FDA.reportPublic FDA data

Propranolol Hydrochloride

Product NDC
0591-5554
11-digit product format
005915554
Labeler code
0591
Product ID
0591-5554_c9eb1f85-2694-465e-9bca-17793419256c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Propranolol Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Actavis Pharma, Inc.
Application
ANDA070175
Marketing category
ANDA
Marketing start
1986-05-13
Marketing end
0000-00-00
Substance
PROPRANOLOL HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

Additional Listing Data#

Finished product
No
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PROPRANOLOL HYDROCHLORIDE10 mg/1

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0591-5554-01EA - Each0591-55544684268b-e2fa-49e1-87e4-473f522650ff12012-07-24
0591-5554-10EA - Each0591-5554a00275e7-f736-4128-b408-f3b6cf4864ab12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PROPRANOLOL HYDROCHLORIDEACTIVE INGREDIENTF8A3652H1VPROPRANOLOL HYDROCHLORIDE TABLET [WATSON LABORATORIES, INC.]7
PROPRANOLOLACTIVE MOIETY9Y8NXQ24VQPROPRANOLOL HYDROCHLORIDE TABLET [WATSON LABORATORIES, INC.]7
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKPROPRANOLOL HYDROCHLORIDE TABLET [WATSON LABORATORIES, INC.]7
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPROPRANOLOL HYDROCHLORIDE TABLET [WATSON LABORATORIES, INC.]7
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48PROPRANOLOL HYDROCHLORIDE TABLET [WATSON LABORATORIES, INC.]7
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GPROPRANOLOL HYDROCHLORIDE TABLET [WATSON LABORATORIES, INC.]7
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPROPRANOLOL HYDROCHLORIDE TABLET [WATSON LABORATORIES, INC.]7
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8PROPRANOLOL HYDROCHLORIDE TABLET [WATSON LABORATORIES, INC.]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PROPRANOLOL HYDROCHLORIDE TABLET [WATSON LABORATORIES, INC.]7
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PROPRANOLOL HYDROCHLORIDE TABLET [WATSON LABORATORIES, INC.]7
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APPROPRANOLOL HYDROCHLORIDE TABLET [WATSON LABORATORIES, INC.]7
PROPRANOLOL HYDROCHLORIDEACTIVE INGREDIENTF8A3652H1VPROPRANOLOL HYDROCHLORIDE TABLET [CARILION MATERIALS MANAGEMENT]4
PROPRANOLOLACTIVE MOIETY9Y8NXQ24VQPROPRANOLOL HYDROCHLORIDE TABLET [CARILION MATERIALS MANAGEMENT]4
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKPROPRANOLOL HYDROCHLORIDE TABLET [CARILION MATERIALS MANAGEMENT]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPROPRANOLOL HYDROCHLORIDE TABLET [CARILION MATERIALS MANAGEMENT]4
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48PROPRANOLOL HYDROCHLORIDE TABLET [CARILION MATERIALS MANAGEMENT]4
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GPROPRANOLOL HYDROCHLORIDE TABLET [CARILION MATERIALS MANAGEMENT]4
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8PROPRANOLOL HYDROCHLORIDE TABLET [CARILION MATERIALS MANAGEMENT]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PROPRANOLOL HYDROCHLORIDE TABLET [CARILION MATERIALS MANAGEMENT]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PROPRANOLOL HYDROCHLORIDE TABLET [CARILION MATERIALS MANAGEMENT]4
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APPROPRANOLOL HYDROCHLORIDE TABLET [CARILION MATERIALS MANAGEMENT]4
PROPRANOLOL HYDROCHLORIDEACTIVE INGREDIENTF8A3652H1VPROPRANOLOL (PROPRANOLOL HYDROCHLORIDE) TABLET [STAT RX USA LLC]1
PROPRANOLOLACTIVE MOIETY9Y8NXQ24VQPROPRANOLOL (PROPRANOLOL HYDROCHLORIDE) TABLET [STAT RX USA LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0591-5554PROPRANOLOL HYDROCHLORIDE TABLET [ACTAVIS PHARMA, INC.]14Legacy NDC20240517_ab9e5678-db53-4354-998a-ed8bf1d33e90.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856448propranolol HCl 10 MG Oral TabletPSN3b21bec3-3b6a-4d6d-adf7-11dedbd37abe4
856448propranolol hydrochloride 10 MG Oral TabletSCD3b21bec3-3b6a-4d6d-adf7-11dedbd37abe4
856448propranolol HCl 10 MG Oral TabletPSN60c0a5e1-9298-4a00-92b7-3a1ef7ad17cc1
856448propranolol hydrochloride 10 MG Oral TabletSCD60c0a5e1-9298-4a00-92b7-3a1ef7ad17cc1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0591-5554-0100591555401100 TABLET in 1 BOTTLE, PLASTIC (0591-5554-01) 100 tablet1986-05-130000-00-00NoNoCurrent
0591-5554-10005915554101000 TABLET in 1 BOTTLE, PLASTIC (0591-5554-10) 1000 tablet1986-05-130000-00-00NoNoCurrent