anadent

Generic: naproxen sodium

Labeler: belmora llc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name anadent
Generic Name naproxen sodium
Labeler belmora llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

naproxen sodium 220 mg/1

Manufacturer
Belmora LLC

Identifiers & Regulatory

Product NDC 27854-170
Product ID 27854-170_16b93df8-98f1-4fad-96a7-f814ff0c084a
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA204872
Listing Expiration 2026-12-31
Marketing Start 2017-01-23

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 27854170
Hyphenated Format 27854-170

Supplemental Identifiers

RxCUI
849574
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 anadent (source: ndc)
Generic Name naproxen sodium (source: ndc)
Application Number ANDA204872 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 220 mg/1
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 CARTON (27854-170-01) / 24 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
source: ndc

Packages (1)

27854-170-01 1 BOTTLE, PLASTIC in 1 CARTON (27854-170-01) / 24 TABLET, FILM COATED in 1 BOTTLE, PLASTIC

Ingredients (1)

naproxen sodium (220 mg/1)

Linked Drug Pages (1)

AnaDent ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "16b93df8-98f1-4fad-96a7-f814ff0c084a", "openfda": {"unii": ["9TN87S3A3C"], "rxcui": ["849574"], "spl_set_id": ["236674db-da4d-415c-a160-7086eaf5bff5"], "manufacturer_name": ["Belmora LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (27854-170-01)  / 24 TABLET, FILM COATED in 1 BOTTLE, PLASTIC", "package_ndc": "27854-170-01", "marketing_start_date": "20170123"}], "brand_name": "AnaDent", "product_id": "27854-170_16b93df8-98f1-4fad-96a7-f814ff0c084a", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "27854-170", "generic_name": "Naproxen Sodium", "labeler_name": "Belmora LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "AnaDent", "active_ingredients": [{"name": "NAPROXEN SODIUM", "strength": "220 mg/1"}], "application_number": "ANDA204872", "marketing_category": "ANDA", "marketing_start_date": "20170123", "listing_expiration_date": "20261231"}