Home NDC 50844-598 Acetaminophen and Ibuprofen
Product NDC 50844-598
11-digit product format 508440598
Labeler code 50844
Product ID 50844-598_48c90e4c-f0be-4d69-9d89-a6ace79f51b0
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Ibuprofen
Dosage form TABLET, FILM COATED
Route ORAL
Labeler L.N.K. International, Inc.
Application ANDA220126
Marketing category ANDA
Marketing start 2026-09-10
Substance ACETAMINOPHEN; IBUPROFEN
Active strength 250; 125 mg/1; mg/1
Pharmacologic classes Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A220126-001 ACETAMINOPHEN AND IBUPROFEN ACETAMINOPHEN; IBUPROFEN 250MG;125MG TABLET / ORAL 2025-12-11
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A220126-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2025-12-11 84e616aacf4f…2026-08-18 06:07:40 2026-07 A220126-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2025-12-11 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A220126-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2025-12-11 011fe1cb6892…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A220126-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2025-12-11 a50c72e98297…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Acetaminophen and Ibuprofen
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 250 mg/1 IBUPROFEN 125 mg/1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 50844-598-14 50844059814 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50844-598-14) 2026-09-10 No No Current 50844-598-19 50844059819 1 BOTTLE, PLASTIC in 1 CARTON (50844-598-19) / 8 TABLET, FILM COATED in 1 BOTTLE, PLASTIC 2026-09-10 No No Current