naproxen sodium and diphenhydramine hcl

Generic: naproxen sodium and diphenhydramine hcl

Labeler: granules india ltd
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name naproxen sodium and diphenhydramine hcl
Generic Name naproxen sodium and diphenhydramine hcl
Labeler granules india ltd
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

diphenhydramine hydrochloride 25 mg/1, naproxen sodium 220 mg/1

Manufacturer
Granules India Ltd

Identifiers & Regulatory

Product NDC 62207-814
Product ID 62207-814_3b4ca636-ecbd-6807-e063-6294a90a7765
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA213663
Listing Expiration 2026-12-31
Marketing Start 2021-02-20

Pharmacologic Class

Classes
anti-inflammatory agents non-steroidal [cs] cyclooxygenase inhibitors [moa] histamine h1 receptor antagonists [moa] histamine-1 receptor antagonist [epc] nonsteroidal anti-inflammatory drug [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 62207814
Hyphenated Format 62207-814

Supplemental Identifiers

RxCUI
1550957
UNII
TC2D6JAD40 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 and diphenhydramine hcl (source: ndc)
Generic Name naproxen sodium and diphenhydramine hcl (source: ndc)
Application Number ANDA213663 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
  • 220 mg/1
source: ndc
Packaging
  • 37500 TABLET, FILM COATED in 1 POUCH (62207-814-38)
  • 7500 TABLET, FILM COATED in 1 POUCH (62207-814-39)
  • 500 TABLET, FILM COATED in 1 BOTTLE (62207-814-47)
  • 1 BOTTLE in 1 CARTON (62207-814-95) / 20 TABLET, FILM COATED in 1 BOTTLE
source: ndc

Packages (4)

62207-814-38 37500 TABLET, FILM COATED in 1 POUCH (62207-814-38) 62207-814-39 7500 TABLET, FILM COATED in 1 POUCH (62207-814-39) 62207-814-47 500 TABLET, FILM COATED in 1 BOTTLE (62207-814-47) 62207-814-95 1 BOTTLE in 1 CARTON (62207-814-95) / 20 TABLET, FILM COATED in 1 BOTTLE

Ingredients (2)

diphenhydramine hydrochloride (25 mg/1) naproxen sodium (220 mg/1)

Linked Drug Pages (1)

Naproxen Sodium and Diphenhydramine HCl ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3b4ca636-ecbd-6807-e063-6294a90a7765", "openfda": {"unii": ["TC2D6JAD40", "9TN87S3A3C"], "rxcui": ["1550957"], "spl_set_id": ["0d59780a-ef22-4b67-8b42-9795dbec8db0"], "manufacturer_name": ["Granules India Ltd"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "37500 TABLET, FILM COATED in 1 POUCH (62207-814-38)", "package_ndc": "62207-814-38", "marketing_start_date": "20210220"}, {"sample": false, "description": "7500 TABLET, FILM COATED in 1 POUCH (62207-814-39)", "package_ndc": "62207-814-39", "marketing_start_date": "20210220"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (62207-814-47)", "package_ndc": "62207-814-47", "marketing_start_date": "20210220"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (62207-814-95)  / 20 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "62207-814-95", "marketing_start_date": "20210220"}], "brand_name": "Naproxen Sodium and Diphenhydramine HCl", "product_id": "62207-814_3b4ca636-ecbd-6807-e063-6294a90a7765", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "62207-814", "generic_name": "Naproxen Sodium and Diphenhydramine HCl", "labeler_name": "Granules India Ltd", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Naproxen Sodium and Diphenhydramine HCl", "active_ingredients": [{"name": "DIPHENHYDRAMINE HYDROCHLORIDE", "strength": "25 mg/1"}, {"name": "NAPROXEN SODIUM", "strength": "220 mg/1"}], "application_number": "ANDA213663", "marketing_category": "ANDA", "marketing_start_date": "20210220", "listing_expiration_date": "20261231"}