FDA.reportPublic FDA data

Propranolol Hydrochloride

Product NDC
0228-2778
11-digit product format
002282778
Labeler code
0228
Product ID
0228-2778_1f70f68b-1314-4c20-872e-993e0f33fb43
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Propranolol Hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Actavis Pharma, Inc.
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
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
0228-2778-11Propranolol Hydrochloride100 in 1 BOTTLECAPSULE, EXTENDED RELEASE10011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0228-2778-11EA - Each0228-27782faa4579-07e6-4078-b2b3-c1a8ca76dc5012012-07-24
0228-2778-50EA - Each0228-277882cfc71c-2ccb-4066-8f73-4ffb9dff61e812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PROPRANOLOL HYDROCHLORIDEACTIVE INGREDIENTF8A3652H1VPROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [ACTAVIS ELIZABETH LLC]4
PROPRANOLOLACTIVE MOIETY9Y8NXQ24VQPROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [ACTAVIS ELIZABETH LLC]4
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GPROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [ACTAVIS ELIZABETH LLC]4
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4BPROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [ACTAVIS ELIZABETH LLC]4
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [ACTAVIS ELIZABETH LLC]4
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKPROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [ACTAVIS ELIZABETH LLC]4
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAPROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [ACTAVIS ELIZABETH LLC]4
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTPROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [ACTAVIS ELIZABETH LLC]4
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357PROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [ACTAVIS ELIZABETH LLC]4
GELATININACTIVE INGREDIENT2G86QN327LPROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [ACTAVIS ELIZABETH LLC]4
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PPROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [ACTAVIS ELIZABETH LLC]4
POVIDONE K29/32INACTIVE INGREDIENT390RMW2PEQPROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [ACTAVIS ELIZABETH LLC]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3PROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [ACTAVIS ELIZABETH LLC]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [ACTAVIS ELIZABETH LLC]4
SUCROSEINACTIVE INGREDIENTC151H8M554PROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [ACTAVIS ELIZABETH LLC]4
TALCINACTIVE INGREDIENT7SEV7J4R1UPROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [ACTAVIS ELIZABETH LLC]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [ACTAVIS ELIZABETH LLC]4
PROPRANOLOL HYDROCHLORIDEACTIVE INGREDIENTF8A3652H1VPROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
PROPRANOLOLACTIVE MOIETY9Y8NXQ24VQPROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GPROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4BPROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKPROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAPROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTPROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357PROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
GELATININACTIVE INGREDIENT2G86QN327LPROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PPROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
POVIDONE K29/32INACTIVE INGREDIENT390RMW2PEQPROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3PROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
SUCROSEINACTIVE INGREDIENTC151H8M554PROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
TALCINACTIVE INGREDIENT7SEV7J4R1UPROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0228-2778PROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]10Current NDC, Legacy NDC, 1 package rows20240523_a4edba76-29b8-41fb-bf0b-d4633abba003.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856460propranolol HCl 120 MG 24HR Extended Release Oral CapsulePSNa4edba76-29b8-41fb-bf0b-d4633abba00311
856481propranolol HCl 160 MG 24HR Extended Release Oral CapsulePSNa4edba76-29b8-41fb-bf0b-d4633abba00311
856535propranolol HCl 60 MG 24HR Extended Release Oral CapsulePSNa4edba76-29b8-41fb-bf0b-d4633abba00311
856569propranolol HCl 80 MG 24HR Extended Release Oral CapsulePSNa4edba76-29b8-41fb-bf0b-d4633abba00311
85646024 HR propranolol hydrochloride 120 MG Extended Release Oral CapsuleSCDa4edba76-29b8-41fb-bf0b-d4633abba00311
85648124 HR propranolol hydrochloride 160 MG Extended Release Oral CapsuleSCDa4edba76-29b8-41fb-bf0b-d4633abba00311
85653524 HR propranolol hydrochloride 60 MG Extended Release Oral CapsuleSCDa4edba76-29b8-41fb-bf0b-d4633abba00311
85656924 HR propranolol hydrochloride 80 MG Extended Release Oral CapsuleSCDa4edba76-29b8-41fb-bf0b-d4633abba00311
856460propranolol hydrochloride 120 MG 24 HR Extended Release Oral CapsuleSYa4edba76-29b8-41fb-bf0b-d4633abba00311
856481propranolol hydrochloride 160 MG 24 HR Extended Release Oral CapsuleSYa4edba76-29b8-41fb-bf0b-d4633abba00311
856535propranolol hydrochloride 60 MG 24 HR Extended Release Oral CapsuleSYa4edba76-29b8-41fb-bf0b-d4633abba00311
856569propranolol hydrochloride 80 MG 24 HR Extended Release Oral CapsuleSYa4edba76-29b8-41fb-bf0b-d4633abba00311
856535propranolol HCl 60 MG 24HR Extended Release Oral CapsulePSN37438047-b456-4e85-a7cc-3eb688908cfe4
85653524 HR propranolol hydrochloride 60 MG Extended Release Oral CapsuleSCD37438047-b456-4e85-a7cc-3eb688908cfe4
856535propranolol hydrochloride 60 MG 24 HR Extended Release Oral CapsuleSY37438047-b456-4e85-a7cc-3eb688908cfe4
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 startMarketing endSampleExclude flagStatus
0228-2778-1100228277811100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0228-2778-11) 2007-08-100000-00-00NoNoCurrent