FDA.reportPublic FDA data

NDC 51672-1309-01 - Betamethasone Dipropionate

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
51672-1309
Requested NDC
51672-1309-01
Package NDCs from labels
51672-1309-1, 51672-1309-3, 51672-1309-01
Manufacturer
Sun Pharmaceutical Industries, Inc. | Sun Pharma Canada Inc.
Effective date
2025-07-02
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Betamethasone Dipropionate Gel (Augmented*), 0.05%Sun Pharmaceutical Industries, Inc. | Sun Pharma Canada Inc.2025-07-02HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-1309-1Betamethasone Dipropionate15 g in 1 TUBEGEL156
51672-1309-1Betamethasone Dipropionate1 in 1 CARTONGEL16
51672-1309-3Betamethasone Dipropionate1 in 1 CARTONGEL16
51672-1309-3Betamethasone Dipropionate50 g in 1 TUBEGEL506

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-1309BETAMETHASONE DIPROPIONATE GEL [TARO PHARMACEUTICALS U.S.A., INC.]5Current NDC, Legacy NDC, 4 package rows20241222_e041ceb2-8bda-4703-b663-804e7b462e32.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-1309-1GM - Gram51672-13098f10039b-85a5-4ecd-bcea-3bab503cd15712012-07-24
51672-1309-3GM - Gram51672-1309aaa573ed-58dc-4041-9cbf-2a97c4d5b37612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Betamethasone DipropionateACTIVE INGREDIENT826Y60901UBETAMETHASONE DIPROPIONATE GEL [TARO PHARMACEUTICALS U.S.A., INC.]2
BetamethasoneACTIVE MOIETY9842X06Q6MBETAMETHASONE DIPROPIONATE GEL [TARO PHARMACEUTICALS U.S.A., INC.]2

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 8 of 17 · 334 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Systane COMPLETEPROPYLENE GLYCOLAlcon Laboratories, Inc.2df0de02-a3e2-471a-9e10-040c3fba75fe2025-08-08WarningsExact identifier
unii: 6DC9Q167V3
Betamethasone DipropionateBETAMETHASONE DIPROPIONATEBryant Ranch Prepackf2c557ea-275b-4ab4-90f4-4003e022214d2025-08-07Warnings, Adverse reactionsExact identifier
unii: 826Y60901U
Systane BalancePROPYLENE GLYCOLAlcon Laboratories, Inc.c7b1a03a-a5f2-409e-a34a-d6f166671de52025-08-07WarningsExact identifier
unii: 6DC9Q167V3
Systane UltraPOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.0537c23a-15f7-be64-1231-a6c93468e9a82025-07-30WarningsExact identifier
unii: 6DC9Q167V3
SystanePOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.1d679d0f-cec2-a644-79cd-079607254bb92025-07-30WarningsExact identifier
unii: 6DC9Q167V3
Systane Ultra Preservative FreePOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.751fb85f-6683-4b0a-a650-324d4a74c5de2025-07-30WarningsExact identifier
unii: 6DC9Q167V3
Systane COMPLETE PFPROPYLENE GLYCOLAlcon Laboratories, Inc.99b63d62-1cf0-4f28-8760-773917c2538a2025-07-29WarningsExact identifier
unii: 6DC9Q167V3
BETAMETHASONE DIPROPIONATEBETAMETHASONE DIPROPIONATEBryant Ranch Prepack52c0e92f-986e-45e7-99cf-9a13ac386b1d2025-07-28Adverse reactionsExact identifier
unii: 826Y60901U
Sterile WaterSTERILE WATERNephron Pharmaceuticals Corporationbc04a883-babc-87a6-e053-2995a90a3dfd2025-07-11Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Betamethasone DipropionateBETAMETHASONE DIPROPIONATEGolden State Medical Supply, Inc.9571a031-179d-7dfb-e053-2995a90aa0162025-07-10Adverse reactionsExact identifier
unii: 826Y60901U
Clotrimazole and Betamethasone DipropionateCLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATESun Pharmaceutical Industries, Inc.e4e9f244-4a85-4c0d-9917-93182c4a6e872025-07-07Adverse reactionsExact identifier
unii: 826Y60901U
Betamethasone DipropionateBETAMETHASONE DIPROPIONATESun Pharmaceutical Industries, Inc.3b23a3c0-3306-4a2d-932d-25916d16dc682025-07-07Warnings, Adverse reactionsExact identifier
unii: 826Y60901U
Betamethasone dipropionateBETAMETHASONE DIPROPIONATESun Pharmaceutical Industries, Inc.dc3dd2f7-38ad-4c4c-8602-29b33cc6af902025-07-07Warnings, Adverse reactionsExact identifier
unii: 826Y60901U
Betamethasone DipropionateBETAMETHASONE DIPROPIONATESun Pharmaceutical Industries, Inc.bc12c828-54ba-411d-b752-9b735f7adf632025-07-02Adverse reactionsExact identifier
unii: 826Y60901U
Betamethasone DipropionateBETAMETHASONE DIPROPIONATESun Pharmaceutical Industries, Inc.e041ceb2-8bda-4703-b663-804e7b462e322025-07-02Adverse reactionsExact identifier
application number: ANDA076508
ndc (package): 51672-1309-3
ndc (package): 51672-1309-1
ndc (product): 51672-1309
ndc11 (package): 51672130901
rxcui: 848208
spl id: 38f65f63-5416-f33d-e063-6294a90a4238
spl set id: e041ceb2-8bda-4703-b663-804e7b462e32
unii: 826Y60901U
Calcipotriene and Betamethasone DipropionateCALCIPOTRIENE AND BETAMETHASONE DIPROPIONATESun Pharmaceutical Industries, Inc.1d0ab2e6-1ab1-4d3e-ad55-7fa26446f1912025-07-01Warnings, Adverse reactionsExact identifier
unii: 826Y60901U
Plaque identifyingPLAQUE IDENTIFYINGShenzhen Yagao Technology Co., Ltd.37eeb656-22f1-7372-e063-6394a90ad0412025-06-19WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERHenry Schein, Inc.88403fcf-a276-42c0-88b6-bd84a720b5642025-05-29Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Eyesaline Emergency EyewashSTERILE EYESALINE EYEWASHHoneywell Safety Products USA, Inc.2d567518-4c54-7448-e063-6294a90a3e642025-05-14WarningsExact identifier
unii: 059QF0KO0R
Betamethasone DipropionateBETAMETHASONE DIPROPIONATENuCare Pharmaceuticals,Inc.75862805-2cfc-fb45-e053-2991aa0a14032025-04-03Warnings, Adverse reactionsExact identifier
unii: 826Y60901U

Reported adverse events (FAERS/openFDA)#

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