FDA.reportPublic FDA data

Calcipotriene

Product NDC
0168-0400
11-digit product format
001680400
Labeler code
0168
Product ID
0168-0400_774dd89d-ce05-4c00-8770-e89c23865a26
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Calcipotriene
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Fougera Pharmaceuticals Inc.
Application
ANDA078305
Marketing category
ANDA
Marketing start
2008-05-06
Marketing end
0000-00-00
Substance
CALCIPOTRIENE
Active strength
0 mg/mL
Pharmacologic classes
Vitamin D [CS],Vitamin D Analog [EPC]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

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

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0168-0400DDiscontinued by firm2026-07-31
excluded packagepackage0168-04000168-0400-60DDiscontinued by firm2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A078305-001CALCIPOTRIENECALCIPOTRIENE0.005%SOLUTION / TOPICALAT2008-05-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A078305-001AT

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A078305-001CALCIPOTRIENE0.005%SOLUTION / TOPICALAT2008-05-06a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A078305-001AT1a50c72e98297…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0168-0400-602020-09-17C16284748780-1ab0e2407-348e-f274-e053-dbdaa90a6471CALCIPOTRIENE TOPICAL SOLUTION 0.005% (Scalp Solution)
0168-0400-602020-07-22C16284748780-1ab0e2407-348e-f274-e053-dbdaa90a6471CALCIPOTRIENE TOPICAL SOLUTION 0.005% (Scalp Solution)

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0168-0400-60ML - Milliliter0168-04008f030b6e-b1d5-4bf7-b9e9-08b5f17b04a412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
calcipotrieneACTIVE INGREDIENT143NQ3779BCALCIPOTRIENE SOLUTION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]3
calcipotrieneACTIVE MOIETY143NQ3779BCALCIPOTRIENE SOLUTION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]3
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PCALCIPOTRIENE SOLUTION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]3
isopropyl alcoholINACTIVE INGREDIENTND2M416302CALCIPOTRIENE SOLUTION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]3
mentholINACTIVE INGREDIENTL7T10EIP3ACALCIPOTRIENE SOLUTION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]3
propylene glycolINACTIVE INGREDIENT6DC9Q167V3CALCIPOTRIENE SOLUTION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]3
sodium citrateINACTIVE INGREDIENT1Q73Q2JULRCALCIPOTRIENE SOLUTION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]3
waterINACTIVE INGREDIENT059QF0KO0RCALCIPOTRIENE SOLUTION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0168-0400-600016804006060 mL in 1 BOTTLE, PLASTIC (0168-0400-60) 60 ml2008-05-060000-00-00NoNoCurrent