FDA.reportPublic FDA data

hydrocodone bitartrate and acetaminophen

Product NDC
46672-645
11-digit product format
466720645
Labeler code
46672
Product ID
46672-645_acc4d2a8-9bdb-fe2e-e053-2995a90a1d40
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
hydrocodone bitartrate and acetaminophen
Dosage form
SYRUP
Route
ORAL
Labeler
Mikart, LLC
Application
ANDA040881
Marketing category
ANDA
Marketing start
2010-02-25
Marketing end
0000-00-00
Substance
HYDROCODONE BITARTRATE; ACETAMINOPHEN
Active strength
10 mg/15mL; mg/15mL
Pharmacologic classes
Opioid Agonist [EPC],Opioid Agonists [MoA]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A040881-001HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATE300MG/15ML;10MG/15MLSOLUTION / ORALRS2010-02-25

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A040881-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG/15ML;10MG/15MLSOLUTION / ORALRS2010-02-25caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040881-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG/15ML;10MG/15MLSOLUTION / ORALRS2010-02-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040881-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG/15ML;10MG/15MLSOLUTION / ORALRS2010-02-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A040881-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG/15ML;10MG/15MLSOLUTION / ORALRS2010-02-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040881-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG/15ML;10MG/15MLSOLUTION / ORALRS2010-02-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040881-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG/15ML;10MG/15MLSOLUTION / ORALRS2010-02-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040881-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG/15ML;10MG/15MLSOLUTION / ORALRS2010-02-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040881-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG/15ML;10MG/15MLSOLUTION / ORALRS2010-02-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040881-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG/15ML;10MG/15MLSOLUTION / ORALRS2010-02-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040881-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG/15ML;10MG/15MLSOLUTION / ORALRS2010-02-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040881-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG/15ML;10MG/15MLSOLUTION / ORALRS2010-02-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040881-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG/15ML;10MG/15MLSOLUTION / ORALRS2010-02-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040881-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG/15ML;10MG/15MLSOLUTION / ORALRS2010-02-25301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040881-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG/15ML;10MG/15MLSOLUTION / ORALRS2010-02-251e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040881-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG/15ML;10MG/15MLSOLUTION / ORALRS2010-02-258072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040881-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG/15ML;10MG/15MLSOLUTION / ORALRS2010-02-255c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040881-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG/15ML;10MG/15MLSOLUTION / ORALAARS2010-02-255d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040881-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG/15ML;10MG/15MLSOLUTION / ORALAARS2010-02-254b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040881-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG/15ML;10MG/15MLSOLUTION / ORALRS2010-02-2574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040881-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG/15ML;10MG/15MLSOLUTION / ORALAARS2010-02-25bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040881-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG/15ML;10MG/15MLSOLUTION / ORALRS2010-02-25782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040881-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG/15ML;10MG/15MLSOLUTION / ORALRS2010-02-2587673890dc5c…
2021-03-12 10:30 UTC2021-03A040881-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG/15ML;10MG/15MLSOLUTION / ORALRS2010-02-255aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040881-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG/15ML;10MG/15MLSOLUTION / ORALRS2010-02-258869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040881-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG/15ML;10MG/15MLSOLUTION / ORALRS2010-02-25c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040881-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG/15ML;10MG/15MLSOLUTION / ORALRS2010-02-253f01610625f2…
2019-09-15 20:21 UTC2019-09A040881-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG/15ML;10MG/15MLSOLUTION / ORALRS2010-02-25b00525d2431f…
2019-07-19 19:46 UTC2019-07A040881-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG/15ML;10MG/15MLSOLUTION / ORALRS2010-02-25ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040881-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG/15ML;10MG/15MLSOLUTION / ORALRS2010-02-256a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040881-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG/15ML;10MG/15MLSOLUTION / ORALRS2010-02-251c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040881-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG/15ML;10MG/15MLSOLUTION / ORALRS2010-02-25ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040881-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG/15ML;10MG/15MLSOLUTION / ORALRS2010-02-25a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040881-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG/15ML;10MG/15MLSOLUTION / ORALRS2010-02-259b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040881-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG/15ML;10MG/15MLSOLUTION / ORALRS2010-02-25a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040881-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG/15ML;10MG/15MLSOLUTION / ORALRS2010-02-253f0d92c62455…
2023-05-13 08:27 UTC2023-05A040881-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG/15ML;10MG/15MLSOLUTION / ORALRS2010-02-25053a50430f4f…
2023-01-26 05:58 UTC2023-01A040881-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG/15ML;10MG/15MLSOLUTION / ORALRS2010-02-253bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040881-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG/15ML;10MG/15MLSOLUTION / ORALRS2010-02-253a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040881-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG/15ML;10MG/15MLSOLUTION / ORALRS2010-02-25f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040881-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG/15ML;10MG/15MLSOLUTION / ORALRS2010-02-25e64feba35796…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-04-08 23:34 UTC2022-04A040881-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040881-001AA14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A040881-001AA1bb7c543d1eb4…

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DHYDROCODONE BITARTRATE AND ACETAMINOPHEN SYRUP [MIKART, INC.]2
HYDROCODONE BITARTRATEACTIVE INGREDIENTNO70W886KKHYDROCODONE BITARTRATE AND ACETAMINOPHEN SYRUP [MIKART, INC.]2
ACETAMINOPHENACTIVE MOIETY362O9ITL9DHYDROCODONE BITARTRATE AND ACETAMINOPHEN SYRUP [MIKART, INC.]2
HYDROCODONEACTIVE MOIETY6YKS4Y3WQ7HYDROCODONE BITARTRATE AND ACETAMINOPHEN SYRUP [MIKART, INC.]2
ALCOHOLINACTIVE INGREDIENT3K9958V90MHYDROCODONE BITARTRATE AND ACETAMINOPHEN SYRUP [MIKART, INC.]2
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLHYDROCODONE BITARTRATE AND ACETAMINOPHEN SYRUP [MIKART, INC.]2
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LHYDROCODONE BITARTRATE AND ACETAMINOPHEN SYRUP [MIKART, INC.]2
ETHYL MALTOLINACTIVE INGREDIENTL6Q8K29L05HYDROCODONE BITARTRATE AND ACETAMINOPHEN SYRUP [MIKART, INC.]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAHYDROCODONE BITARTRATE AND ACETAMINOPHEN SYRUP [MIKART, INC.]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXHYDROCODONE BITARTRATE AND ACETAMINOPHEN SYRUP [MIKART, INC.]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9THYDROCODONE BITARTRATE AND ACETAMINOPHEN SYRUP [MIKART, INC.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3HYDROCODONE BITARTRATE AND ACETAMINOPHEN SYRUP [MIKART, INC.]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHHYDROCODONE BITARTRATE AND ACETAMINOPHEN SYRUP [MIKART, INC.]2
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYHYDROCODONE BITARTRATE AND ACETAMINOPHEN SYRUP [MIKART, INC.]2
SORBITOLINACTIVE INGREDIENT506T60A25RHYDROCODONE BITARTRATE AND ACETAMINOPHEN SYRUP [MIKART, INC.]2
SUCROSEINACTIVE INGREDIENTC151H8M554HYDROCODONE BITARTRATE AND ACETAMINOPHEN SYRUP [MIKART, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RHYDROCODONE BITARTRATE AND ACETAMINOPHEN SYRUP [MIKART, INC.]2

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 1 · 1 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-b3b4-8c5752438fb72026-04-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040881
application number: ANDA040881