ibuprofen

Generic: ibuprofen

Labeler: puracap pharmaceutical llc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ibuprofen
Generic Name ibuprofen
Labeler puracap pharmaceutical llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

ibuprofen 200 mg/1

Manufacturer
PuraCap Pharmaceutical LLC

Identifiers & Regulatory

Product NDC 51013-319
Product ID 51013-319_127ceac7-923c-47f4-a768-47f7e46b2e97
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA079174
Listing Expiration 2026-12-31
Marketing Start 2017-11-09

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 51013319
Hyphenated Format 51013-319

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 ibuprofen (source: ndc)
Generic Name ibuprofen (source: ndc)
Application Number ANDA079174 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 15 POUCH in 1 CARTON (51013-319-54) / 2 TABLET in 1 POUCH
source: ndc

Packages (1)

51013-319-54 15 POUCH in 1 CARTON (51013-319-54) / 2 TABLET in 1 POUCH

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": "127ceac7-923c-47f4-a768-47f7e46b2e97", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["WK2XYI10QM"], "rxcui": ["310965"], "spl_set_id": ["acc4cbc8-085d-42f3-ad93-113e0b55631c"], "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": ["PuraCap Pharmaceutical LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "15 POUCH in 1 CARTON (51013-319-54)  / 2 TABLET in 1 POUCH", "package_ndc": "51013-319-54", "marketing_start_date": "20171109"}], "brand_name": "Ibuprofen", "product_id": "51013-319_127ceac7-923c-47f4-a768-47f7e46b2e97", "dosage_form": "TABLET", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "51013-319", "generic_name": "Ibuprofen", "labeler_name": "PuraCap Pharmaceutical LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Ibuprofen", "active_ingredients": [{"name": "IBUPROFEN", "strength": "200 mg/1"}], "application_number": "ANDA079174", "marketing_category": "ANDA", "marketing_start_date": "20171109", "listing_expiration_date": "20261231"}