dye-free ibuprofen

Generic: ibuprofen

Labeler: chain drug marketing association inc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dye-free ibuprofen
Generic Name ibuprofen
Labeler chain drug marketing association inc.
Dosage Form CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients

ibuprofen 200 mg/1201

Manufacturer
CHAIN DRUG MARKETING ASSOCIATION INC.

Identifiers & Regulatory

Product NDC 63868-805
Product ID 63868-805_f0d274bd-b6b5-74c9-e053-2995a90a6f72
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA078682
Listing Expiration 2026-12-31
Marketing Start 2021-11-16

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 63868805
Hyphenated Format 63868-805

Supplemental Identifiers

RxCUI
310964
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 dye-free ibuprofen (source: ndc)
Generic Name ibuprofen (source: ndc)
Application Number ANDA078682 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1201
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (63868-805-40) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE
source: ndc

Packages (1)

63868-805-40 1 BOTTLE in 1 CARTON (63868-805-40) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE

Ingredients (1)

ibuprofen (200 mg/1201)

Linked Drug Pages (1)

Dye-Free Ibuprofen ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "f0d274bd-b6b5-74c9-e053-2995a90a6f72", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["WK2XYI10QM"], "rxcui": ["310964"], "spl_set_id": ["d0eff659-6445-a56a-e053-2995a90a72e9"], "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": ["CHAIN DRUG MARKETING ASSOCIATION INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (63868-805-40)  / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE", "package_ndc": "63868-805-40", "marketing_start_date": "20211116"}], "brand_name": "Dye-Free Ibuprofen", "product_id": "63868-805_f0d274bd-b6b5-74c9-e053-2995a90a6f72", "dosage_form": "CAPSULE, LIQUID FILLED", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "63868-805", "generic_name": "Ibuprofen", "labeler_name": "CHAIN DRUG MARKETING ASSOCIATION INC.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Dye-Free Ibuprofen", "active_ingredients": [{"name": "IBUPROFEN", "strength": "200 mg/1201"}], "application_number": "ANDA078682", "marketing_category": "ANDA", "marketing_start_date": "20211116", "listing_expiration_date": "20261231"}