FDA.reportPublic FDA data

oxycodone and acetaminophen

Product NDC
46672-193
11-digit product format
466720193
Labeler code
46672
Product ID
46672-193_abc1dd98-7e59-6815-e053-2995a90a01db
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
oxycodone and acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Mikart, LLC
Application
ANDA040608
Marketing category
ANDA
Marketing start
2005-12-30
Marketing end
0000-00-00
Substance
OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN
Active strength
3 mg/1; mg/1
Pharmacologic classes
Full Opioid Agonists [MoA],Opioid Agonist [EPC]
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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A040608-001OXYCODONE AND ACETAMINOPHENACETAMINOPHEN; OXYCODONE HYDROCHLORIDE300MG;2.5MGTABLET / ORALRS2005-12-30
A040608-002OXYCODONE AND ACETAMINOPHENACETAMINOPHEN; OXYCODONE HYDROCHLORIDE300MG;5MGTABLET / ORALRS2005-12-30
A040608-003OXYCODONE AND ACETAMINOPHENACETAMINOPHEN; OXYCODONE HYDROCHLORIDE300MG;7.5MGTABLET / ORALRS2005-12-30
A040608-004OXYCODONE AND ACETAMINOPHENACETAMINOPHEN; OXYCODONE HYDROCHLORIDE300MG;10MGTABLET / ORALRS2005-12-30

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 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A040608-001OXYCODONE AND ACETAMINOPHEN300MG;2.5MGTABLET / ORALRS2005-12-30caaa826d4ba7…
2026-08-18 06:07:402026-07A040608-002OXYCODONE AND ACETAMINOPHEN300MG;5MGTABLET / ORALRS2005-12-30caaa826d4ba7…
2026-08-18 06:07:402026-07A040608-003OXYCODONE AND ACETAMINOPHEN300MG;7.5MGTABLET / ORALRS2005-12-30caaa826d4ba7…
2026-08-18 06:07:402026-07A040608-004OXYCODONE AND ACETAMINOPHEN300MG;10MGTABLET / ORALRS2005-12-30caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040608-001OXYCODONE AND ACETAMINOPHEN300MG;2.5MGTABLET / ORALRS2005-12-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040608-002OXYCODONE AND ACETAMINOPHEN300MG;5MGTABLET / ORALRS2005-12-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040608-003OXYCODONE AND ACETAMINOPHEN300MG;7.5MGTABLET / ORALRS2005-12-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040608-004OXYCODONE AND ACETAMINOPHEN300MG;10MGTABLET / ORALRS2005-12-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040608-001OXYCODONE AND ACETAMINOPHEN300MG;2.5MGTABLET / ORALRS2005-12-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040608-002OXYCODONE AND ACETAMINOPHEN300MG;5MGTABLET / ORALRS2005-12-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040608-003OXYCODONE AND ACETAMINOPHEN300MG;7.5MGTABLET / ORALRS2005-12-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040608-004OXYCODONE AND ACETAMINOPHEN300MG;10MGTABLET / ORALRS2005-12-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A040608-001OXYCODONE AND ACETAMINOPHEN300MG;2.5MGTABLET / ORALRS2005-12-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040608-002OXYCODONE AND ACETAMINOPHEN300MG;5MGTABLET / ORALRS2005-12-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040608-003OXYCODONE AND ACETAMINOPHEN300MG;7.5MGTABLET / ORALRS2005-12-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040608-004OXYCODONE AND ACETAMINOPHEN300MG;10MGTABLET / ORALRS2005-12-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040608-001OXYCODONE AND ACETAMINOPHEN300MG;2.5MGTABLET / ORALRS2005-12-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040608-002OXYCODONE AND ACETAMINOPHEN300MG;5MGTABLET / ORALRS2005-12-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040608-003OXYCODONE AND ACETAMINOPHEN300MG;7.5MGTABLET / ORALRS2005-12-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040608-004OXYCODONE AND ACETAMINOPHEN300MG;10MGTABLET / ORALRS2005-12-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040608-001OXYCODONE AND ACETAMINOPHEN300MG;2.5MGTABLET / ORALRS2005-12-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040608-002OXYCODONE AND ACETAMINOPHEN300MG;5MGTABLET / ORALRS2005-12-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040608-003OXYCODONE AND ACETAMINOPHEN300MG;7.5MGTABLET / ORALRS2005-12-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040608-004OXYCODONE AND ACETAMINOPHEN300MG;10MGTABLET / ORALRS2005-12-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040608-001OXYCODONE AND ACETAMINOPHEN300MG;2.5MGTABLET / ORALRS2005-12-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040608-002OXYCODONE AND ACETAMINOPHEN300MG;5MGTABLET / ORALRS2005-12-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040608-003OXYCODONE AND ACETAMINOPHEN300MG;7.5MGTABLET / ORALRS2005-12-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040608-004OXYCODONE AND ACETAMINOPHEN300MG;10MGTABLET / ORALRS2005-12-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040608-001OXYCODONE AND ACETAMINOPHEN300MG;2.5MGTABLET / ORALRS2005-12-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040608-002OXYCODONE AND ACETAMINOPHEN300MG;5MGTABLET / ORALRS2005-12-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040608-003OXYCODONE AND ACETAMINOPHEN300MG;7.5MGTABLET / ORALRS2005-12-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040608-004OXYCODONE AND ACETAMINOPHEN300MG;10MGTABLET / ORALRS2005-12-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040608-001OXYCODONE AND ACETAMINOPHEN300MG;2.5MGTABLET / ORALRS2005-12-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040608-002OXYCODONE AND ACETAMINOPHEN300MG;5MGTABLET / ORALRS2005-12-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040608-003OXYCODONE AND ACETAMINOPHEN300MG;7.5MGTABLET / ORALRS2005-12-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040608-004OXYCODONE AND ACETAMINOPHEN300MG;10MGTABLET / ORALRS2005-12-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040608-001OXYCODONE AND ACETAMINOPHEN300MG;2.5MGTABLET / ORALRS2005-12-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040608-002OXYCODONE AND ACETAMINOPHEN300MG;5MGTABLET / ORALRS2005-12-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040608-003OXYCODONE AND ACETAMINOPHEN300MG;7.5MGTABLET / ORALRS2005-12-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040608-004OXYCODONE AND ACETAMINOPHEN300MG;10MGTABLET / ORALRS2005-12-30d8e5a09893c0…

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DOXYCODONE AND ACETAMINOPHEN TABLET [MIKART, INC.]1
OXYCODONE HYDROCHLORIDEACTIVE INGREDIENTC1ENJ2TE6COXYCODONE AND ACETAMINOPHEN TABLET [MIKART, INC.]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DOXYCODONE AND ACETAMINOPHEN TABLET [MIKART, INC.]1
OXYCODONEACTIVE MOIETYCD35PMG570OXYCODONE AND ACETAMINOPHEN TABLET [MIKART, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UOXYCODONE AND ACETAMINOPHEN TABLET [MIKART, INC.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48OXYCODONE AND ACETAMINOPHEN TABLET [MIKART, INC.]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKOXYCODONE AND ACETAMINOPHEN TABLET [MIKART, INC.]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GOXYCODONE AND ACETAMINOPHEN TABLET [MIKART, INC.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDOXYCODONE AND ACETAMINOPHEN TABLET [MIKART, INC.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAOXYCODONE AND ACETAMINOPHEN TABLET [MIKART, INC.]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8OXYCODONE AND ACETAMINOPHEN TABLET [MIKART, INC.]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EOXYCODONE AND ACETAMINOPHEN TABLET [MIKART, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4OXYCODONE AND ACETAMINOPHEN TABLET [MIKART, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJOXYCODONE AND ACETAMINOPHEN TABLET [MIKART, INC.]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APOXYCODONE AND ACETAMINOPHEN TABLET [MIKART, INC.]1

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NalocetOXYCODONE AND ACETAMINOPHENForte Bio-Pharma LLCf5f7dfca-a5c7-4445-8a5e-9ec62f33f5be2026-08-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040608
application number: ANDA040608
oxycodone and acetaminophenOXYCODONE AND ACETAMINOPHENFH2 Pharma LLC88d97caf-bcf5-3cde-e053-2995a90acf4a2026-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040608
application number: ANDA040608
ProlateOXYCODONE AND ACETAMINOPHENForte Bio-Pharma LLC9cbbfa94-37b9-9652-e053-2995a90a736b2026-05-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040608
application number: ANDA040608