FDA.reportPublic FDA data

propranolol hydrochloride

Product NDC
71335-0234
11-digit product format
713350234
Labeler code
71335
Product ID
71335-0234_f62cd9d6-1e68-4b0c-a9ad-478e610bee8a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
propranolol hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA078703
Marketing category
ANDA
Marketing start
2013-03-11
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
71335-0234-1propranolol hydrochloride30 in 1 BOTTLECAPSULE, EXTENDED RELEASE309
71335-0234-2propranolol hydrochloride18 in 1 BOTTLECAPSULE, EXTENDED RELEASE189
71335-0234-3propranolol hydrochloride90 in 1 BOTTLECAPSULE, EXTENDED RELEASE909
71335-0234-4propranolol hydrochloride28 in 1 BOTTLECAPSULE, EXTENDED RELEASE289
71335-0234-5propranolol hydrochloride60 in 1 BOTTLECAPSULE, EXTENDED RELEASE609
71335-0234-6propranolol hydrochloride10 in 1 BOTTLECAPSULE, EXTENDED RELEASE109
71335-0234-7propranolol hydrochloride100 in 1 BOTTLECAPSULE, EXTENDED RELEASE1009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0234-1EA - Each71335-0234f2a4be04-957b-48cd-ba92-548181202df012022-02-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0234PROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [BRYANT RANCH PREPACK]8Current NDC, Legacy NDC, 7 package rows20240509_82a4d30b-5018-453d-a8ab-fef2e3266f69.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856535propranolol HCl 60 MG 24HR Extended Release Oral CapsulePSN82a4d30b-5018-453d-a8ab-fef2e3266f699
85653524 HR propranolol hydrochloride 60 MG Extended Release Oral CapsuleSCD82a4d30b-5018-453d-a8ab-fef2e3266f699
856535propranolol hydrochloride 60 MG 24 HR Extended Release Oral CapsuleSY82a4d30b-5018-453d-a8ab-fef2e3266f699

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-0234-17133502340130 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-0234-1) 2018-02-160000-00-00NoNoCurrent
71335-0234-27133502340218 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-0234-2) 2021-12-270000-00-00NoNoCurrent
71335-0234-37133502340390 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-0234-3) 2021-12-270000-00-00NoNoCurrent
71335-0234-47133502340428 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-0234-4) 2021-12-270000-00-00NoNoCurrent
71335-0234-57133502340560 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-0234-5) 2021-12-270000-00-00NoNoCurrent
71335-0234-67133502340610 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-0234-6) 2021-12-270000-00-00NoNoCurrent
71335-0234-771335023407100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-0234-7) 2021-12-27NoNoCurrent