ibuprofen

Generic: ibuprofen capsules 200 mg

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

Drug Facts

Product Profile

Brand Name ibuprofen
Generic Name ibuprofen capsules 200 mg
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 49483-133
Product ID 49483-133_059c51fc-6904-a427-e063-6294a90a7f69
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA079205
Listing Expiration 2026-12-31
Marketing Start 2021-07-27

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 49483133
Hyphenated Format 49483-133

Supplemental Identifiers

RxCUI
310964
UPC
0349483133370 0349483133202 0349483133318 0349483133127 0349483133806
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 capsules 200 mg (source: ndc)
Application Number ANDA079205 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 120 CAPSULE, LIQUID FILLED in 1 BOTTLE (49483-133-12)
  • 200 CAPSULE, LIQUID FILLED in 1 BOTTLE (49483-133-20)
  • 1 BOTTLE in 1 CARTON (49483-133-23) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE
  • 300 CAPSULE, LIQUID FILLED in 1 BOTTLE (49483-133-31)
  • 160 CAPSULE, LIQUID FILLED in 1 BOTTLE (49483-133-37)
  • 80 CAPSULE, LIQUID FILLED in 1 BOTTLE (49483-133-80)
source: ndc

Packages (6)

49483-133-12 120 CAPSULE, LIQUID FILLED in 1 BOTTLE (49483-133-12) 49483-133-20 200 CAPSULE, LIQUID FILLED in 1 BOTTLE (49483-133-20) 49483-133-23 1 BOTTLE in 1 CARTON (49483-133-23) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE 49483-133-31 300 CAPSULE, LIQUID FILLED in 1 BOTTLE (49483-133-31) 49483-133-37 160 CAPSULE, LIQUID FILLED in 1 BOTTLE (49483-133-37) 49483-133-80 80 CAPSULE, LIQUID FILLED in 1 BOTTLE (49483-133-80)

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": "059c51fc-6904-a427-e063-6294a90a7f69", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "upc": ["0349483133370", "0349483133202", "0349483133318", "0349483133127", "0349483133806"], "unii": ["WK2XYI10QM"], "rxcui": ["310964"], "spl_set_id": ["c7c51cf3-9e95-f8d0-e053-2995a90a7371"], "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": "120 CAPSULE, LIQUID FILLED in 1 BOTTLE (49483-133-12)", "package_ndc": "49483-133-12", "marketing_start_date": "20220616"}, {"sample": false, "description": "200 CAPSULE, LIQUID FILLED in 1 BOTTLE (49483-133-20)", "package_ndc": "49483-133-20", "marketing_start_date": "20220616"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (49483-133-23)  / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE", "package_ndc": "49483-133-23", "marketing_start_date": "20220616"}, {"sample": false, "description": "300 CAPSULE, LIQUID FILLED in 1 BOTTLE (49483-133-31)", "package_ndc": "49483-133-31", "marketing_start_date": "20210727"}, {"sample": false, "description": "160 CAPSULE, LIQUID FILLED in 1 BOTTLE (49483-133-37)", "package_ndc": "49483-133-37", "marketing_start_date": "20230916"}, {"sample": false, "description": "80 CAPSULE, LIQUID FILLED in 1 BOTTLE (49483-133-80)", "package_ndc": "49483-133-80", "marketing_start_date": "20220616"}], "brand_name": "Ibuprofen", "product_id": "49483-133_059c51fc-6904-a427-e063-6294a90a7f69", "dosage_form": "CAPSULE, LIQUID FILLED", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "49483-133", "generic_name": "Ibuprofen Capsules 200 mg", "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": "20210727", "listing_expiration_date": "20261231"}