FDA.reportPublic FDA data

Propranolol Hydrochloride

Product NDC
60687-226
11-digit product format
606870226
Labeler code
60687
Product ID
60687-226_3f2c1ac2-1bb2-3613-e063-6394a90a211f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Propranolol Hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
American Health Packaging
Application
ANDA078703
Marketing category
ANDA
Marketing start
2017-07-14
Substance
PROPRANOLOL HYDROCHLORIDE
Active strength
80 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 HYDROCHLORIDE80 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF8A3652H1V
Rxcui856535, 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
60687-226-01Propranolol Hydrochloride100 in 1 BOX, UNIT-DOSECAPSULE, EXTENDED RELEASE1007
60687-226-11Propranolol Hydrochloride1 in 1 BLISTER PACKCAPSULE, EXTENDED RELEASE17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-226-01EA - Each60687-22655f49008-6ff2-412c-b9b1-a76392176a4b12017-08-11
60687-226-11EA - Each60687-226a4c44dc7-97c8-4746-9bc6-6762f2a8acac12017-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-226PROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]6Current NDC, Legacy NDC, 2 package rows20241115_015b5e4f-3228-4259-b419-e0e49694a058.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856535propranolol HCl 60 MG 24HR Extended Release Oral CapsulePSN015b5e4f-3228-4259-b419-e0e49694a0587
856569propranolol HCl 80 MG 24HR Extended Release Oral CapsulePSN015b5e4f-3228-4259-b419-e0e49694a0587
85653524 HR propranolol hydrochloride 60 MG Extended Release Oral CapsuleSCD015b5e4f-3228-4259-b419-e0e49694a0587
85656924 HR propranolol hydrochloride 80 MG Extended Release Oral CapsuleSCD015b5e4f-3228-4259-b419-e0e49694a0587
856535propranolol hydrochloride 60 MG 24 HR Extended Release Oral CapsuleSY015b5e4f-3228-4259-b419-e0e49694a0587
856569propranolol hydrochloride 80 MG 24 HR Extended Release Oral CapsuleSY015b5e4f-3228-4259-b419-e0e49694a0587

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60687-226-0160687022601100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-226-01) / 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (60687-226-11) 100 blister pack2017-07-140000-00-00NoNoCurrent
60687-226-11606870226111 in 1 BLISTER PACKHistorical