ibuprofen

Generic: ibuprofen

Labeler: time cap laboratories, inc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ibuprofen
Generic Name ibuprofen
Labeler time cap laboratories, inc
Dosage Form CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients

ibuprofen 200 mg/1

Manufacturer
TIME CAP LABORATORIES, INC

Identifiers & Regulatory

Product NDC 49483-610
Product ID 49483-610_471706f7-1fc3-7979-e063-6294a90a54c2
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA079205
Listing Expiration 2026-12-31
Marketing Start 2015-12-23

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 49483610
Hyphenated Format 49483-610

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 ibuprofen (source: ndc)
Generic Name ibuprofen (source: ndc)
Application Number ANDA079205 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 40 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (49483-610-44)
source: ndc

Packages (1)

Ingredients (1)

ibuprofen (200 mg/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "471706f7-1fc3-7979-e063-6294a90a54c2", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["WK2XYI10QM"], "rxcui": ["310964"], "spl_set_id": ["e0a8315a-80a5-4be3-aad1-3d01f00df494"], "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": ["TIME CAP LABORATORIES, INC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "40 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (49483-610-44)", "package_ndc": "49483-610-44", "marketing_start_date": "20151223"}], "brand_name": "IBUPROFEN", "product_id": "49483-610_471706f7-1fc3-7979-e063-6294a90a54c2", "dosage_form": "CAPSULE, LIQUID FILLED", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "49483-610", "generic_name": "IBUPROFEN", "labeler_name": "TIME CAP LABORATORIES, INC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "IBUPROFEN", "active_ingredients": [{"name": "IBUPROFEN", "strength": "200 mg/1"}], "application_number": "ANDA079205", "marketing_category": "ANDA", "marketing_start_date": "20151223", "listing_expiration_date": "20261231"}