FDA.reportPublic FDA data

Betamethasone Valerate

Product NDC
0168-0040
11-digit product format
001680040
Labeler code
0168
Product ID
0168-0040_41e96a74-4120-436e-97e5-2dc62af84b2a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
betamethasone valerate
Dosage form
CREAM
Route
TOPICAL
Labeler
E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC
Application
NDA018861
Marketing category
NDA
Marketing start
1983-08-31
Substance
BETAMETHASONE VALERATE
Active strength
1 mg/g
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Betamethasone Valerate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BETAMETHASONE VALERATE1 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9IFA5XM7R2
Rxcui197407, 197408, 197409

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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
1dbefad7-ab34-69c3-e51a-e7148aa38f70Product name520220921
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0168-0040-152020-09-01C16284748780-1ab0e2407-3446-f274-e053-dbdaa90a6471BETAMETHASONE VALERATE CREAM USP, 0.1% BETAMETHASONE VALERATE OINTMENT USP, 0.1% BETAMETHASONE VALERATE LOTION USP, 0.1% (Potency expressed as betamethasone)
0168-0040-462020-09-01C16284748780-1ab0e2407-3446-f274-e053-dbdaa90a6471BETAMETHASONE VALERATE CREAM USP, 0.1% BETAMETHASONE VALERATE OINTMENT USP, 0.1% BETAMETHASONE VALERATE LOTION USP, 0.1% (Potency expressed as betamethasone)
0168-0040-152020-07-22C16284748780-1ab0e2407-3446-f274-e053-dbdaa90a6471BETAMETHASONE VALERATE CREAM USP, 0.1% BETAMETHASONE VALERATE OINTMENT USP, 0.1% BETAMETHASONE VALERATE LOTION USP, 0.1% (Potency expressed as betamethasone)
0168-0040-462020-07-22C16284748780-1ab0e2407-3446-f274-e053-dbdaa90a6471BETAMETHASONE VALERATE CREAM USP, 0.1% BETAMETHASONE VALERATE OINTMENT USP, 0.1% BETAMETHASONE VALERATE LOTION USP, 0.1% (Potency expressed as betamethasone)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0168-0040-15Betamethasone Valerate15 g in 1 TUBECREAM1510
0168-0040-46Betamethasone Valerate45 g in 1 TUBECREAM4510

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0168-0040-15GM - Gram0168-0040665da8f6-4116-459c-8a77-63257ef7a20512012-07-24
0168-0040-46GM - Gram0168-004064038fd5-0f9b-4802-9a90-1e21f0d0cbf612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BETAMETHASONE VALERATEACTIVE INGREDIENT9IFA5XM7R2BETAMETHASONE VALERATE CREAM BETAMETHASONE VALERATE OINTMENT BETAMETHASONE VALERATE LOTION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]5
BETAMETHASONEACTIVE MOIETY9842X06Q6MBETAMETHASONE VALERATE CREAM BETAMETHASONE VALERATE OINTMENT BETAMETHASONE VALERATE LOTION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]5
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)INACTIVE INGREDIENTZ135WT9208BETAMETHASONE VALERATE CREAM BETAMETHASONE VALERATE OINTMENT BETAMETHASONE VALERATE LOTION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]5
CETETH-20INACTIVE INGREDIENTI835H2IHHXBETAMETHASONE VALERATE CREAM BETAMETHASONE VALERATE OINTMENT BETAMETHASONE VALERATE LOTION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]5
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SBETAMETHASONE VALERATE CREAM BETAMETHASONE VALERATE OINTMENT BETAMETHASONE VALERATE LOTION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]5
CHLOROCRESOLINACTIVE INGREDIENT36W53O7109BETAMETHASONE VALERATE CREAM BETAMETHASONE VALERATE OINTMENT BETAMETHASONE VALERATE LOTION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]5
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302BETAMETHASONE VALERATE CREAM BETAMETHASONE VALERATE OINTMENT BETAMETHASONE VALERATE LOTION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]5
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPBETAMETHASONE VALERATE CREAM BETAMETHASONE VALERATE OINTMENT BETAMETHASONE VALERATE LOTION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]5
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UBETAMETHASONE VALERATE CREAM BETAMETHASONE VALERATE OINTMENT BETAMETHASONE VALERATE LOTION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]5
PHOSPHORIC ACIDINACTIVE INGREDIENTE4GA8884NNBETAMETHASONE VALERATE CREAM BETAMETHASONE VALERATE OINTMENT BETAMETHASONE VALERATE LOTION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]5
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IBETAMETHASONE VALERATE CREAM BETAMETHASONE VALERATE OINTMENT BETAMETHASONE VALERATE LOTION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]5
SODIUM PHOSPHATE, MONOBASICINACTIVE INGREDIENT3980JIH2SWBETAMETHASONE VALERATE CREAM BETAMETHASONE VALERATE OINTMENT BETAMETHASONE VALERATE LOTION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]5
WATERINACTIVE INGREDIENT059QF0KO0RBETAMETHASONE VALERATE CREAM BETAMETHASONE VALERATE OINTMENT BETAMETHASONE VALERATE LOTION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]5
BETAMETHASONE VALERATEACTIVE INGREDIENT9IFA5XM7R2BETAMETHASONE VALERATE CREAM [STAT RX USA LLC]2
BETAMETHASONEACTIVE MOIETY9842X06Q6MBETAMETHASONE VALERATE CREAM [STAT RX USA LLC]2
WATERINACTIVE INGREDIENT059QF0KO0RBETAMETHASONE VALERATE CREAM [STAT RX USA LLC]2
BETAMETHASONE VALERATEACTIVE INGREDIENT9IFA5XM7R2BETAMETHASONE VALERATE CREAM BETAMETHASONE VALERATE OINTMENT BETAMETHASONE VALERATE LOTION [PHYSICIANS TOTAL CARE, INC.]1
BETAMETHASONE VALERATEACTIVE MOIETY9IFA5XM7R2BETAMETHASONE VALERATE CREAM BETAMETHASONE VALERATE OINTMENT BETAMETHASONE VALERATE LOTION [PHYSICIANS TOTAL CARE, INC.]1
CETETH-20INACTIVE INGREDIENTI835H2IHHXBETAMETHASONE VALERATE CREAM BETAMETHASONE VALERATE OINTMENT BETAMETHASONE VALERATE LOTION [PHYSICIANS TOTAL CARE, INC.]1
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SBETAMETHASONE VALERATE CREAM BETAMETHASONE VALERATE OINTMENT BETAMETHASONE VALERATE LOTION [PHYSICIANS TOTAL CARE, INC.]1
CHLOROCRESOLINACTIVE INGREDIENT36W53O7109BETAMETHASONE VALERATE CREAM BETAMETHASONE VALERATE OINTMENT BETAMETHASONE VALERATE LOTION [PHYSICIANS TOTAL CARE, INC.]1
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302BETAMETHASONE VALERATE CREAM BETAMETHASONE VALERATE OINTMENT BETAMETHASONE VALERATE LOTION [PHYSICIANS TOTAL CARE, INC.]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPBETAMETHASONE VALERATE CREAM BETAMETHASONE VALERATE OINTMENT BETAMETHASONE VALERATE LOTION [PHYSICIANS TOTAL CARE, INC.]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UBETAMETHASONE VALERATE CREAM BETAMETHASONE VALERATE OINTMENT BETAMETHASONE VALERATE LOTION [PHYSICIANS TOTAL CARE, INC.]1
PHOSPHORIC ACIDINACTIVE INGREDIENTE4GA8884NNBETAMETHASONE VALERATE CREAM BETAMETHASONE VALERATE OINTMENT BETAMETHASONE VALERATE LOTION [PHYSICIANS TOTAL CARE, INC.]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IBETAMETHASONE VALERATE CREAM BETAMETHASONE VALERATE OINTMENT BETAMETHASONE VALERATE LOTION [PHYSICIANS TOTAL CARE, INC.]1
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEINACTIVE INGREDIENT593YOG76RNBETAMETHASONE VALERATE CREAM BETAMETHASONE VALERATE OINTMENT BETAMETHASONE VALERATE LOTION [PHYSICIANS TOTAL CARE, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RBETAMETHASONE VALERATE CREAM BETAMETHASONE VALERATE OINTMENT BETAMETHASONE VALERATE LOTION [PHYSICIANS TOTAL CARE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0168-0040BETAMETHASONE VALERATE CREAM BETAMETHASONE VALERATE OINTMENT BETAMETHASONE VALERATE LOTION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]9Current NDC, Legacy NDC, 2 package rows20220112_0b386ccc-a2d4-4d18-a2d7-e46ff894c674.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197407betamethasone 0.1 % Topical CreamPSN0b386ccc-a2d4-4d18-a2d7-e46ff894c67410
197408betamethasone valerate 0.1 % Topical LotionPSN0b386ccc-a2d4-4d18-a2d7-e46ff894c67410
197409betamethasone valerate 0.1 % Topical OintmentPSN0b386ccc-a2d4-4d18-a2d7-e46ff894c67410
197409betamethasone 0.001 MG/MG Topical OintmentSCD0b386ccc-a2d4-4d18-a2d7-e46ff894c67410
197407betamethasone 1 MG/ML Topical CreamSCD0b386ccc-a2d4-4d18-a2d7-e46ff894c67410
197408betamethasone 1 MG/ML Topical LotionSCD0b386ccc-a2d4-4d18-a2d7-e46ff894c67410
197407betamethasone 0.1 % Topical CreamSY0b386ccc-a2d4-4d18-a2d7-e46ff894c67410
197408betamethasone 0.1 % Topical LotionSY0b386ccc-a2d4-4d18-a2d7-e46ff894c67410
197409betamethasone 0.1 % Topical OintmentSY0b386ccc-a2d4-4d18-a2d7-e46ff894c67410
197409betamethasone 1 MG/GM (as betamethasone valerate 1.2 MG/GM) Topical OintmentSY0b386ccc-a2d4-4d18-a2d7-e46ff894c67410
197407betamethasone 1 MG/ML (as betamethasone valerate 1.2 MG/ML) Topical CreamSY0b386ccc-a2d4-4d18-a2d7-e46ff894c67410
197408betamethasone 1 MG/ML (betamethasone valerate 1.2 MG/ML) Topical LotionSY0b386ccc-a2d4-4d18-a2d7-e46ff894c67410
197407betamethasone 0.1 % Topical CreamPSN06e431f0-9952-4549-a28e-51157356d7a85
197407betamethasone 0.1 % Topical CreamPSN036706f1-0a24-4765-9a62-820ad64934be5
197407betamethasone 1 MG/ML Topical CreamSCD06e431f0-9952-4549-a28e-51157356d7a85
197407betamethasone 1 MG/ML Topical CreamSCD036706f1-0a24-4765-9a62-820ad64934be5
197407betamethasone 0.1 % Topical CreamSY036706f1-0a24-4765-9a62-820ad64934be5
197407betamethasone 0.1 % Topical CreamSY06e431f0-9952-4549-a28e-51157356d7a85
197407betamethasone 1 MG/ML (as betamethasone valerate 1.2 MG/ML) Topical CreamSY06e431f0-9952-4549-a28e-51157356d7a85
197407betamethasone 1 MG/ML (as betamethasone valerate 1.2 MG/ML) Topical CreamSY036706f1-0a24-4765-9a62-820ad64934be5
197407betamethasone 0.1 % Topical CreamPSN985d1f62-4bff-4bf1-b7c7-96cb456ef83d3
197407betamethasone 1 MG/ML Topical CreamSCD985d1f62-4bff-4bf1-b7c7-96cb456ef83d3
197407betamethasone 0.1 % Topical CreamSY985d1f62-4bff-4bf1-b7c7-96cb456ef83d3
197407betamethasone 1 MG/ML (as betamethasone valerate 1.2 MG/ML) Topical CreamSY985d1f62-4bff-4bf1-b7c7-96cb456ef83d3
197407betamethasone 0.1 % Topical CreamPSN475eeaf4-d675-49fb-b1be-6575159684462
197407betamethasone 1 MG/ML Topical CreamSCD475eeaf4-d675-49fb-b1be-6575159684462
197407betamethasone 0.1 % Topical CreamSY475eeaf4-d675-49fb-b1be-6575159684462
197407betamethasone 1 MG/ML (as betamethasone valerate 1.2 MG/ML) Topical CreamSY475eeaf4-d675-49fb-b1be-6575159684462
197407betamethasone 0.1 % Topical CreamPSN72bcd320-39d6-49db-bc7b-d140d200076a1
197407betamethasone 0.1 % Topical CreamPSN1c5635e9-2ac3-df35-e063-6294a90a7f431
197408betamethasone valerate 0.1 % Topical LotionPSN72bcd320-39d6-49db-bc7b-d140d200076a1
197409betamethasone valerate 0.1 % Topical OintmentPSN72bcd320-39d6-49db-bc7b-d140d200076a1
197409betamethasone 0.001 MG/MG Topical OintmentSCD72bcd320-39d6-49db-bc7b-d140d200076a1
197407betamethasone 1 MG/ML Topical CreamSCD1c5635e9-2ac3-df35-e063-6294a90a7f431
197407betamethasone 1 MG/ML Topical CreamSCD72bcd320-39d6-49db-bc7b-d140d200076a1
197408betamethasone 1 MG/ML Topical LotionSCD72bcd320-39d6-49db-bc7b-d140d200076a1
197407betamethasone 0.1 % Topical CreamSY72bcd320-39d6-49db-bc7b-d140d200076a1
197407betamethasone 0.1 % Topical CreamSY1c5635e9-2ac3-df35-e063-6294a90a7f431
197408betamethasone 0.1 % Topical LotionSY72bcd320-39d6-49db-bc7b-d140d200076a1
197409betamethasone 0.1 % Topical OintmentSY72bcd320-39d6-49db-bc7b-d140d200076a1
197409betamethasone 1 MG/GM (as betamethasone valerate 1.2 MG/GM) Topical OintmentSY72bcd320-39d6-49db-bc7b-d140d200076a1
197407betamethasone 1 MG/ML (as betamethasone valerate 1.2 MG/ML) Topical CreamSY72bcd320-39d6-49db-bc7b-d140d200076a1
197407betamethasone 1 MG/ML (as betamethasone valerate 1.2 MG/ML) Topical CreamSY1c5635e9-2ac3-df35-e063-6294a90a7f431
197408betamethasone 1 MG/ML (betamethasone valerate 1.2 MG/ML) Topical LotionSY72bcd320-39d6-49db-bc7b-d140d200076a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0168-0040-150016800401515 g in 1 TUBE (0168-0040-15) 15 g1983-08-310000-00-00NoNoCurrent
0168-0040-460016800404645 g in 1 TUBE (0168-0040-46) 45 g1983-08-310000-00-00NoNoCurrent