rapidol naproxen

Generic: naproxen sodium

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

Drug Facts

Product Profile

Brand Name rapidol naproxen
Generic Name naproxen sodium
Labeler pharmadel llc
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

naproxen sodium 220 mg/1

Manufacturer
Pharmadel LLC

Identifiers & Regulatory

Product NDC 55758-048
Product ID 55758-048_2d5725c3-b1fc-ac59-e063-6294a90a3f6e
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA091353
Listing Expiration 2026-12-31
Marketing Start 2019-10-09

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 55758048
Hyphenated Format 55758-048

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 rapidol naproxen (source: ndc)
Generic Name naproxen sodium (source: ndc)
Application Number ANDA091353 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 220 mg/1
source: ndc
Packaging
  • 2 TABLET, COATED in 1 PACKET (55758-048-02)
  • 1 BOTTLE in 1 CARTON (55758-048-24) / 24 TABLET, COATED in 1 BOTTLE
  • 25 PACKET in 1 CARTON (55758-048-50) / 2 TABLET, COATED in 1 PACKET (55758-048-02)
source: ndc

Packages (3)

Ingredients (1)

naproxen sodium (220 mg/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "2d5725c3-b1fc-ac59-e063-6294a90a3f6e", "openfda": {"unii": ["9TN87S3A3C"], "rxcui": ["849574"], "spl_set_id": ["c94c4b6e-a48b-cee5-e053-2995a90a49ac"], "manufacturer_name": ["Pharmadel LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 TABLET, COATED in 1 PACKET (55758-048-02)", "package_ndc": "55758-048-02", "marketing_start_date": "20231024"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (55758-048-24)  / 24 TABLET, COATED in 1 BOTTLE", "package_ndc": "55758-048-24", "marketing_start_date": "20191009"}, {"sample": false, "description": "25 PACKET in 1 CARTON (55758-048-50)  / 2 TABLET, COATED in 1 PACKET (55758-048-02)", "package_ndc": "55758-048-50", "marketing_start_date": "20231024"}], "brand_name": "Rapidol Naproxen", "product_id": "55758-048_2d5725c3-b1fc-ac59-e063-6294a90a3f6e", "dosage_form": "TABLET, COATED", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "55758-048", "generic_name": "Naproxen sodium", "labeler_name": "Pharmadel LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Rapidol Naproxen", "active_ingredients": [{"name": "NAPROXEN SODIUM", "strength": "220 mg/1"}], "application_number": "ANDA091353", "marketing_category": "ANDA", "marketing_start_date": "20191009", "listing_expiration_date": "20261231"}