labetalol hcl

Generic: labetalol hydrochloride

Labeler: par health usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name labetalol hcl
Generic Name labetalol hydrochloride
Labeler par health usa, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

labetalol hydrochloride 200 mg/1

Manufacturer
Par Health USA, LLC

Identifiers & Regulatory

Product NDC 49884-123
Product ID 49884-123_c44ec282-63ce-491d-8842-7050d099a6e4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA200908
Marketing Start 2012-07-24
Marketing End 2026-04-30

Pharmacologic Class

Classes
adrenergic beta-antagonists [moa] beta-adrenergic blocker [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 49884123
Hyphenated Format 49884-123

Supplemental Identifiers

RxCUI
896758 896762 896766
UNII
1GEV3BAW9J

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 labetalol hcl (source: ndc)
Generic Name labetalol hydrochloride (source: ndc)
Application Number ANDA200908 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (49884-123-01)
  • 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (49884-123-05)
source: ndc

Packages (2)

49884-123-01 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (49884-123-01) 49884-123-05 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (49884-123-05)

Ingredients (1)

labetalol hydrochloride (200 mg/1)

Linked Drug Pages (1)

Labetalol HCL ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "c44ec282-63ce-491d-8842-7050d099a6e4", "openfda": {"unii": ["1GEV3BAW9J"], "rxcui": ["896758", "896762", "896766"], "spl_set_id": ["56ab2ff4-14a6-4297-afd8-56b92e1f64a0"], "manufacturer_name": ["Par Health USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (49884-123-01)", "package_ndc": "49884-123-01", "marketing_end_date": "20260331", "marketing_start_date": "20120724"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (49884-123-05)", "package_ndc": "49884-123-05", "marketing_end_date": "20260430", "marketing_start_date": "20120724"}], "brand_name": "Labetalol HCL", "product_id": "49884-123_c44ec282-63ce-491d-8842-7050d099a6e4", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "49884-123", "generic_name": "Labetalol Hydrochloride", "labeler_name": "Par Health USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Labetalol HCL", "active_ingredients": [{"name": "LABETALOL HYDROCHLORIDE", "strength": "200 mg/1"}], "application_number": "ANDA200908", "marketing_category": "ANDA", "marketing_end_date": "20260430", "marketing_start_date": "20120724"}