ibuprofen

Generic: ibuprofen

Labeler: dolgencorp, inc. (dollar general & rexall)
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ibuprofen
Generic Name ibuprofen
Labeler dolgencorp, inc. (dollar general & rexall)
Dosage Form CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients

ibuprofen 200 mg/1

Manufacturer
Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)

Identifiers & Regulatory

Product NDC 55910-197
Product ID 55910-197_9bcf0bae-dc0d-454f-8d77-6a80a3c55bb0
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA078682
Listing Expiration 2026-12-31
Marketing Start 2021-04-30

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 55910197
Hyphenated Format 55910-197

Supplemental Identifiers

RxCUI
310964
UPC
0359726272803
UNII
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 ibuprofen (source: ndc)
Generic Name ibuprofen (source: ndc)
Application Number ANDA078682 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 BOX (55910-197-12) / 120 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC
  • 1 BOTTLE, PLASTIC in 1 BOX (55910-197-20) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC
  • 1 BOTTLE, PLASTIC in 1 BOX (55910-197-40) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC
  • 1 BOTTLE, PLASTIC in 1 BOX (55910-197-80) / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC
source: ndc

Packages (4)

55910-197-12 1 BOTTLE, PLASTIC in 1 BOX (55910-197-12) / 120 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC 55910-197-20 1 BOTTLE, PLASTIC in 1 BOX (55910-197-20) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC 55910-197-40 1 BOTTLE, PLASTIC in 1 BOX (55910-197-40) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC 55910-197-80 1 BOTTLE, PLASTIC in 1 BOX (55910-197-80) / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC

Ingredients (1)

ibuprofen (200 mg/1)

Linked Drug Pages (1)

Ibuprofen ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "9bcf0bae-dc0d-454f-8d77-6a80a3c55bb0", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "upc": ["0359726272803"], "unii": ["WK2XYI10QM"], "rxcui": ["310964"], "spl_set_id": ["7f510feb-023c-4974-af6d-3e7a30cef362"], "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": ["Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 BOX (55910-197-12)  / 120 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC", "package_ndc": "55910-197-12", "marketing_start_date": "20210430"}, {"sample": false, "description": "1 BOTTLE, PLASTIC in 1 BOX (55910-197-20)  / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC", "package_ndc": "55910-197-20", "marketing_start_date": "20210430"}, {"sample": false, "description": "1 BOTTLE, PLASTIC in 1 BOX (55910-197-40)  / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC", "package_ndc": "55910-197-40", "marketing_start_date": "20210430"}, {"sample": false, "description": "1 BOTTLE, PLASTIC in 1 BOX (55910-197-80)  / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC", "package_ndc": "55910-197-80", "marketing_start_date": "20210430"}], "brand_name": "Ibuprofen", "product_id": "55910-197_9bcf0bae-dc0d-454f-8d77-6a80a3c55bb0", "dosage_form": "CAPSULE, LIQUID FILLED", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "55910-197", "generic_name": "Ibuprofen", "labeler_name": "Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Ibuprofen", "active_ingredients": [{"name": "IBUPROFEN", "strength": "200 mg/1"}], "application_number": "ANDA078682", "marketing_category": "ANDA", "marketing_start_date": "20210430", "listing_expiration_date": "20261231"}