leader all day sinus and cold d

Generic: naproxen sodium, pseudoephedrine hcl

Labeler: cardinal health 110, llc. dba leader
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name leader all day sinus and cold d
Generic Name naproxen sodium, pseudoephedrine hcl
Labeler cardinal health 110, llc. dba leader
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

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

Manufacturer
Cardinal Health 110, LLC. dba Leader

Identifiers & Regulatory

Product NDC 70000-0605
Product ID 70000-0605_4d33af2f-53b6-49d2-927b-55d7f9273103
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA076518
Listing Expiration 2026-12-31
Marketing Start 2022-05-19

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 700000605
Hyphenated Format 70000-0605

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 leader all day sinus and cold d (source: ndc)
Generic Name naproxen sodium, pseudoephedrine hcl (source: ndc)
Application Number ANDA076518 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 220 mg/1
  • 120 mg/1
source: ndc
Packaging
  • 20 BLISTER PACK in 1 CARTON (70000-0605-1) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
source: ndc

Packages (1)

70000-0605-1 20 BLISTER PACK in 1 CARTON (70000-0605-1) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK

Ingredients (2)

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

Linked Drug Pages (1)

Leader All Day Sinus and Cold D ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4d33af2f-53b6-49d2-927b-55d7f9273103", "openfda": {"unii": ["9TN87S3A3C", "6V9V2RYJ8N"], "rxcui": ["1367426"], "spl_set_id": ["83f7cfbb-ab84-4594-ae7a-4a657385c8a7"], "manufacturer_name": ["Cardinal Health 110, LLC. dba Leader"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "20 BLISTER PACK in 1 CARTON (70000-0605-1)  / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "70000-0605-1", "marketing_start_date": "20220519"}], "brand_name": "Leader All Day Sinus and Cold D", "product_id": "70000-0605_4d33af2f-53b6-49d2-927b-55d7f9273103", "dosage_form": "TABLET, FILM COATED, 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": "70000-0605", "generic_name": "Naproxen sodium, Pseudoephedrine HCl", "labeler_name": "Cardinal Health 110, LLC. dba Leader", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Leader All Day Sinus and Cold D", "active_ingredients": [{"name": "NAPROXEN SODIUM", "strength": "220 mg/1"}, {"name": "PSEUDOEPHEDRINE HYDROCHLORIDE", "strength": "120 mg/1"}], "application_number": "ANDA076518", "marketing_category": "ANDA", "marketing_start_date": "20220519", "listing_expiration_date": "20261231"}