Labetalol Hydrochloride

Generic: Labetalol Hydrochloride

Labeler: Eywa Pharma Inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Active

Drug Facts

Product Profile

Brand Name Labetalol Hydrochloride
Generic Name Labetalol Hydrochloride
Labeler Eywa Pharma Inc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

LABETALOL HYDROCHLORIDE 300 mg/1

Identifiers & Regulatory

Product NDC 71930-037
Product ID 71930-037_d923d8d6-a2c9-4afa-a1c2-67afddd5af1a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207863
Listing Expiration 2026-12-31
Marketing Start 2019-05-24

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71930037
Hyphenated Format 71930-037

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 Labetalol Hydrochloride (source: ndc)
Generic Name Labetalol Hydrochloride (source: ndc)
Application Number ANDA207863 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (71930-037-12)
  • 500 TABLET, FILM COATED in 1 BOTTLE (71930-037-52)
source: ndc

Packages (2)

71930-037-12 100 TABLET, FILM COATED in 1 BOTTLE (71930-037-12) 71930-037-52 500 TABLET, FILM COATED in 1 BOTTLE (71930-037-52)

Ingredients (1)

LABETALOL HYDROCHLORIDE (300 mg/1)

Linked Drug Pages (1)

Labetalol Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "d923d8d6-a2c9-4afa-a1c2-67afddd5af1a", "openfda": {"unii": ["1GEV3BAW9J"], "rxcui": ["896758", "896762", "896766"], "spl_set_id": ["891c42c0-6071-5d85-e053-2995a90a4294"], "manufacturer_name": ["Eywa Pharma Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (71930-037-12)", "package_ndc": "71930-037-12", "marketing_start_date": "20190524"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (71930-037-52)", "package_ndc": "71930-037-52", "marketing_start_date": "20190524"}], "brand_name": "Labetalol Hydrochloride", "product_id": "71930-037_d923d8d6-a2c9-4afa-a1c2-67afddd5af1a", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "71930-037", "generic_name": "Labetalol Hydrochloride", "labeler_name": "Eywa Pharma Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Labetalol Hydrochloride", "active_ingredients": [{"name": "LABETALOL HYDROCHLORIDE", "strength": "300 mg/1"}], "application_number": "ANDA207863", "marketing_category": "ANDA", "marketing_start_date": "20190524", "listing_expiration_date": "20261231"}