Home NDC 43598-052 Acetaminophen 250 mg and Ibuprofen 125 mg
Product NDC 43598-052
11-digit product format 435980052
Labeler code 43598
Product ID 43598-052_49a54544-f18b-6461-9ed0-2740e8df4b6c
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen and Ibuprofen
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Dr. Reddy's Labortories Inc
Application ANDA218247
Marketing category ANDA
Marketing start 2025-02-19
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 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A218247-001 ACETAMINOPHEN AND IBUPROFEN ACETAMINOPHEN; IBUPROFEN 250MG;125MG TABLET / ORAL 2024-08-23
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 2026-02-19 14:30 UTC 2026-02 A218247-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2024-08-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218247-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2024-08-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A218247-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2024-08-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218247-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2024-08-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218247-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2024-08-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A218247-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2024-08-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A218247-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2024-08-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A218247-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2024-08-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A218247-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2024-08-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A218247-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2024-08-23 d06236e962d9…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218247-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2024-08-23 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base Acetaminophen 250 mg and Ibuprofen 125 mg
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength IBUPROFEN 250 mg/1 ACETAMINOPHEN 125 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination WK2XYI10QM Internal UNII lookup 362O9ITL9D Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2387532 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 43598-052-05 Acetaminophen 250 mg and Ibuprofen 125 mg 500 in 1 BOTTLE TABLET, FILM COATED 500 6 43598-052-14 Acetaminophen 250 mg and Ibuprofen 125 mg 144 in 1 BOTTLE TABLET, FILM COATED 144 6 43598-052-18 Acetaminophen 250 mg and Ibuprofen 125 mg 18 in 1 BOTTLE TABLET, FILM COATED 18 6 43598-052-18 Acetaminophen 250 mg and Ibuprofen 125 mg 1 in 1 CARTON TABLET, FILM COATED 1 6 43598-052-25 Acetaminophen 250 mg and Ibuprofen 125 mg 250 in 1 BOTTLE TABLET, FILM COATED 250 6 43598-052-25 Acetaminophen 250 mg and Ibuprofen 125 mg 1 in 1 CARTON TABLET, FILM COATED 1 6 43598-052-95 Acetaminophen 250 mg and Ibuprofen 125 mg 250 in 1 BOTTLE TABLET, FILM COATED 250 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43598-052 ACETAMINOPHEN 250 MG AND IBUPROFEN 125 MG (ACETAMINOPHEN AND IBUPROFEN) TABLET, FILM COATED [DR. REDDY'S LABORTORIES INC] 4 Current NDC, 7 package rows 20250209_3e65c8a3-498e-1a2a-bb76-18e28ae2c73c.zip
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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 43598-052-05 43598005205 500 TABLET, FILM COATED in 1 BOTTLE (43598-052-05) 2025-02-19 No No Current 43598-052-14 43598005214 144 TABLET, FILM COATED in 1 BOTTLE (43598-052-14) 2025-02-19 No No Current 43598-052-18 43598005218 1 BOTTLE in 1 CARTON (43598-052-18) / 18 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2025-02-19 No No Current 43598-052-25 43598005225 1 BOTTLE in 1 CARTON (43598-052-25) / 250 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2025-02-19 No No Current 43598-052-95 43598005295 250 TABLET, FILM COATED in 1 BOTTLE (43598-052-95) 2025-02-19 No No Current