ibuprofen and famotidine

Generic: ibuprofen and famotidine

Labeler: ascend laboratories, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ibuprofen and famotidine
Generic Name ibuprofen and famotidine
Labeler ascend laboratories, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

famotidine 26.6 mg/1, ibuprofen 800 mg/1

Manufacturer
Ascend Laboratories, LLC

Identifiers & Regulatory

Product NDC 67877-626
Product ID 67877-626_5107e958-bc99-4832-931e-4c47e25ec6eb
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 67877626
Hyphenated Format 67877-626

Supplemental Identifiers

RxCUI
1100066
UPC
0367877626901 0367877626062
UNII
5QZO15J2Z8 WK2XYI10QM
NUI
N0000000151 N0000175784 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 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 (67877-626-01)
  • 500 TABLET, FILM COATED in 1 BOTTLE (67877-626-05)
  • 6 BLISTER PACK in 1 CARTON (67877-626-06) / 1 TABLET, FILM COATED in 1 BLISTER PACK
  • 90 TABLET, FILM COATED in 1 BOTTLE (67877-626-90)
source: ndc

Packages (4)

67877-626-01 100 TABLET, FILM COATED in 1 BOTTLE (67877-626-01) 67877-626-05 500 TABLET, FILM COATED in 1 BOTTLE (67877-626-05) 67877-626-06 6 BLISTER PACK in 1 CARTON (67877-626-06) / 1 TABLET, FILM COATED in 1 BLISTER PACK 67877-626-90 90 TABLET, FILM COATED in 1 BOTTLE (67877-626-90)

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": "5107e958-bc99-4832-931e-4c47e25ec6eb", "openfda": {"nui": ["N0000000151", "N0000175784", "N0000000160", "M0001335", "N0000175722"], "upc": ["0367877626901", "0367877626062"], "unii": ["5QZO15J2Z8", "WK2XYI10QM"], "rxcui": ["1100066"], "spl_set_id": ["4493d4cd-ca8e-4b0a-9b65-b75e55bf8b9e"], "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": ["Ascend Laboratories, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (67877-626-01)", "package_ndc": "67877-626-01", "marketing_start_date": "20210804"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (67877-626-05)", "package_ndc": "67877-626-05", "marketing_start_date": "20210804"}, {"sample": false, "description": "6 BLISTER PACK in 1 CARTON (67877-626-06)  / 1 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "67877-626-06", "marketing_start_date": "20210804"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (67877-626-90)", "package_ndc": "67877-626-90", "marketing_start_date": "20210804"}], "brand_name": "Ibuprofen and famotidine", "product_id": "67877-626_5107e958-bc99-4832-931e-4c47e25ec6eb", "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": "67877-626", "generic_name": "Ibuprofen and famotidine", "labeler_name": "Ascend Laboratories, LLC", "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"}