FDA.reportPublic FDA data

Propranolol Hydrochloride

Product NDC
0603-5483
11-digit product format
006035483
Labeler code
0603
Product ID
0603-5483_2d7e19e5-6f01-4657-a201-829ea5a74f84
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
propranolol hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Endo USA, Inc.
Application
ANDA070221
Marketing category
ANDA
Marketing start
2010-06-21
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, 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
0603-5483-02Propranolol Hydrochloride90 in 1 BOTTLETABLET9018
0603-5483-21Propranolol Hydrochloride100 in 1 BOTTLETABLET10018
0603-5483-32Propranolol Hydrochloride1000 in 1 BOTTLETABLET100018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0603-5483-02EA - Each0603-5483048bf07f-1a68-4001-aad9-8a8d329a551d12012-07-24
0603-5483-21EA - Each0603-5483de4cab18-742b-4e76-87c1-23e60d85cede12012-07-24
0603-5483-32EA - Each0603-5483f76838b4-70a1-4abf-9af1-ba17c7ad358812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PROPRANOLOL HYDROCHLORIDEACTIVE INGREDIENTF8A3652H1VPROPRANOLOL HYDROCHLORIDE TABLET [QUALITEST PHARMACEUTICALS]7
PROPRANOLOLACTIVE MOIETY9Y8NXQ24VQPROPRANOLOL HYDROCHLORIDE TABLET [QUALITEST PHARMACEUTICALS]7
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKPROPRANOLOL HYDROCHLORIDE TABLET [QUALITEST PHARMACEUTICALS]7
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPROPRANOLOL HYDROCHLORIDE TABLET [QUALITEST PHARMACEUTICALS]7
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48PROPRANOLOL HYDROCHLORIDE TABLET [QUALITEST PHARMACEUTICALS]7
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GPROPRANOLOL HYDROCHLORIDE TABLET [QUALITEST PHARMACEUTICALS]7
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPROPRANOLOL HYDROCHLORIDE TABLET [QUALITEST PHARMACEUTICALS]7
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKPROPRANOLOL HYDROCHLORIDE TABLET [QUALITEST PHARMACEUTICALS]7
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAPROPRANOLOL HYDROCHLORIDE TABLET [QUALITEST PHARMACEUTICALS]7
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8PROPRANOLOL HYDROCHLORIDE TABLET [QUALITEST PHARMACEUTICALS]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PROPRANOLOL HYDROCHLORIDE TABLET [QUALITEST PHARMACEUTICALS]7
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PROPRANOLOL HYDROCHLORIDE TABLET [QUALITEST PHARMACEUTICALS]7
PROPRANOLOL HYDROCHLORIDEACTIVE INGREDIENTF8A3652H1VPROPRANOLOL HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]3
PROPRANOLOLACTIVE MOIETY9Y8NXQ24VQPROPRANOLOL HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]3
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKPROPRANOLOL HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPROPRANOLOL HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]3
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PROPRANOLOL HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48PROPRANOLOL HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GPROPRANOLOL HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPROPRANOLOL HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]3
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8PROPRANOLOL HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PROPRANOLOL HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]3
PROPRANOLOL HYDROCHLORIDEACTIVE INGREDIENTF8A3652H1VPROPRANOLOL HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
PROPRANOLOLACTIVE MOIETY9Y8NXQ24VQPROPRANOLOL HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKPROPRANOLOL HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPROPRANOLOL HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48PROPRANOLOL HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GPROPRANOLOL HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPROPRANOLOL HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKPROPRANOLOL HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PROPRANOLOL HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PROPRANOLOL HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0603-5483PROPRANOLOL HYDROCHLORIDE TABLET [ENDO USA, INC.]18Current NDC, Legacy NDC, 3 package rows20240926_0d74bb04-8227-4afa-b523-ce1556150e07.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856457propranolol HCl 20 MG Oral TabletPSN062a1734-00d1-4871-8e7e-450b0ff5864c104
856457propranolol hydrochloride 20 MG Oral TabletSCD062a1734-00d1-4871-8e7e-450b0ff5864c104
856457propranolol HCl 20 MG Oral TabletPSN8b3f61f9-2efc-40c1-9c80-11aa145b3484103
856457propranolol hydrochloride 20 MG Oral TabletSCD8b3f61f9-2efc-40c1-9c80-11aa145b3484103
856457propranolol HCl 20 MG Oral TabletPSN89331052-2648-46c6-8d4c-7934ab1ee683101
856457propranolol hydrochloride 20 MG Oral TabletSCD89331052-2648-46c6-8d4c-7934ab1ee683101
856448propranolol HCl 10 MG Oral TabletPSN360de855-b8be-409f-9ca6-d0a0368af17422
856457propranolol HCl 20 MG Oral TabletPSN360de855-b8be-409f-9ca6-d0a0368af17422
856519propranolol HCl 40 MG Oral TabletPSN360de855-b8be-409f-9ca6-d0a0368af17422
856578propranolol HCl 80 MG Oral TabletPSN360de855-b8be-409f-9ca6-d0a0368af17422
856448propranolol hydrochloride 10 MG Oral TabletSCD360de855-b8be-409f-9ca6-d0a0368af17422
856457propranolol hydrochloride 20 MG Oral TabletSCD360de855-b8be-409f-9ca6-d0a0368af17422
856519propranolol hydrochloride 40 MG Oral TabletSCD360de855-b8be-409f-9ca6-d0a0368af17422
856578propranolol hydrochloride 80 MG Oral TabletSCD360de855-b8be-409f-9ca6-d0a0368af17422
856457propranolol HCl 20 MG Oral TabletPSNed10dd67-5987-4191-b2d3-9dcf40340caa21
856457propranolol hydrochloride 20 MG Oral TabletSCDed10dd67-5987-4191-b2d3-9dcf40340caa21
856448propranolol HCl 10 MG Oral TabletPSN0d74bb04-8227-4afa-b523-ce1556150e0718
856457propranolol HCl 20 MG Oral TabletPSN0d74bb04-8227-4afa-b523-ce1556150e0718
856519propranolol HCl 40 MG Oral TabletPSN0d74bb04-8227-4afa-b523-ce1556150e0718
856556propranolol HCl 60 MG Oral TabletPSN0d74bb04-8227-4afa-b523-ce1556150e0718
856578propranolol HCl 80 MG Oral TabletPSN0d74bb04-8227-4afa-b523-ce1556150e0718
856448propranolol hydrochloride 10 MG Oral TabletSCD0d74bb04-8227-4afa-b523-ce1556150e0718
856457propranolol hydrochloride 20 MG Oral TabletSCD0d74bb04-8227-4afa-b523-ce1556150e0718
856519propranolol hydrochloride 40 MG Oral TabletSCD0d74bb04-8227-4afa-b523-ce1556150e0718
856556propranolol hydrochloride 60 MG Oral TabletSCD0d74bb04-8227-4afa-b523-ce1556150e0718
856578propranolol hydrochloride 80 MG Oral TabletSCD0d74bb04-8227-4afa-b523-ce1556150e0718
856448propranolol HCl 10 MG Oral TabletPSN1a821300-3d6c-4990-ae6d-771d549adddf17
856457propranolol HCl 20 MG Oral TabletPSN1a821300-3d6c-4990-ae6d-771d549adddf17
856448propranolol hydrochloride 10 MG Oral TabletSCD1a821300-3d6c-4990-ae6d-771d549adddf17
856457propranolol hydrochloride 20 MG Oral TabletSCD1a821300-3d6c-4990-ae6d-771d549adddf17
856457propranolol HCl 20 MG Oral TabletPSNf2b8b894-d887-c4ee-e053-2995a90a0c0b4
856457propranolol hydrochloride 20 MG Oral TabletSCDf2b8b894-d887-c4ee-e053-2995a90a0c0b4
856448propranolol HCl 10 MG Oral TabletPSN813dbecc-e5d4-4713-950f-c81d821205203
856457propranolol HCl 20 MG Oral TabletPSN813dbecc-e5d4-4713-950f-c81d821205203
856448propranolol hydrochloride 10 MG Oral TabletSCD813dbecc-e5d4-4713-950f-c81d821205203
856457propranolol hydrochloride 20 MG Oral TabletSCD813dbecc-e5d4-4713-950f-c81d821205203
856457propranolol HCl 20 MG Oral TabletPSN4faa1082-85f1-414a-e054-00144ff8d46c2
856457propranolol HCl 20 MG Oral TabletPSNfbb783db-02c2-4f18-9866-89ec38c19bea2
856457propranolol hydrochloride 20 MG Oral TabletSCD4faa1082-85f1-414a-e054-00144ff8d46c2
856457propranolol hydrochloride 20 MG Oral TabletSCDfbb783db-02c2-4f18-9866-89ec38c19bea2
856457propranolol HCl 20 MG Oral TabletPSNa5daa747-26e8-4065-9e8c-fc491c45eb591
856519propranolol HCl 40 MG Oral TabletPSNa5daa747-26e8-4065-9e8c-fc491c45eb591
856457propranolol hydrochloride 20 MG Oral TabletSCDa5daa747-26e8-4065-9e8c-fc491c45eb591
856519propranolol hydrochloride 40 MG Oral TabletSCDa5daa747-26e8-4065-9e8c-fc491c45eb591

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0603-5483-020060354830290 in 1 BOTTLEHistorical
0603-5483-2100603548321100 TABLET in 1 BOTTLE (0603-5483-21) 100 tablet2010-06-210000-00-00NoNoCurrent
0603-5483-32006035483321000 TABLET in 1 BOTTLE (0603-5483-32) 1000 tablet2010-06-210000-00-00NoNoCurrent