FDA.reportPublic FDA data

Propranolol Hydrochloride

Product NDC
0527-4117
11-digit product format
005274117
Labeler code
0527
Product ID
0527-4117_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
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
Propranolol Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PROPRANOLOL HYDROCHLORIDE80 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
0527-4117-37Propranolol Hydrochloride100 in 1 BOTTLECAPSULE, EXTENDED RELEASE1009
0527-4117-41Propranolol Hydrochloride500 in 1 BOTTLECAPSULE, EXTENDED RELEASE5009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0527-4117-37EA - Each0527-411741b24c18-c076-48c8-b660-e1dc290fdb0a12020-02-13
0527-4117-41EA - Each0527-41177d0653ae-cd87-42f1-9aec-a4c742a218c812020-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0527-4117PROPRANOLOL 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
856569propranolol HCl 80 MG 24HR Extended Release Oral CapsulePSNb9d12ace-7e30-4183-99a4-c0a5a6a55cdf104
85656924 HR propranolol hydrochloride 80 MG Extended Release Oral CapsuleSCDb9d12ace-7e30-4183-99a4-c0a5a6a55cdf104
856569propranolol hydrochloride 80 MG 24 HR Extended Release Oral CapsuleSYb9d12ace-7e30-4183-99a4-c0a5a6a55cdf104
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
856569propranolol HCl 80 MG 24HR Extended Release Oral CapsulePSN414c4b69-38a1-4220-bec8-204c9a624b856
85656924 HR propranolol hydrochloride 80 MG Extended Release Oral CapsuleSCD414c4b69-38a1-4220-bec8-204c9a624b856
856569propranolol hydrochloride 80 MG 24 HR Extended Release Oral CapsuleSY414c4b69-38a1-4220-bec8-204c9a624b856
856569propranolol HCl 80 MG 24HR Extended Release Oral CapsulePSN87967c3a-4a6e-45c8-ae3d-1e1dbaa4ba101
85656924 HR propranolol hydrochloride 80 MG Extended Release Oral CapsuleSCD87967c3a-4a6e-45c8-ae3d-1e1dbaa4ba101
856569propranolol hydrochloride 80 MG 24 HR Extended Release Oral CapsuleSY87967c3a-4a6e-45c8-ae3d-1e1dbaa4ba101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0527-4117-3700527411737100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0527-4117-37) 2020-01-060000-00-00NoNoCurrent
0527-4117-4100527411741500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0527-4117-41) 2020-01-060000-00-00NoNoCurrent