pseudoephedrine hydrochloride

Generic: pseudoephedrine hydrochloride

Labeler: strategic sourcing services llc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name pseudoephedrine hydrochloride
Generic Name pseudoephedrine hydrochloride
Labeler strategic sourcing services llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

pseudoephedrine hydrochloride 120 mg/1

Manufacturer
STRATEGIC SOURCING SERVICES LLC

Identifiers & Regulatory

Product NDC 70677-1019
Product ID 70677-1019_a8f13ce3-e26c-4c8e-9946-bcc08d1a64bb
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA077442
Listing Expiration 2026-12-31
Marketing Start 2023-08-10

Pharmacologic Class

Classes
adrenergic alpha-agonists [moa] alpha-adrenergic agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 706771019
Hyphenated Format 70677-1019

Supplemental Identifiers

RxCUI
1049154
UNII
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 pseudoephedrine hydrochloride (source: ndc)
Generic Name pseudoephedrine hydrochloride (source: ndc)
Application Number ANDA077442 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 120 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (70677-1019-1) / 10 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (1)

70677-1019-1 1 BLISTER PACK in 1 CARTON (70677-1019-1) / 10 TABLET, FILM COATED in 1 BLISTER PACK

Ingredients (1)

pseudoephedrine hydrochloride (120 mg/1)

Linked Drug Pages (1)

Pseudoephedrine hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "a8f13ce3-e26c-4c8e-9946-bcc08d1a64bb", "openfda": {"unii": ["6V9V2RYJ8N"], "rxcui": ["1049154"], "spl_set_id": ["3bf95c58-4fd9-4caa-a54f-2e61a5eacae8"], "manufacturer_name": ["STRATEGIC SOURCING SERVICES LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (70677-1019-1)  / 10 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "70677-1019-1", "marketing_start_date": "20230810"}], "brand_name": "Pseudoephedrine hydrochloride", "product_id": "70677-1019_a8f13ce3-e26c-4c8e-9946-bcc08d1a64bb", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Adrenergic alpha-Agonists [MoA]", "alpha-Adrenergic Agonist [EPC]"], "product_ndc": "70677-1019", "generic_name": "Pseudoephedrine hydrochloride", "labeler_name": "STRATEGIC SOURCING SERVICES LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Pseudoephedrine hydrochloride", "active_ingredients": [{"name": "PSEUDOEPHEDRINE HYDROCHLORIDE", "strength": "120 mg/1"}], "application_number": "ANDA077442", "marketing_category": "ANDA", "marketing_start_date": "20230810", "listing_expiration_date": "20261231"}