aacetaminophen and ibuprofen

Generic: acetaminophen and ibuprofen

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

Drug Facts

Product Profile

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

acetaminophen 250 mg/1, ibuprofen 125 mg/1

Manufacturer
GRANULES USA, INC.

Identifiers & Regulatory

Product NDC 69848-588
Product ID 69848-588_2a306431-7813-346e-e063-6294a90aca46
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA216592
Listing Expiration 2026-12-31
Marketing Start 2024-12-10

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 69848588
Hyphenated Format 69848-588

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 aacetaminophen 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
  • 72 TABLET in 1 BOTTLE (69848-588-72)
source: ndc

Packages (1)

69848-588-72 72 TABLET in 1 BOTTLE (69848-588-72)

Ingredients (2)

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

Linked Drug Pages (1)

Aacetaminophen and Ibuprofen ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2a306431-7813-346e-e063-6294a90aca46", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["362O9ITL9D", "WK2XYI10QM"], "rxcui": ["2387532"], "spl_set_id": ["1dd90684-6505-8e07-e063-6394a90afdf4"], "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 USA, INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "72 TABLET in 1 BOTTLE (69848-588-72)", "package_ndc": "69848-588-72", "marketing_start_date": "20241210"}], "brand_name": "Aacetaminophen and Ibuprofen", "product_id": "69848-588_2a306431-7813-346e-e063-6294a90aca46", "dosage_form": "TABLET", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "69848-588", "generic_name": "Acetaminophen and Ibuprofen", "labeler_name": "GRANULES USA, INC.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Aacetaminophen 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": "20241210", "listing_expiration_date": "20261231"}