ibuprofen and famotidine

Generic: ibuprofen and famotidine

Labeler: asclemed usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ibuprofen and famotidine
Generic Name ibuprofen and famotidine
Labeler asclemed usa, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

famotidine 26.6 mg/1, ibuprofen 800 mg/1

Manufacturer
Asclemed USA, Inc.

Identifiers & Regulatory

Product NDC 76420-891
Product ID 76420-891_2abbd7c9-640f-d0cb-e063-6294a90a23f0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211890
Listing Expiration 2026-12-31
Marketing Start 2021-08-04

Pharmacologic Class

Established (EPC)
histamine-2 receptor antagonist [epc] nonsteroidal anti-inflammatory drug [epc]
Mechanism of Action
histamine h2 receptor antagonists [moa] cyclooxygenase inhibitors [moa]
Chemical Structure
anti-inflammatory agents, non-steroidal [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 76420891
Hyphenated Format 76420-891

Supplemental Identifiers

RxCUI
1100066
UNII
5QZO15J2Z8 WK2XYI10QM
NUI
N0000000151 N0000175784 N0000000160 M0001335 N0000175722

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 ibuprofen and famotidine (source: ndc)
Generic Name ibuprofen and famotidine (source: ndc)
Application Number ANDA211890 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 26.6 mg/1
  • 800 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (76420-891-01)
  • 500 TABLET, FILM COATED in 1 BOTTLE (76420-891-05)
  • 6 BLISTER PACK in 1 CARTON (76420-891-06) / 1 TABLET, FILM COATED in 1 BLISTER PACK
  • 30 TABLET, FILM COATED in 1 BOTTLE (76420-891-30)
  • 60 TABLET, FILM COATED in 1 BOTTLE (76420-891-60)
  • 90 TABLET, FILM COATED in 1 BOTTLE (76420-891-90)
source: ndc

Packages (6)

76420-891-01 100 TABLET, FILM COATED in 1 BOTTLE (76420-891-01) 76420-891-05 500 TABLET, FILM COATED in 1 BOTTLE (76420-891-05) 76420-891-06 6 BLISTER PACK in 1 CARTON (76420-891-06) / 1 TABLET, FILM COATED in 1 BLISTER PACK 76420-891-30 30 TABLET, FILM COATED in 1 BOTTLE (76420-891-30) 76420-891-60 60 TABLET, FILM COATED in 1 BOTTLE (76420-891-60) 76420-891-90 90 TABLET, FILM COATED in 1 BOTTLE (76420-891-90)

Ingredients (2)

famotidine (26.6 mg/1) ibuprofen (800 mg/1)

Linked Drug Pages (1)

Ibuprofen and famotidine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2abbd7c9-640f-d0cb-e063-6294a90a23f0", "openfda": {"nui": ["N0000000151", "N0000175784", "N0000000160", "M0001335", "N0000175722"], "unii": ["5QZO15J2Z8", "WK2XYI10QM"], "rxcui": ["1100066"], "spl_set_id": ["41123df3-97ac-4c4f-9a89-f76ec03898bb"], "pharm_class_cs": ["Anti-Inflammatory Agents, Non-Steroidal [CS]"], "pharm_class_epc": ["Histamine-2 Receptor Antagonist [EPC]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "pharm_class_moa": ["Histamine H2 Receptor Antagonists [MoA]", "Cyclooxygenase Inhibitors [MoA]"], "manufacturer_name": ["Asclemed USA, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (76420-891-01)", "package_ndc": "76420-891-01", "marketing_start_date": "20250102"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (76420-891-05)", "package_ndc": "76420-891-05", "marketing_start_date": "20250102"}, {"sample": false, "description": "6 BLISTER PACK in 1 CARTON (76420-891-06)  / 1 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "76420-891-06", "marketing_start_date": "20250102"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (76420-891-30)", "package_ndc": "76420-891-30", "marketing_start_date": "20250102"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (76420-891-60)", "package_ndc": "76420-891-60", "marketing_start_date": "20250102"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (76420-891-90)", "package_ndc": "76420-891-90", "marketing_start_date": "20250102"}], "brand_name": "Ibuprofen and famotidine", "product_id": "76420-891_2abbd7c9-640f-d0cb-e063-6294a90a23f0", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Histamine H2 Receptor Antagonists [MoA]", "Histamine-2 Receptor Antagonist [EPC]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "76420-891", "generic_name": "Ibuprofen and famotidine", "labeler_name": "Asclemed USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ibuprofen and famotidine", "active_ingredients": [{"name": "FAMOTIDINE", "strength": "26.6 mg/1"}, {"name": "IBUPROFEN", "strength": "800 mg/1"}], "application_number": "ANDA211890", "marketing_category": "ANDA", "marketing_start_date": "20210804", "listing_expiration_date": "20261231"}