FDA.reportPublic FDA data

Propranolol Hydrochloride

Product NDC
0527-4116
11-digit product format
005274116
Labeler code
0527
Product ID
0527-4116_ceeffec9-095b-4081-b268-7869b0685921
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
propranolol hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Lannett Company, Inc.
Application
ANDA212026
Marketing category
ANDA
Marketing start
2020-01-06
Substance
PROPRANOLOL HYDROCHLORIDE
Active strength
60 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
Propranolol Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PROPRANOLOL HYDROCHLORIDE60 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF8A3652H1V
Rxcui856460, 856481, 856535, 856569

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
0527-4116-37Propranolol Hydrochloride100 in 1 BOTTLECAPSULE, EXTENDED RELEASE1009
0527-4116-41Propranolol Hydrochloride500 in 1 BOTTLECAPSULE, EXTENDED RELEASE5009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0527-4116-37EA - Each0527-41165e4a104b-a859-4da5-88e4-ba03ebcf23f212020-02-13
0527-4116-41EA - Each0527-41160901ea43-fe52-4257-a575-c694f187ff5712020-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0527-4116PROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [LANNETT COMPANY, INC.]9Current NDC, Legacy NDC, 2 package rows20240810_5229b561-287b-463c-8679-cda4c34f440b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856535propranolol HCl 60 MG 24HR Extended Release Oral CapsulePSNea98fedc-c440-487e-b144-35a8a389a446104
85653524 HR propranolol hydrochloride 60 MG Extended Release Oral CapsuleSCDea98fedc-c440-487e-b144-35a8a389a446104
856535propranolol hydrochloride 60 MG 24 HR Extended Release Oral CapsuleSYea98fedc-c440-487e-b144-35a8a389a446104
856460propranolol HCl 120 MG 24HR Extended Release Oral CapsulePSN5229b561-287b-463c-8679-cda4c34f440b9
856481propranolol HCl 160 MG 24HR Extended Release Oral CapsulePSN5229b561-287b-463c-8679-cda4c34f440b9
856535propranolol HCl 60 MG 24HR Extended Release Oral CapsulePSN5229b561-287b-463c-8679-cda4c34f440b9
856569propranolol HCl 80 MG 24HR Extended Release Oral CapsulePSN5229b561-287b-463c-8679-cda4c34f440b9
85646024 HR propranolol hydrochloride 120 MG Extended Release Oral CapsuleSCD5229b561-287b-463c-8679-cda4c34f440b9
85648124 HR propranolol hydrochloride 160 MG Extended Release Oral CapsuleSCD5229b561-287b-463c-8679-cda4c34f440b9
85653524 HR propranolol hydrochloride 60 MG Extended Release Oral CapsuleSCD5229b561-287b-463c-8679-cda4c34f440b9
85656924 HR propranolol hydrochloride 80 MG Extended Release Oral CapsuleSCD5229b561-287b-463c-8679-cda4c34f440b9
856460propranolol hydrochloride 120 MG 24 HR Extended Release Oral CapsuleSY5229b561-287b-463c-8679-cda4c34f440b9
856481propranolol hydrochloride 160 MG 24 HR Extended Release Oral CapsuleSY5229b561-287b-463c-8679-cda4c34f440b9
856535propranolol hydrochloride 60 MG 24 HR Extended Release Oral CapsuleSY5229b561-287b-463c-8679-cda4c34f440b9
856569propranolol hydrochloride 80 MG 24 HR Extended Release Oral CapsuleSY5229b561-287b-463c-8679-cda4c34f440b9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0527-4116-3700527411637100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0527-4116-37) 2020-01-060000-00-00NoNoCurrent
0527-4116-4100527411641500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0527-4116-41) 2020-01-060000-00-00NoNoCurrent