FDA.reportPublic FDA data

Propranolol Hydrochloride

Product NDC
71335-1765
11-digit product format
713351765
Labeler code
71335
Product ID
71335-1765_ebc207a3-62f9-4f11-a790-8caf04a30fea
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
propranolol hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
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
Rxcui856535

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
71335-1765-1Propranolol Hydrochloride30 in 1 BOTTLECAPSULE, EXTENDED RELEASE30104
71335-1765-2Propranolol Hydrochloride18 in 1 BOTTLECAPSULE, EXTENDED RELEASE18104
71335-1765-3Propranolol Hydrochloride90 in 1 BOTTLECAPSULE, EXTENDED RELEASE90104
71335-1765-4Propranolol Hydrochloride28 in 1 BOTTLECAPSULE, EXTENDED RELEASE28104
71335-1765-5Propranolol Hydrochloride60 in 1 BOTTLECAPSULE, EXTENDED RELEASE60104
71335-1765-6Propranolol Hydrochloride10 in 1 BOTTLECAPSULE, EXTENDED RELEASE10104
71335-1765-7Propranolol Hydrochloride100 in 1 BOTTLECAPSULE, EXTENDED RELEASE100104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1765PROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [BRYANT RANCH PREPACK]104Current NDC, Legacy NDC, 7 package rows20240915_ea98fedc-c440-487e-b144-35a8a389a446.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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1765-17133517650130 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-1765-1) 2021-01-080000-00-00NoNoCurrent
71335-1765-27133517650218 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-1765-2) 2024-09-060000-00-00NoNoCurrent
71335-1765-37133517650390 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-1765-3) 2024-09-060000-00-00NoNoCurrent
71335-1765-47133517650428 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-1765-4) 2024-09-060000-00-00NoNoCurrent
71335-1765-57133517650560 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-1765-5) 2024-09-06NoNoCurrent
71335-1765-67133517650610 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-1765-6) 2024-09-06NoNoCurrent
71335-1765-771335176507100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-1765-7) 2024-09-06NoNoCurrent