FDA.reportPublic FDA data

Propranolol Hydrochloride

Product NDC
50090-0146
Requested package NDC
50090-0146-5
11-digit product format
500900146
Labeler code
50090
Product ID
50090-0146_9e1c6f90-de2f-4213-8f9b-03fdab19b9b4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
propranolol hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA070217
Marketing category
ANDA
Marketing start
2010-06-21
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
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage50090-014650090-0146-5DDiscontinued by firm2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50090-014650090-0146-5DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50090-014650090-0146-5DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

Source provenance: Browse the complete Orange Book source catalog.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
50090-0146-02023-03-02Propranolol Hydrochloride Tablets, USP Rx only
50090-0146-12023-03-02Propranolol Hydrochloride Tablets, USP Rx only
50090-0146-22023-03-02Propranolol Hydrochloride Tablets, USP Rx only
50090-0146-52023-03-02Propranolol Hydrochloride Tablets, USP Rx only
50090-0146-02023-01-30Propranolol Hydrochloride Tablets, USP Rx only
50090-0146-12023-01-30Propranolol Hydrochloride Tablets, USP Rx only
50090-0146-22023-01-30Propranolol Hydrochloride Tablets, USP Rx only
50090-0146-52023-01-30Propranolol Hydrochloride Tablets, USP Rx only

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0146-1EA - Each50090-01460e51850a-f282-4306-8917-889ebea022db12018-08-13
50090-0146-5EA - Each50090-0146f6211e21-2bc6-458b-9510-b315a7f7141c12021-05-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PROPRANOLOL HYDROCHLORIDEACTIVE INGREDIENTF8A3652H1VPROPRANOLOL HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]1
PROPRANOLOLACTIVE MOIETY9Y8NXQ24VQPROPRANOLOL HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKPROPRANOLOL HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPROPRANOLOL HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48PROPRANOLOL HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GPROPRANOLOL HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPROPRANOLOL HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKPROPRANOLOL HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8PROPRANOLOL HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PROPRANOLOL HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PROPRANOLOL HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]1

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDEDIRECT RXa834d1cf-72fc-93bf-e053-2995a90a61912025-01-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070217
application number: ANDA070217
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDENuCare Pharmaceuticals,Inc.92c4bd8f-d0e6-d11a-e053-2995a90a635d2024-08-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070217
application number: ANDA070217

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-0146-55009001460590 TABLET in 1 BOTTLE (50090-0146-5) 90 tablet2019-07-050000-00-00NoNoCurrent