FDA.reportPublic FDA data

Propranolol Hydrochloride

Product NDC
71205-760
11-digit product format
712050760
Labeler code
71205
Product ID
71205-760_968353ed-eb79-4f96-9569-3efb220fc388
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Propranolol Hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA078494
Marketing category
ANDA
Marketing start
2007-08-10
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
71205-760-30Propranolol Hydrochloride30 in 1 BOTTLECAPSULE, EXTENDED RELEASE301
71205-760-60Propranolol Hydrochloride60 in 1 BOTTLECAPSULE, EXTENDED RELEASE601
71205-760-90Propranolol Hydrochloride90 in 1 BOTTLECAPSULE, EXTENDED RELEASE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-760-30EA - Each71205-760c7d2515e-b7fc-4cce-86b1-476adbcce33212023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-760PROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [PROFICIENT RX LP]1Current NDC, 3 package rows20230211_968353ed-eb79-4f96-9569-3efb220fc388.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856535propranolol HCl 60 MG 24HR Extended Release Oral CapsulePSN968353ed-eb79-4f96-9569-3efb220fc3881
85653524 HR propranolol hydrochloride 60 MG Extended Release Oral CapsuleSCD968353ed-eb79-4f96-9569-3efb220fc3881
856535propranolol hydrochloride 60 MG 24 HR Extended Release Oral CapsuleSY968353ed-eb79-4f96-9569-3efb220fc3881

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71205-760-307120507603030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71205-760-30) 2023-02-09NoNoCurrent
71205-760-607120507606060 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71205-760-60) 2023-02-09NoNoCurrent
71205-760-907120507609090 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71205-760-90) 2023-02-09NoNoCurrent