naproxen sodium and pseudoephedrine hydrochloride sinus and cold

Generic: naproxen sodium and pseudoephedrine hydrochloride

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

Drug Facts

Product Profile

Brand Name naproxen sodium and pseudoephedrine hydrochloride sinus and cold
Generic Name naproxen sodium and pseudoephedrine hydrochloride
Labeler aurohealth llc
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

naproxen sodium 220 mg/1, pseudoephedrine hydrochloride 120 mg/1

Manufacturer
Aurohealth LLC

Identifiers & Regulatory

Product NDC 58602-816
Product ID 58602-816_554a4cb1-aaac-44f9-99c7-f342abdc3531
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA211360
Listing Expiration 2026-12-31
Marketing Start 2022-06-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 58602816
Hyphenated Format 58602-816

Supplemental Identifiers

RxCUI
1367426
UNII
9TN87S3A3C 6V9V2RYJ8N

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 pseudoephedrine hydrochloride sinus and cold (source: ndc)
Generic Name naproxen sodium and pseudoephedrine hydrochloride (source: ndc)
Application Number ANDA211360 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 220 mg/1
  • 120 mg/1
source: ndc
Packaging
  • 2 BLISTER PACK in 1 CARTON (58602-816-67) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
  • 3 BLISTER PACK in 1 CARTON (58602-816-72) / 8 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
  • 1 BLISTER PACK in 1 CARTON (58602-816-83) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
source: ndc

Packages (3)

58602-816-67 2 BLISTER PACK in 1 CARTON (58602-816-67) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK 58602-816-72 3 BLISTER PACK in 1 CARTON (58602-816-72) / 8 TABLET, EXTENDED RELEASE in 1 BLISTER PACK 58602-816-83 1 BLISTER PACK in 1 CARTON (58602-816-83) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

Ingredients (2)

naproxen sodium (220 mg/1) pseudoephedrine hydrochloride (120 mg/1)

Linked Drug Pages (1)

Naproxen Sodium and Pseudoephedrine Hydrochloride Sinus and Cold ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "554a4cb1-aaac-44f9-99c7-f342abdc3531", "openfda": {"unii": ["9TN87S3A3C", "6V9V2RYJ8N"], "rxcui": ["1367426"], "spl_set_id": ["638a9664-4129-46fd-9ba1-d660a7366c9f"], "manufacturer_name": ["Aurohealth LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BLISTER PACK in 1 CARTON (58602-816-67)  / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "58602-816-67", "marketing_start_date": "20220601"}, {"sample": false, "description": "3 BLISTER PACK in 1 CARTON (58602-816-72)  / 8 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "58602-816-72", "marketing_start_date": "20250212"}, {"sample": false, "description": "1 BLISTER PACK in 1 CARTON (58602-816-83)  / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "58602-816-83", "marketing_start_date": "20220601"}], "brand_name": "Naproxen Sodium and Pseudoephedrine Hydrochloride Sinus and Cold", "product_id": "58602-816_554a4cb1-aaac-44f9-99c7-f342abdc3531", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Adrenergic alpha-Agonists [MoA]", "Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]", "alpha-Adrenergic Agonist [EPC]"], "product_ndc": "58602-816", "generic_name": "Naproxen Sodium and Pseudoephedrine Hydrochloride", "labeler_name": "Aurohealth LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Naproxen Sodium and Pseudoephedrine Hydrochloride Sinus and Cold", "active_ingredients": [{"name": "NAPROXEN SODIUM", "strength": "220 mg/1"}, {"name": "PSEUDOEPHEDRINE HYDROCHLORIDE", "strength": "120 mg/1"}], "application_number": "ANDA211360", "marketing_category": "ANDA", "marketing_start_date": "20220601", "listing_expiration_date": "20261231"}