inderal xl

Generic: propranolol hydrochloride

Labeler: ani pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name inderal xl
Generic Name propranolol hydrochloride
Labeler ani pharmaceuticals, inc.
Dosage Form CAPSULE, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

propranolol hydrochloride 120 mg/1

Manufacturer
ANI Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 62559-601
Product ID 62559-601_2b2778d4-efb2-4541-8264-375ad6082cb6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021438
Listing Expiration 2026-12-31
Marketing Start 2018-02-22

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 62559601
Hyphenated Format 62559-601

Supplemental Identifiers

RxCUI
856460 856462 856569 856571
UPC
0362559601306 0362559600309
UNII
F8A3652H1V

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 inderal xl (source: ndc)
Generic Name propranolol hydrochloride (source: ndc)
Application Number NDA021438 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 120 mg/1
source: ndc
Packaging
  • 14 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62559-601-14)
  • 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62559-601-30)
  • 7 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62559-601-77)
source: ndc

Packages (3)

62559-601-14 14 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62559-601-14) 62559-601-30 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62559-601-30) 62559-601-77 7 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62559-601-77)

Ingredients (1)

propranolol hydrochloride (120 mg/1)

Linked Drug Pages (1)

Inderal XL ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2b2778d4-efb2-4541-8264-375ad6082cb6", "openfda": {"upc": ["0362559601306", "0362559600309"], "unii": ["F8A3652H1V"], "rxcui": ["856460", "856462", "856569", "856571"], "spl_set_id": ["ac196ff5-9215-402b-bc57-69aa87f8bade"], "manufacturer_name": ["ANI Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "14 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62559-601-14)", "package_ndc": "62559-601-14", "marketing_start_date": "20210901"}, {"sample": false, "description": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62559-601-30)", "package_ndc": "62559-601-30", "marketing_start_date": "20180222"}, {"sample": false, "description": "7 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62559-601-77)", "package_ndc": "62559-601-77", "marketing_start_date": "20180222"}], "brand_name": "Inderal XL", "product_id": "62559-601_2b2778d4-efb2-4541-8264-375ad6082cb6", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "62559-601", "generic_name": "propranolol hydrochloride", "labeler_name": "ANI Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Inderal XL", "active_ingredients": [{"name": "PROPRANOLOL HYDROCHLORIDE", "strength": "120 mg/1"}], "application_number": "NDA021438", "marketing_category": "NDA", "marketing_start_date": "20180222", "listing_expiration_date": "20261231"}