FDA.reportPublic FDA data

FABIOR

Product NDC
51862-295
11-digit product format
518620295
Labeler code
51862
Product ID
51862-295_4c23641b-0092-4d63-e063-6394a90aa62e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tazarotene
Dosage form
AEROSOL, FOAM
Route
TOPICAL
Labeler
Mayne Pharma
Application
NDA202428
Marketing category
NDA
Marketing start
2017-03-10
Substance
TAZAROTENE
Active strength
1 mg/g
Pharmacologic classes
Retinoid [EPC], Retinoids [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TAZAROTENE1 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii81BDR9Y8PS
Rxcui1293451, 1293456

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a107c35c-2cb4-4734-a92b-e9ed5cfc34d6Product name220260220
5993ea1b-833d-fa4b-caad-a0d477537538Product name520250305
c24b0f4e-b27e-8e2b-a129-1b5a6d72c459Product name220231128
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
18da2240-e326-4d63-90cd-d6bb15f662a0Product name120200604
a32b252c-8cd2-cc4a-c64c-4b9d3916df9eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51862-295-10FABIOR1 in 1 CARTONAEROSOL, FOAM17
51862-295-10FABIOR100 g in 1 CANAEROSOL, FOAM1007
51862-295-50FABIOR50 g in 1 CANAEROSOL, FOAM507
51862-295-50FABIOR1 in 1 CARTONAEROSOL, FOAM17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51862-295-10GM - Gram51862-295436da915-ce0b-40e6-a10d-c92446d56e8d12017-04-05
51862-295-50GM - Gram51862-2958891b29a-6330-4e7d-8c54-ba458f88414812017-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51862-295FABIOR (TAZAROTENE) AEROSOL, FOAM [MAYNE PHARMA]5Current NDC, Legacy NDC, 4 package rows20240511_ae0afed7-1d60-45fd-a08b-8db094618521.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1293456Fabior 0.1 % Topical FoamPSNae0afed7-1d60-45fd-a08b-8db0946185217
1293451tazarotene 0.1 % Topical FoamPSNae0afed7-1d60-45fd-a08b-8db0946185217
1293456tazarotene 1 MG/ML Topical Foam [Fabior]SBDae0afed7-1d60-45fd-a08b-8db0946185217
1293451tazarotene 1 MG/ML Topical FoamSCDae0afed7-1d60-45fd-a08b-8db0946185217
1293456Fabior 0.1 % Topical FoamSYae0afed7-1d60-45fd-a08b-8db0946185217
1293456Fabior 1 MG/ML Topical FoamSYae0afed7-1d60-45fd-a08b-8db0946185217
1293451tazarotene 0.1 % Topical FoamSYae0afed7-1d60-45fd-a08b-8db0946185217

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51862-295-10518620295101 CAN in 1 CARTON (51862-295-10) / 100 g in 1 CAN1 can2017-03-170000-00-00NoNoCurrent
51862-295-50518620295501 CAN in 1 CARTON (51862-295-50) > 50 g in 1 CAN1 can2017-03-100000-00-00NoNoCurrent