FDA.reportPublic FDA data

Propranolol Hydrochloride

Product NDC
0904-7468
11-digit product format
009047468
Labeler code
0904
Product ID
0904-7468_b9cee427-7372-4b05-9d11-b6d1371f8081
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Propranolol Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA071972
Marketing category
ANDA
Marketing start
2024-09-20
Substance
PROPRANOLOL HYDROCHLORIDE
Active strength
20 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 HYDROCHLORIDE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF8A3652H1V
Rxcui856448, 856457

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
0904-7468-06Propranolol Hydrochloride1 in 1 BLISTER PACKTABLET13
0904-7468-06Propranolol Hydrochloride50 in 1 CARTONTABLET503
0904-7468-61Propranolol Hydrochloride100 in 1 CARTONTABLET1003
0904-7468-61Propranolol Hydrochloride1 in 1 BLISTER PACKTABLET13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-7468-06EA - Each0904-746876ed634f-89ca-46a9-8e1e-9668e2a867af12024-12-10
0904-7468-61EA - Each0904-7468be2e5d85-ca0c-41b7-953a-4fddaf51160f12024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-7468PROPRANOLOL HYDROCHLORIDE TABLET [MAJOR PHARMACEUTICALS]1Current NDC, 4 package rows20240925_e7218c9b-b9b8-4cf0-a2c7-c759ad3a65ba.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856448propranolol HCl 10 MG Oral TabletPSNe7218c9b-b9b8-4cf0-a2c7-c759ad3a65ba3
856457propranolol HCl 20 MG Oral TabletPSNe7218c9b-b9b8-4cf0-a2c7-c759ad3a65ba3
856448propranolol hydrochloride 10 MG Oral TabletSCDe7218c9b-b9b8-4cf0-a2c7-c759ad3a65ba3
856457propranolol hydrochloride 20 MG Oral TabletSCDe7218c9b-b9b8-4cf0-a2c7-c759ad3a65ba3
856457propranolol HCl 20 MG Oral TabletPSN74dc9949-010c-4f2c-9aef-63ab466ba6571
856457propranolol hydrochloride 20 MG Oral TabletSCD74dc9949-010c-4f2c-9aef-63ab466ba6571

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0904-7468-060090474680650 BLISTER PACK in 1 CARTON (0904-7468-06) / 1 TABLET in 1 BLISTER PACK50 blister pack2024-09-20NoNoHistorical
0904-7468-6100904746861100 BLISTER PACK in 1 CARTON (0904-7468-61) / 1 TABLET in 1 BLISTER PACK100 blister pack2024-09-20NoNoHistorical