FDA.reportPublic FDA data

Propranolol Hydrochloride

Product NDC
69238-2078
11-digit product format
692382078
Labeler code
69238
Product ID
69238-2078_0f5168af-0988-4aa1-91dc-7c66758e18a8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Propranolol Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Amneal Pharmaceuticals NY LLC
Application
ANDA071972
Marketing category
ANDA
Marketing start
2021-06-03
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
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 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
69238-2078-1Propranolol Hydrochloride100 in 1 BOTTLETABLET1005
69238-2078-7Propranolol Hydrochloride1000 in 1 BOTTLETABLET10005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69238-2078-1EA - Each69238-2078b1fa762c-34bf-4ab6-b7af-d154452e856112022-02-07
69238-2078-7EA - Each69238-2078477dbf21-79f1-48d8-8323-2591d8635a1812021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69238-2078PROPRANOLOL 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
856457propranolol HCl 20 MG Oral TabletPSN1d79ba59-6346-46c0-8e63-470e2069238e102
856457propranolol hydrochloride 20 MG Oral TabletSCD1d79ba59-6346-46c0-8e63-470e2069238e102
856457propranolol HCl 20 MG Oral TabletPSNa3bd3ef9-539d-450e-900b-95be0e46095b9
856457propranolol hydrochloride 20 MG Oral TabletSCDa3bd3ef9-539d-450e-900b-95be0e46095b9
856457propranolol HCl 20 MG Oral TabletPSN49d09308-74b0-4f9a-9c03-37234b5ee3a37
856457propranolol hydrochloride 20 MG Oral TabletSCD49d09308-74b0-4f9a-9c03-37234b5ee3a37
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
856448propranolol HCl 10 MG Oral TabletPSNe7218c9b-b9b8-4cf0-a2c7-c759ad3a65ba3
856457propranolol HCl 20 MG Oral TabletPSN03afbc5a-a9dc-e823-e063-6394a90a0cb23
856457propranolol HCl 20 MG Oral TabletPSNe7218c9b-b9b8-4cf0-a2c7-c759ad3a65ba3
856457propranolol HCl 20 MG Oral TabletPSN325dda2c-ecd9-4368-8779-7ff505b2b1383
856448propranolol hydrochloride 10 MG Oral TabletSCDe7218c9b-b9b8-4cf0-a2c7-c759ad3a65ba3
856457propranolol hydrochloride 20 MG Oral TabletSCD03afbc5a-a9dc-e823-e063-6394a90a0cb23
856457propranolol hydrochloride 20 MG Oral TabletSCD325dda2c-ecd9-4368-8779-7ff505b2b1383
856457propranolol hydrochloride 20 MG Oral TabletSCDe7218c9b-b9b8-4cf0-a2c7-c759ad3a65ba3
856448propranolol HCl 10 MG Oral TabletPSN039b415b-094a-da37-e063-6294a90a52d72
856457propranolol HCl 20 MG Oral TabletPSN1791ef4d-b609-41c8-b4ef-15bff752ddd72
856457propranolol HCl 20 MG Oral TabletPSN4d24ea79-ba56-44f4-b1a6-e27235176c4a2
856457propranolol HCl 20 MG Oral TabletPSN039b415b-094a-da37-e063-6294a90a52d72
856519propranolol HCl 40 MG Oral TabletPSN039b415b-094a-da37-e063-6294a90a52d72
856448propranolol hydrochloride 10 MG Oral TabletSCD039b415b-094a-da37-e063-6294a90a52d72
856457propranolol hydrochloride 20 MG Oral TabletSCD4d24ea79-ba56-44f4-b1a6-e27235176c4a2
856457propranolol hydrochloride 20 MG Oral TabletSCD1791ef4d-b609-41c8-b4ef-15bff752ddd72
856457propranolol hydrochloride 20 MG Oral TabletSCD039b415b-094a-da37-e063-6294a90a52d72
856519propranolol hydrochloride 40 MG Oral TabletSCD039b415b-094a-da37-e063-6294a90a52d72
856457propranolol HCl 20 MG Oral TabletPSN42def694-9484-a2ca-e063-6394a90a87d81
856457propranolol hydrochloride 20 MG Oral TabletSCD42def694-9484-a2ca-e063-6394a90a87d81

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69238-2078-169238207801100 TABLET in 1 BOTTLE (69238-2078-1) 100 tablet2021-06-030000-00-00NoNoCurrent
69238-2078-7692382078071000 TABLET in 1 BOTTLE (69238-2078-7) 1000 tablet2021-06-030000-00-00NoNoCurrent