pseudoephedrine hydrochloride

Generic: pseudoephedrine hydrochloride

Labeler: heb
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name pseudoephedrine hydrochloride
Generic Name pseudoephedrine hydrochloride
Labeler heb
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

pseudoephedrine hydrochloride 120 mg/1

Manufacturer
HEB

Identifiers & Regulatory

Product NDC 37808-007
Product ID 37808-007_66766915-1aef-4c72-8f47-f6074d2ab1ac
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA077442
Listing Expiration 2026-12-31
Marketing Start 2019-05-15

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 37808007
Hyphenated Format 37808-007

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 (37808-007-69) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
source: ndc

Packages (1)

37808-007-69 1 BLISTER PACK in 1 CARTON (37808-007-69) / 20 TABLET, EXTENDED RELEASE 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": "66766915-1aef-4c72-8f47-f6074d2ab1ac", "openfda": {"unii": ["6V9V2RYJ8N"], "rxcui": ["1049154"], "spl_set_id": ["d9b46ff2-8bde-47c0-bc63-b19dbe7e197b"], "manufacturer_name": ["HEB"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (37808-007-69)  / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "37808-007-69", "marketing_start_date": "20190515"}], "brand_name": "Pseudoephedrine Hydrochloride", "product_id": "37808-007_66766915-1aef-4c72-8f47-f6074d2ab1ac", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Adrenergic alpha-Agonists [MoA]", "alpha-Adrenergic Agonist [EPC]"], "product_ndc": "37808-007", "generic_name": "Pseudoephedrine Hydrochloride", "labeler_name": "HEB", "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": "20190515", "listing_expiration_date": "20261231"}