEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]14
HYDROCODONE BITARTRATEACTIVE INGREDIENTNO70W886KKTHERACODOPHEN-325 (HYDROCODONE BITARTRATE, ACETAMINOPHEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]14
.GAMMA.-AMINOBUTYRIC ACIDACTIVE MOIETY2ACZ6IPC6ITHERACODOPHEN-325 (HYDROCODONE BITARTRATE, ACETAMINOPHEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]14
ACETAMINOPHENACTIVE MOIETY362O9ITL9DTHERACODOPHEN-325 (HYDROCODONE BITARTRATE, ACETAMINOPHEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]14
HYDROCODONEACTIVE MOIETY6YKS4Y3WQ7THERACODOPHEN-325 (HYDROCODONE BITARTRATE, ACETAMINOPHEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]14
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTHERACODOPHEN-325 (HYDROCODONE BITARTRATE, ACETAMINOPHEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]14
GELATININACTIVE INGREDIENT2G86QN327LTHERACODOPHEN-325 (HYDROCODONE BITARTRATE, ACETAMINOPHEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]14
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30THERACODOPHEN-325 (HYDROCODONE BITARTRATE, ACETAMINOPHEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]14
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DTHERACODOPHEN-325 (HYDROCODONE BITARTRATE, ACETAMINOPHEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]14
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4THERACODOPHEN-325 (HYDROCODONE BITARTRATE, ACETAMINOPHEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-324THERACODOPHEN-325 (HYDROCODONE BITARTRATE, ACETAMINOPHEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]14Legacy NDC20110815_8965ee35-89b9-4c11-9cee-fdcbe886cf6e.zip
52959-324HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [H.J. HARKINS COMPANY, INC.]1Legacy NDC, 14 package rows20180928_76b7cd4b-14e9-7025-e053-2991aa0a16fd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856999HYDROcodone bitartrate 10 MG / acetaminophen 325 MG Oral TabletPSN8965ee35-89b9-4c11-9cee-fdcbe886cf6e14
856999acetaminophen 325 MG / hydrocodone bitartrate 10 MG Oral TabletSCD8965ee35-89b9-4c11-9cee-fdcbe886cf6e14
856999APAP 325 MG / hydrocodone bitartrate 10 MG Oral TabletSY8965ee35-89b9-4c11-9cee-fdcbe886cf6e14
856999HYDROcodone bitartrate 10 MG / acetaminophen 325 MG Oral TabletPSN76b7cd4b-14e9-7025-e053-2991aa0a16fd1
856999acetaminophen 325 MG / hydrocodone bitartrate 10 MG Oral TabletSCD76b7cd4b-14e9-7025-e053-2991aa0a16fd1
856999APAP 325 MG / hydrocodone bitartrate 10 MG Oral TabletSY76b7cd4b-14e9-7025-e053-2991aa0a16fd1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
52959-324-0052959032400100 in 1 BOTTLEHistorical
52959-324-0252959032402120 in 1 BOTTLEHistorical
52959-324-04529590324044 in 1 BOTTLEHistorical
52959-324-105295903241010 in 1 BOTTLEHistorical
52959-324-125295903241212 in 1 BOTTLEHistorical
52959-324-155295903241515 in 1 BOTTLEHistorical
52959-324-205295903242020 in 1 BOTTLEHistorical
52959-324-245295903242424 in 1 BOTTLEHistorical
52959-324-285295903242828 in 1 BOTTLEHistorical
52959-324-305295903243030 in 1 BOTTLEHistorical
52959-324-405295903244040 in 1 BOTTLEHistorical
52959-324-605295903246060 in 1 BOTTLEHistorical
52959-324-755295903247575 in 1 BOTTLEHistorical
52959-324-905295903249090 in 1 BOTTLEHistorical