FDA.reportPublic FDA data

Propranolol Hydrochloride

Product NDC
69238-2077
11-digit product format
692382077
Labeler code
69238
Product ID
69238-2077_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
10 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 HYDROCHLORIDE10 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
69238-2077-1Propranolol Hydrochloride100 in 1 BOTTLETABLET1005
69238-2077-7Propranolol Hydrochloride1000 in 1 BOTTLETABLET10005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69238-2077-1EA - Each69238-20770c403b97-c175-4707-bc1c-6a7ceba5e79012022-02-07
69238-2077-7EA - Each69238-20771fa85505-2c99-4cb1-b654-4567201269fc12021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69238-2077PROPRANOLOL 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 TabletPSN1cd914b6-b250-4b11-8404-41db3589361e8
856448propranolol hydrochloride 10 MG Oral TabletSCD1cd914b6-b250-4b11-8404-41db3589361e8
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 TabletPSN013a485a-4227-46ae-b19f-c550302fcb964
856519propranolol HCl 40 MG Oral TabletPSN013a485a-4227-46ae-b19f-c550302fcb964
856448propranolol hydrochloride 10 MG Oral TabletSCD013a485a-4227-46ae-b19f-c550302fcb964
856519propranolol hydrochloride 40 MG Oral TabletSCD013a485a-4227-46ae-b19f-c550302fcb964
856448propranolol HCl 10 MG Oral TabletPSNf76b7edc-6d7d-9cba-e053-6294a90a035c3
856448propranolol HCl 10 MG Oral TabletPSNe7218c9b-b9b8-4cf0-a2c7-c759ad3a65ba3
856448propranolol HCl 10 MG Oral TabletPSNa21eb31b-db50-47a5-8f4c-315c2a842c8b3
856457propranolol HCl 20 MG Oral TabletPSNe7218c9b-b9b8-4cf0-a2c7-c759ad3a65ba3
856448propranolol hydrochloride 10 MG Oral TabletSCDf76b7edc-6d7d-9cba-e053-6294a90a035c3
856448propranolol hydrochloride 10 MG Oral TabletSCDe7218c9b-b9b8-4cf0-a2c7-c759ad3a65ba3
856448propranolol hydrochloride 10 MG Oral TabletSCDa21eb31b-db50-47a5-8f4c-315c2a842c8b3
856457propranolol hydrochloride 20 MG Oral TabletSCDe7218c9b-b9b8-4cf0-a2c7-c759ad3a65ba3
856448propranolol HCl 10 MG Oral TabletPSNd1110a10-a7f4-4295-9e94-8fbb56f77f672
856448propranolol HCl 10 MG Oral TabletPSNd9759182-e681-4c7e-af36-9f7b2184df3c2
856448propranolol HCl 10 MG Oral TabletPSN039b415b-094a-da37-e063-6294a90a52d72
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 TabletSCDd1110a10-a7f4-4295-9e94-8fbb56f77f672
856448propranolol hydrochloride 10 MG Oral TabletSCDd9759182-e681-4c7e-af36-9f7b2184df3c2
856448propranolol hydrochloride 10 MG Oral TabletSCD039b415b-094a-da37-e063-6294a90a52d72
856457propranolol hydrochloride 20 MG Oral TabletSCD039b415b-094a-da37-e063-6294a90a52d72
856519propranolol hydrochloride 40 MG Oral TabletSCD039b415b-094a-da37-e063-6294a90a52d72
856448propranolol HCl 10 MG Oral TabletPSN29acc74e-79b5-f668-e063-6394a90aef9b1
856448propranolol hydrochloride 10 MG Oral TabletSCD29acc74e-79b5-f668-e063-6394a90aef9b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69238-2077-169238207701100 TABLET in 1 BOTTLE (69238-2077-1) 100 tablet2021-06-030000-00-00NoNoCurrent
69238-2077-7692382077071000 TABLET in 1 BOTTLE (69238-2077-7) 1000 tablet2021-06-030000-00-00NoNoCurrent