FDA.reportPublic FDA data

Propranolol Hydrochloride

Product NDC
0378-0185
11-digit product format
003780185
Labeler code
0378
Product ID
0378-0185_4b043e3b-c0dc-4e37-a2fb-86c51a99c054
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
propranolol hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA070213
Marketing category
ANDA
Marketing start
1985-11-19
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Propranolol Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PROPRANOLOL HYDROCHLORIDE80 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF8A3652H1V
Rxcui856448, 856457, 856519, 856556, 856578

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
0378-0185-01Propranolol Hydrochloride100 in 1 BOTTLE, PLASTICTABLET10013
0378-0185-05Propranolol Hydrochloride500 in 1 BOTTLE, PLASTICTABLET50013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-0185-01EA - Each0378-0185029da63a-48c5-48df-b17a-0758fb33345912012-07-24
0378-0185-05EA - Each0378-0185dd226a1f-3f22-4b21-a066-fb5728587c2512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PROPRANOLOL HYDROCHLORIDEACTIVE INGREDIENTF8A3652H1VPROPRANOLOL HYDROCHLORIDE TABLET [MYLAN PHARMACEUTICALS INC.]5
PROPRANOLOLACTIVE MOIETY9Y8NXQ24VQPROPRANOLOL HYDROCHLORIDE TABLET [MYLAN PHARMACEUTICALS INC.]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPROPRANOLOL HYDROCHLORIDE TABLET [MYLAN PHARMACEUTICALS INC.]5
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48PROPRANOLOL HYDROCHLORIDE TABLET [MYLAN PHARMACEUTICALS INC.]5
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GPROPRANOLOL HYDROCHLORIDE TABLET [MYLAN PHARMACEUTICALS INC.]5
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPROPRANOLOL HYDROCHLORIDE TABLET [MYLAN PHARMACEUTICALS INC.]5
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAPROPRANOLOL HYDROCHLORIDE TABLET [MYLAN PHARMACEUTICALS INC.]5
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8PROPRANOLOL HYDROCHLORIDE TABLET [MYLAN PHARMACEUTICALS INC.]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PROPRANOLOL HYDROCHLORIDE TABLET [MYLAN PHARMACEUTICALS INC.]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PROPRANOLOL HYDROCHLORIDE TABLET [MYLAN PHARMACEUTICALS INC.]5
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JPROPRANOLOL HYDROCHLORIDE TABLET [MYLAN PHARMACEUTICALS INC.]5
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPROPRANOLOL HYDROCHLORIDE TABLET [MYLAN PHARMACEUTICALS INC.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-0185PROPRANOLOL HYDROCHLORIDE TABLET [MYLAN PHARMACEUTICALS INC.]11Current NDC, Legacy NDC, 2 package rows20240420_b94dcec7-7633-4a33-9cea-48161adeaf93.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856448propranolol HCl 10 MG Oral TabletPSNb94dcec7-7633-4a33-9cea-48161adeaf9313
856457propranolol HCl 20 MG Oral TabletPSNb94dcec7-7633-4a33-9cea-48161adeaf9313
856519propranolol HCl 40 MG Oral TabletPSNb94dcec7-7633-4a33-9cea-48161adeaf9313
856556propranolol HCl 60 MG Oral TabletPSNb94dcec7-7633-4a33-9cea-48161adeaf9313
856578propranolol HCl 80 MG Oral TabletPSNb94dcec7-7633-4a33-9cea-48161adeaf9313
856448propranolol hydrochloride 10 MG Oral TabletSCDb94dcec7-7633-4a33-9cea-48161adeaf9313
856457propranolol hydrochloride 20 MG Oral TabletSCDb94dcec7-7633-4a33-9cea-48161adeaf9313
856519propranolol hydrochloride 40 MG Oral TabletSCDb94dcec7-7633-4a33-9cea-48161adeaf9313
856556propranolol hydrochloride 60 MG Oral TabletSCDb94dcec7-7633-4a33-9cea-48161adeaf9313
856578propranolol hydrochloride 80 MG Oral TabletSCDb94dcec7-7633-4a33-9cea-48161adeaf9313
856448propranolol HCl 10 MG Oral TabletPSN8cbac6dc-ef1d-6662-e053-2995a90af13f7
856457propranolol HCl 20 MG Oral TabletPSN8cbac6dc-ef1d-6662-e053-2995a90af13f7
856519propranolol HCl 40 MG Oral TabletPSN8cbac6dc-ef1d-6662-e053-2995a90af13f7
856556propranolol HCl 60 MG Oral TabletPSN8cbac6dc-ef1d-6662-e053-2995a90af13f7
856578propranolol HCl 80 MG Oral TabletPSN8cbac6dc-ef1d-6662-e053-2995a90af13f7
856448propranolol hydrochloride 10 MG Oral TabletSCD8cbac6dc-ef1d-6662-e053-2995a90af13f7
856457propranolol hydrochloride 20 MG Oral TabletSCD8cbac6dc-ef1d-6662-e053-2995a90af13f7
856519propranolol hydrochloride 40 MG Oral TabletSCD8cbac6dc-ef1d-6662-e053-2995a90af13f7
856556propranolol hydrochloride 60 MG Oral TabletSCD8cbac6dc-ef1d-6662-e053-2995a90af13f7
856578propranolol hydrochloride 80 MG Oral TabletSCD8cbac6dc-ef1d-6662-e053-2995a90af13f7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0378-0185-0100378018501100 TABLET in 1 BOTTLE, PLASTIC (0378-0185-01) 100 tablet1985-11-190000-00-00NoNoCurrent
0378-0185-0500378018505500 TABLET in 1 BOTTLE, PLASTIC (0378-0185-05) 500 tablet1985-11-190000-00-00NoNoCurrent