valumeds ibuprofen

Generic: ibuprofen

Labeler: spirit pharmaceuticals llc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name valumeds ibuprofen
Generic Name ibuprofen
Labeler spirit pharmaceuticals llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

ibuprofen 200 mg/1

Manufacturer
SPIRIT PHARMACEUTICALS LLC

Identifiers & Regulatory

Product NDC 68210-0800
Product ID 68210-0800_28ed10e2-9113-a062-e063-6394a90a0ba3
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA091239
Listing Expiration 2026-12-31
Marketing Start 2017-05-19

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 682100800
Hyphenated Format 68210-0800

Supplemental Identifiers

RxCUI
310965
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 valumeds ibuprofen (source: ndc)
Generic Name ibuprofen (source: ndc)
Application Number ANDA091239 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (68210-0800-1)
  • 1 BOTTLE in 1 CARTON (68210-0800-4) / 40 TABLET, FILM COATED in 1 BOTTLE
source: ndc

Packages (2)

68210-0800-1 100 TABLET, FILM COATED in 1 BOTTLE (68210-0800-1) 68210-0800-4 1 BOTTLE in 1 CARTON (68210-0800-4) / 40 TABLET, FILM COATED in 1 BOTTLE

Ingredients (1)

ibuprofen (200 mg/1)

Linked Drug Pages (1)

VALUMEDS IBUPROFEN ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "28ed10e2-9113-a062-e063-6394a90a0ba3", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["WK2XYI10QM"], "rxcui": ["310965"], "spl_set_id": ["a6d4ceb0-2b79-496a-aa1e-27edd507ced0"], "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": ["SPIRIT PHARMACEUTICALS LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (68210-0800-1)", "package_ndc": "68210-0800-1", "marketing_start_date": "20170519"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (68210-0800-4)  / 40 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "68210-0800-4", "marketing_start_date": "20180411"}], "brand_name": "VALUMEDS IBUPROFEN", "product_id": "68210-0800_28ed10e2-9113-a062-e063-6394a90a0ba3", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "68210-0800", "generic_name": "IBUPROFEN", "labeler_name": "SPIRIT PHARMACEUTICALS LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "VALUMEDS IBUPROFEN", "active_ingredients": [{"name": "IBUPROFEN", "strength": "200 mg/1"}], "application_number": "ANDA091239", "marketing_category": "ANDA", "marketing_start_date": "20170519", "listing_expiration_date": "20261231"}