FDA.reportPublic FDA data

Propranolol Hydrochloride

Product NDC
69238-2081
11-digit product format
692382081
Labeler code
69238
Product ID
69238-2081_0f5168af-0988-4aa1-91dc-7c66758e18a8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Propranolol Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Amneal Pharmaceuticals NY LLC
Application
ANDA071976
Marketing category
ANDA
Marketing start
2021-06-03
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
69238-2081-1Propranolol Hydrochloride100 in 1 BOTTLETABLET1005
69238-2081-5Propranolol Hydrochloride500 in 1 BOTTLETABLET5005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69238-2081-1EA - Each69238-2081e21a49cc-2a4c-438b-aed7-abd67bc4226c12022-03-09
69238-2081-5EA - Each69238-2081f8a9e277-66a6-4a62-9cd7-b17bb30ef92c12022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69238-2081PROPRANOLOL HYDROCHLORIDE TABLET [AMNEAL PHARMACEUTICALS NY LLC]3Current NDC, Legacy NDC, 2 package rows20231231_14d0c95d-418f-40a8-bad3-e20c82424960.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856448propranolol HCl 10 MG Oral TabletPSN14d0c95d-418f-40a8-bad3-e20c824249605
856457propranolol HCl 20 MG Oral TabletPSN14d0c95d-418f-40a8-bad3-e20c824249605
856519propranolol HCl 40 MG Oral TabletPSN14d0c95d-418f-40a8-bad3-e20c824249605
856556propranolol HCl 60 MG Oral TabletPSN14d0c95d-418f-40a8-bad3-e20c824249605
856578propranolol HCl 80 MG Oral TabletPSN14d0c95d-418f-40a8-bad3-e20c824249605
856448propranolol hydrochloride 10 MG Oral TabletSCD14d0c95d-418f-40a8-bad3-e20c824249605
856457propranolol hydrochloride 20 MG Oral TabletSCD14d0c95d-418f-40a8-bad3-e20c824249605
856519propranolol hydrochloride 40 MG Oral TabletSCD14d0c95d-418f-40a8-bad3-e20c824249605
856556propranolol hydrochloride 60 MG Oral TabletSCD14d0c95d-418f-40a8-bad3-e20c824249605
856578propranolol hydrochloride 80 MG Oral TabletSCD14d0c95d-418f-40a8-bad3-e20c824249605

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69238-2081-169238208101100 TABLET in 1 BOTTLE (69238-2081-1) 100 tablet2021-06-030000-00-00NoNoCurrent
69238-2081-569238208105500 TABLET in 1 BOTTLE (69238-2081-5) 500 tablet2021-06-030000-00-00NoNoCurrent