naproxen sodium

Generic: naproxen sodium

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

Drug Facts

Product Profile

Brand Name naproxen sodium
Generic Name naproxen sodium
Labeler time cap laboratories, inc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

naproxen sodium 220 mg/1

Manufacturer
TIME CAP LABORATORIES, INC

Identifiers & Regulatory

Product NDC 49483-608
Product ID 49483-608_0538c5c7-c559-4ea9-e063-6294a90aec21
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA090545
Listing Expiration 2026-12-31
Marketing Start 2016-03-28

Pharmacologic Class

Classes
anti-inflammatory agents non-steroidal [cs] cyclooxygenase inhibitors [moa] nonsteroidal anti-inflammatory drug [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 49483608
Hyphenated Format 49483-608

Supplemental Identifiers

RxCUI
849574
UPC
0349483608014 0349483608311
UNII
9TN87S3A3C

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 naproxen sodium (source: ndc)
Generic Name naproxen sodium (source: ndc)
Application Number ANDA090545 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 220 mg/1
source: ndc
Packaging
  • 6500 TABLET, FILM COATED in 1 BAG (49483-608-00)
  • 100 TABLET, FILM COATED in 1 BOTTLE (49483-608-01)
  • 50 TABLET, FILM COATED in 1 BOTTLE (49483-608-05)
  • 300 TABLET, FILM COATED in 1 BOTTLE (49483-608-31)
source: ndc

Packages (4)

49483-608-00 6500 TABLET, FILM COATED in 1 BAG (49483-608-00) 49483-608-01 100 TABLET, FILM COATED in 1 BOTTLE (49483-608-01) 49483-608-05 50 TABLET, FILM COATED in 1 BOTTLE (49483-608-05) 49483-608-31 300 TABLET, FILM COATED in 1 BOTTLE (49483-608-31)

Ingredients (1)

naproxen sodium (220 mg/1)

Linked Drug Pages (1)

NAPROXEN SODIUM ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "0538c5c7-c559-4ea9-e063-6294a90aec21", "openfda": {"upc": ["0349483608014", "0349483608311"], "unii": ["9TN87S3A3C"], "rxcui": ["849574"], "spl_set_id": ["ab7b7b8e-923b-4dc1-812c-78e85de1bee1"], "manufacturer_name": ["TIME CAP LABORATORIES, INC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "6500 TABLET, FILM COATED in 1 BAG (49483-608-00)", "package_ndc": "49483-608-00", "marketing_start_date": "20160328"}, {"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (49483-608-01)", "package_ndc": "49483-608-01", "marketing_start_date": "20160328"}, {"sample": false, "description": "50 TABLET, FILM COATED in 1 BOTTLE (49483-608-05)", "package_ndc": "49483-608-05", "marketing_start_date": "20160328"}, {"sample": false, "description": "300 TABLET, FILM COATED in 1 BOTTLE (49483-608-31)", "package_ndc": "49483-608-31", "marketing_start_date": "20230808"}], "brand_name": "NAPROXEN SODIUM", "product_id": "49483-608_0538c5c7-c559-4ea9-e063-6294a90aec21", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "49483-608", "generic_name": "NAPROXEN SODIUM", "labeler_name": "TIME CAP LABORATORIES, INC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "NAPROXEN SODIUM", "active_ingredients": [{"name": "NAPROXEN SODIUM", "strength": "220 mg/1"}], "application_number": "ANDA090545", "marketing_category": "ANDA", "marketing_start_date": "20160328", "listing_expiration_date": "20261231"}