FDA.reportPublic FDA data

Propranolol Hydrochloride

Product NDC
68788-8620
11-digit product format
687888620
Labeler code
68788
Product ID
68788-8620_8c765672-66b8-44bb-8252-792d539e057b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Propranolol Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA070322
Marketing category
ANDA
Marketing start
2024-04-02
Substance
PROPRANOLOL HYDROCHLORIDE
Active strength
40 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 HYDROCHLORIDE40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF8A3652H1V
Rxcui856519

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
68788-8620-1Propranolol Hydrochloride100 in 1 BOTTLETABLET1002
68788-8620-3Propranolol Hydrochloride30 in 1 BOTTLETABLET302
68788-8620-6Propranolol Hydrochloride60 in 1 BOTTLETABLET602
68788-8620-9Propranolol Hydrochloride90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8620-1EA - Each68788-8620befb8570-2a28-4e95-b17d-f1d795a9e78012024-06-10
68788-8620-3EA - Each68788-8620aace3c37-82c5-4d20-b3f8-e145e9c2a5d112024-06-10
68788-8620-6EA - Each68788-8620012ce9a6-1e2a-4d4a-953b-dbc80b28064312024-06-10
68788-8620-9EA - Each68788-8620ed88185b-8758-41bb-b857-753fe46b787f12024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8620PROPRANOLOL HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS INC.]1Current NDC, 4 package rows20240413_52da1afc-7f1c-4893-ab84-8479dd939951.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856519propranolol HCl 40 MG Oral TabletPSN52da1afc-7f1c-4893-ab84-8479dd9399512
856519propranolol hydrochloride 40 MG Oral TabletSCD52da1afc-7f1c-4893-ab84-8479dd9399512

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8620-168788862001100 TABLET in 1 BOTTLE (68788-8620-1) 100 tablet2024-04-02NoNoHistorical
68788-8620-36878886200330 TABLET in 1 BOTTLE (68788-8620-3) 30 tablet2024-04-02NoNoHistorical
68788-8620-66878886200660 TABLET in 1 BOTTLE (68788-8620-6) 60 tablet2024-04-02NoNoHistorical
68788-8620-96878886200990 TABLET in 1 BOTTLE (68788-8620-9) 90 tablet2024-04-02NoNoHistorical