FDA.reportPublic FDA data

INDERAL

Product NDC
62559-521
11-digit product format
625590521
Labeler code
62559
Product ID
62559-521_ca8f11e2-bf38-474e-9929-43c522be09ea
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
propranolol hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
ANI Pharmaceuticals, Inc.
Application
NDA018553
Marketing category
NDA
Marketing start
2017-04-28
Substance
PROPRANOLOL HYDROCHLORIDE
Active strength
80 mg/1
Pharmacologic classes
Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
INDERAL
Brand name suffix
LA
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PROPRANOLOL HYDROCHLORIDE80 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF8A3652H1V
Rxcui856460, 856462, 856481, 856483, 856535, 856537, 856569, 856571

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ba1babb5-1c2a-d9a8-0fd7-8f90d4f768cfProduct name220200609
a5696e6c-a559-4d6b-bb53-f324106f317cProduct name120140718
0f446d3d-c9e6-1844-b8e8-a836dc35e0deProduct name120140508
33a4b7b4-a3c1-3f95-a202-01166dd77c44Product name120140508
60519d27-227d-404a-38bc-37524c8b386bProduct name120140508
d5f30598-8f94-b083-f161-65d67f2ae12aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62559-521-01INDERALLA100 in 1 BOTTLECAPSULE, EXTENDED RELEASE10010
62559-521-30INDERALLA30 in 1 BOTTLECAPSULE, EXTENDED RELEASE3010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62559-521-01EA - Each62559-52183610ede-92c7-4116-80c7-342e46a614a812017-06-15
62559-521-30EA - Each62559-52116e8dd46-a73b-4409-95f4-7896b95fab5d12024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62559-521INDERAL LA (PROPRANOLOL HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [ANI PHARMACEUTICALS, INC.]10Current NDC, Legacy NDC, 2 package rows20240802_35d28979-36b1-4630-b85e-a44e0a443734.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856462Inderal LA 120 MG 24HR Extended Release Oral CapsulePSN35d28979-36b1-4630-b85e-a44e0a44373410
856483Inderal LA 160 MG 24HR Extended Release Oral CapsulePSN35d28979-36b1-4630-b85e-a44e0a44373410
856537Inderal LA 60 MG 24HR Extended Release Oral CapsulePSN35d28979-36b1-4630-b85e-a44e0a44373410
856571Inderal LA 80 MG 24HR Extended Release Oral CapsulePSN35d28979-36b1-4630-b85e-a44e0a44373410
856460propranolol HCl 120 MG 24HR Extended Release Oral CapsulePSN35d28979-36b1-4630-b85e-a44e0a44373410
856481propranolol HCl 160 MG 24HR Extended Release Oral CapsulePSN35d28979-36b1-4630-b85e-a44e0a44373410
856535propranolol HCl 60 MG 24HR Extended Release Oral CapsulePSN35d28979-36b1-4630-b85e-a44e0a44373410
856569propranolol HCl 80 MG 24HR Extended Release Oral CapsulePSN35d28979-36b1-4630-b85e-a44e0a44373410
85646224 HR propranolol hydrochloride 120 MG Extended Release Oral Capsule [Inderal]SBD35d28979-36b1-4630-b85e-a44e0a44373410
85648324 HR propranolol hydrochloride 160 MG Extended Release Oral Capsule [Inderal]SBD35d28979-36b1-4630-b85e-a44e0a44373410
85653724 HR propranolol hydrochloride 60 MG Extended Release Oral Capsule [Inderal]SBD35d28979-36b1-4630-b85e-a44e0a44373410
85657124 HR propranolol hydrochloride 80 MG Extended Release Oral Capsule [Inderal]SBD35d28979-36b1-4630-b85e-a44e0a44373410
85646024 HR propranolol hydrochloride 120 MG Extended Release Oral CapsuleSCD35d28979-36b1-4630-b85e-a44e0a44373410
85648124 HR propranolol hydrochloride 160 MG Extended Release Oral CapsuleSCD35d28979-36b1-4630-b85e-a44e0a44373410
85653524 HR propranolol hydrochloride 60 MG Extended Release Oral CapsuleSCD35d28979-36b1-4630-b85e-a44e0a44373410
85656924 HR propranolol hydrochloride 80 MG Extended Release Oral CapsuleSCD35d28979-36b1-4630-b85e-a44e0a44373410
85648324 HR Inderal LA 160 MG Extended Release Oral CapsuleSY35d28979-36b1-4630-b85e-a44e0a44373410
85653724 HR Inderal LA 60 MG Extended Release Oral CapsuleSY35d28979-36b1-4630-b85e-a44e0a44373410
856483Inderal LA 160 MG 24 HR Extended Release Oral CapsuleSY35d28979-36b1-4630-b85e-a44e0a44373410
856537Inderal LA 60 MG 24 HR Extended Release Oral CapsuleSY35d28979-36b1-4630-b85e-a44e0a44373410
856462Inderal XL 120 MG 24 HR Extended Release Oral CapsuleSY35d28979-36b1-4630-b85e-a44e0a44373410
856571Inderal XL 80 MG 24 HR Extended Release Oral CapsuleSY35d28979-36b1-4630-b85e-a44e0a44373410
856460propranolol hydrochloride 120 MG 24 HR Extended Release Oral CapsuleSY35d28979-36b1-4630-b85e-a44e0a44373410
856481propranolol hydrochloride 160 MG 24 HR Extended Release Oral CapsuleSY35d28979-36b1-4630-b85e-a44e0a44373410
856535propranolol hydrochloride 60 MG 24 HR Extended Release Oral CapsuleSY35d28979-36b1-4630-b85e-a44e0a44373410
856569propranolol hydrochloride 80 MG 24 HR Extended Release Oral CapsuleSY35d28979-36b1-4630-b85e-a44e0a44373410

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
62559-521-0162559052101100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62559-521-01) 2017-04-280000-00-00NoNoCurrent
62559-521-306255905213030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62559-521-30) 2024-08-05NoNoHistorical