FDA.reportPublic FDA data

Application 081069

Type
ANDA
Sponsor
MIKART

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATECAPSULE;ORAL500MG;5MGNoNo

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
A081069-001HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATE500MG;5MGCAPSULE / ORAL1989-11-30

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 2 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-09-29 23:25 UTC2022-09A081069-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN500MG;5MGCAPSULE / ORAL1989-11-30e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A081069-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN500MG;5MGCAPSULE / ORAL1989-11-30cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A081069-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN500MG;5MGCAPSULE / ORAL1989-11-30a50c72e98297…

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 8 · 146 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENHikma Pharmaceuticals USA Inc.995a6cc7-8b72-4d35-b3b4-8c5752438fb72026-07-28Boxed warning, Warnings, Adverse reactionsName fallback
brand name: HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENEywa Pharma Incadb37532-aa19-48a2-95a1-8c92a6ce86512026-07-18Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Hydrocodone Bitartrate and Acetaminophen
hydrocodone bitartrate and acetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENProficient Rx LPd36f86e2-fe0f-4b74-a5bf-b23082d72da22026-07-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: hydrocodone bitartrate and acetaminophen
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepack8ad0df84-e3f6-4c1d-b791-c8467eb984aa2026-06-18Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Hydrocodone Bitartrate and Acetaminophen
HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENSt. Mary's Medical Park Pharmacy3d3292f0-93b5-1fd0-e063-6294a90a37162026-06-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepackddfe71cc-27bf-4807-b62f-e6cf982e2dfd2026-06-11Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Hydrocodone Bitartrate and Acetaminophen
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENSt. Mary's Medical Park Pharmacy425258b6-72d7-e9b5-e063-6394a90a3fc72026-06-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Hydrocodone Bitartrate and Acetaminophen
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENSt. Mary's Medical Park Pharmacy4135fb50-2e77-7365-e063-6294a90a8c432026-06-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Hydrocodone Bitartrate and Acetaminophen
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepack418ea599-55e0-4d57-a4b1-16568e30f6f72026-06-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Hydrocodone Bitartrate and Acetaminophen
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepack25d49886-9f9a-4015-bca2-9190b30d91202026-06-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Hydrocodone Bitartrate and Acetaminophen
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepacke83d90f9-513b-47c2-ae2a-748ce775ef5d2026-06-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Hydrocodone Bitartrate and Acetaminophen
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepack380ff458-d5d7-422e-ac96-e9a56ade16b62026-06-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Hydrocodone Bitartrate and Acetaminophen
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENRhodes Pharmaceuticals LLC1f9c1adc-f84f-43de-af5c-d93703aba7f82026-05-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Hydrocodone Bitartrate and Acetaminophen
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepack65c5abc7-520a-4267-acb6-ea6204a3ecfa2026-05-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Hydrocodone Bitartrate and Acetaminophen
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepack44687e20-a1c4-4cf3-b2ac-4d489d54b7402026-05-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Hydrocodone Bitartrate and Acetaminophen
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepack3d431951-eb0f-45ac-a6ba-d99929bdcaaf2026-05-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Hydrocodone Bitartrate and Acetaminophen
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepack878c004c-1e92-4400-95f5-e79cf9ba68442026-05-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Hydrocodone Bitartrate and Acetaminophen
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepack080d8fbd-a2c5-45b1-a9cf-2b6dd42ec4c72026-05-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Hydrocodone Bitartrate and Acetaminophen
HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENST. MARY'S MEDICAL PARK PHARMACY3d342071-7fdd-d899-e063-6294a90ae7822026-05-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepack375c3f81-3276-431e-8773-7b189730e9fd2026-05-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Hydrocodone Bitartrate and Acetaminophen

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.