acetaminophen 250 mg and ibuprofen 125 mg

Generic: acetaminophen and ibuprofen

Labeler: dr. reddy's labortories inc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name acetaminophen 250 mg and ibuprofen 125 mg
Generic Name acetaminophen and ibuprofen
Labeler dr. reddy's labortories inc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

acetaminophen 250 mg/1, ibuprofen 125 mg/1

Manufacturer
Dr. Reddy's Labortories Inc

Identifiers & Regulatory

Product NDC 43598-052
Product ID 43598-052_49a54544-f18b-6461-9ed0-2740e8df4b6c
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA218247
Listing Expiration 2026-12-31
Marketing Start 2025-02-19

Pharmacologic Class

Established (EPC)
nonsteroidal anti-inflammatory drug [epc]
Mechanism of Action
cyclooxygenase inhibitors [moa]
Chemical Structure
anti-inflammatory agents, non-steroidal [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43598052
Hyphenated Format 43598-052

Supplemental Identifiers

RxCUI
2387532
UNII
362O9ITL9D WK2XYI10QM
NUI
N0000000160 M0001335 N0000175722

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name acetaminophen 250 mg and ibuprofen 125 mg (source: ndc)
Generic Name acetaminophen and ibuprofen (source: ndc)
Application Number ANDA218247 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/1
  • 125 mg/1
source: ndc
Packaging
  • 500 TABLET, FILM COATED in 1 BOTTLE (43598-052-05)
  • 144 TABLET, FILM COATED in 1 BOTTLE (43598-052-14)
  • 1 BOTTLE in 1 CARTON (43598-052-18) / 18 TABLET, FILM COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (43598-052-25) / 250 TABLET, FILM COATED in 1 BOTTLE
  • 250 TABLET, FILM COATED in 1 BOTTLE (43598-052-95)
source: ndc

Packages (5)

43598-052-05 500 TABLET, FILM COATED in 1 BOTTLE (43598-052-05) 43598-052-14 144 TABLET, FILM COATED in 1 BOTTLE (43598-052-14) 43598-052-18 1 BOTTLE in 1 CARTON (43598-052-18) / 18 TABLET, FILM COATED in 1 BOTTLE 43598-052-25 1 BOTTLE in 1 CARTON (43598-052-25) / 250 TABLET, FILM COATED in 1 BOTTLE 43598-052-95 250 TABLET, FILM COATED in 1 BOTTLE (43598-052-95)

Ingredients (2)

acetaminophen (250 mg/1) ibuprofen (125 mg/1)

Linked Drug Pages (1)

Acetaminophen 250 mg and Ibuprofen 125 mg ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "49a54544-f18b-6461-9ed0-2740e8df4b6c", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["362O9ITL9D", "WK2XYI10QM"], "rxcui": ["2387532"], "spl_set_id": ["3e65c8a3-498e-1a2a-bb76-18e28ae2c73c"], "pharm_class_cs": ["Anti-Inflammatory Agents, Non-Steroidal [CS]"], "pharm_class_epc": ["Nonsteroidal Anti-inflammatory Drug [EPC]"], "pharm_class_moa": ["Cyclooxygenase Inhibitors [MoA]"], "manufacturer_name": ["Dr. Reddy's Labortories Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (43598-052-05)", "package_ndc": "43598-052-05", "marketing_start_date": "20250219"}, {"sample": false, "description": "144 TABLET, FILM COATED in 1 BOTTLE (43598-052-14)", "package_ndc": "43598-052-14", "marketing_start_date": "20250219"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (43598-052-18)  / 18 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "43598-052-18", "marketing_start_date": "20250219"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (43598-052-25)  / 250 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "43598-052-25", "marketing_start_date": "20250219"}, {"sample": false, "description": "250 TABLET, FILM COATED in 1 BOTTLE (43598-052-95)", "package_ndc": "43598-052-95", "marketing_start_date": "20250219"}], "brand_name": "Acetaminophen 250 mg and Ibuprofen 125 mg", "product_id": "43598-052_49a54544-f18b-6461-9ed0-2740e8df4b6c", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "43598-052", "generic_name": "Acetaminophen and Ibuprofen", "labeler_name": "Dr. Reddy's Labortories Inc", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Acetaminophen 250 mg and Ibuprofen 125 mg", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "250 mg/1"}, {"name": "IBUPROFEN", "strength": "125 mg/1"}], "application_number": "ANDA218247", "marketing_category": "ANDA", "marketing_start_date": "20250219", "listing_expiration_date": "20261231"}