FDA.reportPublic FDA data

Propranolol HCL ER

Product NDC
61919-794
11-digit product format
619190794
Labeler code
61919
Product ID
61919-794_86e7dadc-9f78-2e0f-e053-2991aa0a5ec8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Propranolol HCL ER
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Direct Rx
Application
ANDA078703
Marketing category
ANDA
Marketing start
2019-04-19
Marketing end
0000-00-00
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
2020-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-794-302025-01-31C16284748780-11030e365-1ab9-111a-e063-dadaa90a10e2Propranolol hcl ER 60mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-794-30Propranolol HCL ER30 in 1 BOTTLECAPSULE, EXTENDED RELEASE302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-794-30EA - Each61919-7944c20586c-1508-4507-9517-49c9e28275e712019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-794PROPRANOLOL HCL ER CAPSULE, EXTENDED RELEASE PROPRANOLOL HYDROCHLORIDE ER CAPSULE, EXTENDED RELEASE PROPRANOLOL HCL ER CAPSULE, EXTENDED RELEASE [DIRECT RX]2Legacy NDC, 1 package rows20190420_5c370417-eff0-7280-e053-2a91aa0a1446.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856535propranolol HCl 60 MG 24HR Extended Release Oral CapsulePSN5c370417-eff0-7280-e053-2a91aa0a14462
856569propranolol HCl 80 MG 24HR Extended Release Oral CapsulePSN5c370417-eff0-7280-e053-2a91aa0a14462
85653524 HR propranolol hydrochloride 60 MG Extended Release Oral CapsuleSCD5c370417-eff0-7280-e053-2a91aa0a14462
85656924 HR propranolol hydrochloride 80 MG Extended Release Oral CapsuleSCD5c370417-eff0-7280-e053-2a91aa0a14462
856535propranolol hydrochloride 60 MG 24 HR Extended Release Oral CapsuleSY5c370417-eff0-7280-e053-2a91aa0a14462
856569propranolol hydrochloride 80 MG 24 HR Extended Release Oral CapsuleSY5c370417-eff0-7280-e053-2a91aa0a14462

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61919-794-306191907943030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (61919-794-30) 2019-04-190000-00-00NoNoCurrent