FDA.reportPublic FDA data

Propranolol Hydrochloride

Product NDC
60687-609
11-digit product format
606870609
Labeler code
60687
Product ID
60687-609_2205da94-02fb-4a72-e063-6294a90a396e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Propranolol Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
American Health Packaging
Application
ANDA070322
Marketing category
ANDA
Marketing start
2021-12-09
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
Rxcui856448, 856457, 856519

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
60687-609-01Propranolol Hydrochloride100 in 1 BOX, UNIT-DOSETABLET1003
60687-609-11Propranolol Hydrochloride1 in 1 BLISTER PACKTABLET13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-609PROPRANOLOL HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]3Current NDC, Legacy NDC, 2 package rows20240915_d027f39e-7648-44c8-a8dc-b26b4cdd81be.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856448propranolol HCl 10 MG Oral TabletPSNd027f39e-7648-44c8-a8dc-b26b4cdd81be3
856457propranolol HCl 20 MG Oral TabletPSNd027f39e-7648-44c8-a8dc-b26b4cdd81be3
856519propranolol HCl 40 MG Oral TabletPSNd027f39e-7648-44c8-a8dc-b26b4cdd81be3
856448propranolol hydrochloride 10 MG Oral TabletSCDd027f39e-7648-44c8-a8dc-b26b4cdd81be3
856457propranolol hydrochloride 20 MG Oral TabletSCDd027f39e-7648-44c8-a8dc-b26b4cdd81be3
856519propranolol hydrochloride 40 MG Oral TabletSCDd027f39e-7648-44c8-a8dc-b26b4cdd81be3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60687-609-0160687060901100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-609-01) / 1 TABLET in 1 BLISTER PACK (60687-609-11) 100 blister pack2021-12-090000-00-00NoNoCurrent
60687-609-11606870609111 in 1 BLISTER PACKHistorical