acetaminophen and ibuprofen

Generic: acetaminophen and ibuprofen

Labeler: granules pharmaceuticals inc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name acetaminophen and ibuprofen
Generic Name acetaminophen and ibuprofen
Labeler granules pharmaceuticals inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

acetaminophen 250 mg/1, ibuprofen 125 mg/1

Manufacturer
Granules Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 70010-131
Product ID 70010-131_36a6254f-9451-951a-e063-6394a90a61d0
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA216592
Listing Expiration 2026-12-31
Marketing Start 2023-07-24

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 70010131
Hyphenated Format 70010-131

Supplemental Identifiers

RxCUI
2387532
UPC
0000000000000
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 and ibuprofen (source: ndc)
Generic Name acetaminophen and ibuprofen (source: ndc)
Application Number ANDA216592 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/1
  • 125 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (70010-131-26) / 18 TABLET in 1 BOTTLE
  • 288 TABLET in 1 BOTTLE (70010-131-31)
source: ndc

Packages (2)

70010-131-26 1 BOTTLE in 1 CARTON (70010-131-26) / 18 TABLET in 1 BOTTLE 70010-131-31 288 TABLET in 1 BOTTLE (70010-131-31)

Ingredients (2)

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

Linked Drug Pages (1)

Acetaminophen and Ibuprofen ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "36a6254f-9451-951a-e063-6394a90a61d0", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "upc": ["0000000000000"], "unii": ["362O9ITL9D", "WK2XYI10QM"], "rxcui": ["2387532"], "spl_set_id": ["0f8b9524-8fe3-47cf-bacd-93047442d90d"], "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": ["Granules Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (70010-131-26)  / 18 TABLET in 1 BOTTLE", "package_ndc": "70010-131-26", "marketing_start_date": "20230724"}, {"sample": false, "description": "288 TABLET in 1 BOTTLE (70010-131-31)", "package_ndc": "70010-131-31", "marketing_start_date": "20230724"}], "brand_name": "Acetaminophen and Ibuprofen", "product_id": "70010-131_36a6254f-9451-951a-e063-6394a90a61d0", "dosage_form": "TABLET", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "70010-131", "generic_name": "Acetaminophen and Ibuprofen", "labeler_name": "Granules Pharmaceuticals Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Acetaminophen and Ibuprofen", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "250 mg/1"}, {"name": "IBUPROFEN", "strength": "125 mg/1"}], "application_number": "ANDA216592", "marketing_category": "ANDA", "marketing_start_date": "20230724", "listing_expiration_date": "20261231"}