FDA.reportPublic FDA data

BETAMETHASONE VALERATE

Product NDC
51672-1269
11-digit product format
516721269
Labeler code
51672
Product ID
51672-1269_40339862-869b-f954-e063-6294a90a9add
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Betamethasone Valerate
Dosage form
CREAM
Route
TOPICAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA072041
Marketing category
ANDA
Marketing start
1988-01-06
Substance
BETAMETHASONE VALERATE
Active strength
1 mg/g
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
BETAMETHASONE VALERATE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BETAMETHASONE VALERATE1 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9IFA5XM7R2
Rxcui197407

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dde7b902-54a1-627e-12f1-9e6d244ab88cProduct name420250317
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
69b49899-11cf-4f7e-bd0a-7dc93b27311bProduct name320250130
bbdc14c7-d940-43b5-a2f7-36c425991f3cProduct name120240320
0a2fcc35-464b-9ec2-a622-753662cdd48cProduct name320240216
6f762601-17ef-4321-8f47-77783d3c4d8bProduct name320231116
1dbefad7-ab34-69c3-e51a-e7148aa38f70Product name520220921
7fea2046-07a9-4bb6-9409-828ac6f1f6dfProduct name120210201
f059f1a2-0e64-4839-9a7f-42687c91a44bProduct name120201007
4ea9e4b5-b452-48ad-9b25-b9a4d403405dProduct name120160310
f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6Product name220151106
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
4f07db9b-3707-3e2c-05b5-d7852ba808c4Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-1269-1BETAMETHASONE VALERATE15 g in 1 TUBECREAM156
51672-1269-1BETAMETHASONE VALERATE1 in 1 CARTONCREAM16
51672-1269-6BETAMETHASONE VALERATE45 g in 1 TUBECREAM456
51672-1269-6BETAMETHASONE VALERATE1 in 1 CARTONCREAM16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-1269-1GM - Gram51672-1269691dc7cc-daf4-4bfa-94b1-c2187299bd6612012-07-24
51672-1269-6GM - Gram51672-1269d1ff27c2-3a77-417a-958c-fb5c6fe2779e12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Betamethasone ValerateACTIVE INGREDIENT9IFA5XM7R2BETAMETHASONE VALERATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
BetamethasoneACTIVE MOIETY9842X06Q6MBETAMETHASONE VALERATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
ceteareth-15INACTIVE INGREDIENT867H4YOZ8ZBETAMETHASONE VALERATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
cetyl alcoholINACTIVE INGREDIENT936JST6JCNBETAMETHASONE VALERATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
mineral oilINACTIVE INGREDIENTT5L8T28FGPBETAMETHASONE VALERATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
petrolatumINACTIVE INGREDIENT4T6H12BN9UBETAMETHASONE VALERATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
polyethylene glycol 1000INACTIVE INGREDIENTU076Q6Q621BETAMETHASONE VALERATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
propylene glycolINACTIVE INGREDIENT6DC9Q167V3BETAMETHASONE VALERATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
stearyl alcoholINACTIVE INGREDIENT2KR89I4H1YBETAMETHASONE VALERATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
waterINACTIVE INGREDIENT059QF0KO0RBETAMETHASONE VALERATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
Betamethasone ValerateACTIVE INGREDIENT9IFA5XM7R2BETAMETHASONE VALERATE CREAM [REBEL DISTRIBUTORS CORP.]1
BetamethasoneACTIVE MOIETY9842X06Q6MBETAMETHASONE VALERATE CREAM [REBEL DISTRIBUTORS CORP.]1
CETETH-20INACTIVE INGREDIENTI835H2IHHXBETAMETHASONE VALERATE CREAM [REBEL DISTRIBUTORS CORP.]1
cetyl alcoholINACTIVE INGREDIENT936JST6JCNBETAMETHASONE VALERATE CREAM [REBEL DISTRIBUTORS CORP.]1
CHLOROCRESOLINACTIVE INGREDIENT36W53O7109BETAMETHASONE VALERATE CREAM [REBEL DISTRIBUTORS CORP.]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPBETAMETHASONE VALERATE CREAM [REBEL DISTRIBUTORS CORP.]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UBETAMETHASONE VALERATE CREAM [REBEL DISTRIBUTORS CORP.]1
phosphoric acidINACTIVE INGREDIENTE4GA8884NNBETAMETHASONE VALERATE CREAM [REBEL DISTRIBUTORS CORP.]1
propylene glycolINACTIVE INGREDIENT6DC9Q167V3BETAMETHASONE VALERATE CREAM [REBEL DISTRIBUTORS CORP.]1
sodium hydroxideINACTIVE INGREDIENT55X04QC32IBETAMETHASONE VALERATE CREAM [REBEL DISTRIBUTORS CORP.]1
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEINACTIVE INGREDIENT593YOG76RNBETAMETHASONE VALERATE CREAM [REBEL DISTRIBUTORS CORP.]1
stearyl alcoholINACTIVE INGREDIENT2KR89I4H1YBETAMETHASONE VALERATE CREAM [REBEL DISTRIBUTORS CORP.]1
waterINACTIVE INGREDIENT059QF0KO0RBETAMETHASONE VALERATE CREAM [REBEL DISTRIBUTORS CORP.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-1269BETAMETHASONE VALERATE CREAM [SUN PHARMACEUTICAL INDUSTRIES, INC.]5Current NDC, Legacy NDC, 4 package rows20250529_3c85be0f-2731-44f1-a18e-d3852d54846f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197407betamethasone 0.1 % Topical CreamPSN02db1402-701c-483c-bfd6-8b7a543ae8ef11
197407betamethasone 1 MG/ML Topical CreamSCD02db1402-701c-483c-bfd6-8b7a543ae8ef11
197407betamethasone 0.1 % Topical CreamSY02db1402-701c-483c-bfd6-8b7a543ae8ef11
197407betamethasone 1 MG/ML (as betamethasone valerate 1.2 MG/ML) Topical CreamSY02db1402-701c-483c-bfd6-8b7a543ae8ef11
197407betamethasone 0.1 % Topical CreamPSN7281d272-5342-4738-b35c-42570459e9d410
197407betamethasone 1 MG/ML Topical CreamSCD7281d272-5342-4738-b35c-42570459e9d410
197407betamethasone 0.1 % Topical CreamSY7281d272-5342-4738-b35c-42570459e9d410
197407betamethasone 1 MG/ML (as betamethasone valerate 1.2 MG/ML) Topical CreamSY7281d272-5342-4738-b35c-42570459e9d410
197407betamethasone 0.1 % Topical CreamPSNbfa4b6f5-3b66-430a-af41-60e3f12982bc8
197407betamethasone 1 MG/ML Topical CreamSCDbfa4b6f5-3b66-430a-af41-60e3f12982bc8
197407betamethasone 0.1 % Topical CreamSYbfa4b6f5-3b66-430a-af41-60e3f12982bc8
197407betamethasone 1 MG/ML (as betamethasone valerate 1.2 MG/ML) Topical CreamSYbfa4b6f5-3b66-430a-af41-60e3f12982bc8
197407betamethasone 0.1 % Topical CreamPSN3c85be0f-2731-44f1-a18e-d3852d54846f6
197407betamethasone 1 MG/ML Topical CreamSCD3c85be0f-2731-44f1-a18e-d3852d54846f6
197407betamethasone 0.1 % Topical CreamSY3c85be0f-2731-44f1-a18e-d3852d54846f6
197407betamethasone 1 MG/ML (as betamethasone valerate 1.2 MG/ML) Topical CreamSY3c85be0f-2731-44f1-a18e-d3852d54846f6
197407betamethasone 0.1 % Topical CreamPSN64badc1a-8922-c6e3-e053-2991aa0a8b1c4
197407betamethasone 1 MG/ML Topical CreamSCD64badc1a-8922-c6e3-e053-2991aa0a8b1c4
197407betamethasone 0.1 % Topical CreamSY64badc1a-8922-c6e3-e053-2991aa0a8b1c4
197407betamethasone 1 MG/ML (as betamethasone valerate 1.2 MG/ML) Topical CreamSY64badc1a-8922-c6e3-e053-2991aa0a8b1c4
197407betamethasone 0.1 % Topical CreamPSN68aa1460-a6d1-4c1e-bbfb-15e95d9ee2081
197407betamethasone 0.1 % Topical CreamPSNf242cdf5-6921-431f-8add-4d17887ebc931
197407betamethasone 1 MG/ML Topical CreamSCD68aa1460-a6d1-4c1e-bbfb-15e95d9ee2081
197407betamethasone 1 MG/ML Topical CreamSCDf242cdf5-6921-431f-8add-4d17887ebc931
197407betamethasone 0.1 % Topical CreamSYf242cdf5-6921-431f-8add-4d17887ebc931
197407betamethasone 0.1 % Topical CreamSY68aa1460-a6d1-4c1e-bbfb-15e95d9ee2081
197407betamethasone 1 MG/ML (as betamethasone valerate 1.2 MG/ML) Topical CreamSYf242cdf5-6921-431f-8add-4d17887ebc931
197407betamethasone 1 MG/ML (as betamethasone valerate 1.2 MG/ML) Topical CreamSY68aa1460-a6d1-4c1e-bbfb-15e95d9ee2081

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51672-1269-1516721269011 TUBE in 1 CARTON (51672-1269-1) / 15 g in 1 TUBE1 tube1988-01-060000-00-00NoNoCurrent
51672-1269-6516721269061 TUBE in 1 CARTON (51672-1269-6) / 45 g in 1 TUBE1 tube1988-01-060000-00-00NoNoCurrent