FDA.reportPublic FDA data

Claravis

Product NDC
0555-1054
11-digit product format
005551054
Labeler code
0555
Product ID
0555-1054_a69dde5d-5585-4313-be43-02d11fec4c9f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Isotretinoin
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA076356
Marketing category
ANDA
Marketing start
2003-05-09
Substance
ISOTRETINOIN
Active strength
10 mg/1
Pharmacologic classes
Retinoid [EPC], Retinoids [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ISOTRETINOIN10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiEH28UP18IF
Rxcui197843, 197844, 197845, 403930, 404059, 404062, 404065, 643488

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
8300c0f6-79a4-735b-88ec-d781bfffdb10Product name520260305
644afe93-ba9b-4043-8e40-a9fe9af2d5d7Product name220250616
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
e5fedfa5-6b96-4769-872b-95d1e7f3a85aProduct name120200415
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0555-1054-56Claravis10 in 1 CARTONCAPSULE, LIQUID FILLED1018
0555-1054-60Claravis10 in 1 BLISTER PACKCAPSULE, LIQUID FILLED1018
0555-1054-86Claravis3 in 1 CARTONCAPSULE, LIQUID FILLED318

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0555-1054-56EA - Each0555-1054a9acbe08-a1c6-41e1-bb53-9e1d9202c21312012-07-24
0555-1054-60EA - Each0555-1054f8bdf419-4836-4944-83fd-ca9a604082a812019-07-02
0555-1054-86EA - Each0555-105479b7e708-2eef-4586-820a-caa99506f76712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ISOTRETINOINACTIVE INGREDIENTEH28UP18IFCLARAVIS (ISOTRETINOIN) CAPSULE [BARR LABORATORIES, INC.]8
ISOTRETINOINACTIVE MOIETYEH28UP18IFCLARAVIS (ISOTRETINOIN) CAPSULE [BARR LABORATORIES, INC.]8
.ALPHA.-TOCOPHEROLINACTIVE INGREDIENTH4N855PNZ1CLARAVIS (ISOTRETINOIN) CAPSULE [BARR LABORATORIES, INC.]8
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933CLARAVIS (ISOTRETINOIN) CAPSULE [BARR LABORATORIES, INC.]8
AMMONIAINACTIVE INGREDIENT5138Q19F1XCLARAVIS (ISOTRETINOIN) CAPSULE [BARR LABORATORIES, INC.]8
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2UCLARAVIS (ISOTRETINOIN) CAPSULE [BARR LABORATORIES, INC.]8
COTTONSEED OILINACTIVE INGREDIENTH3E878020NCLARAVIS (ISOTRETINOIN) CAPSULE [BARR LABORATORIES, INC.]8
D&C RED NO. 7INACTIVE INGREDIENTECW0LZ41X8CLARAVIS (ISOTRETINOIN) CAPSULE [BARR LABORATORIES, INC.]8
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCLARAVIS (ISOTRETINOIN) CAPSULE [BARR LABORATORIES, INC.]8
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OCLARAVIS (ISOTRETINOIN) CAPSULE [BARR LABORATORIES, INC.]8
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KCLARAVIS (ISOTRETINOIN) CAPSULE [BARR LABORATORIES, INC.]8
ETHYLENE GLYCOL MONOETHYL ETHERINACTIVE INGREDIENTIDK7C2HS09CLARAVIS (ISOTRETINOIN) CAPSULE [BARR LABORATORIES, INC.]8
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCLARAVIS (ISOTRETINOIN) CAPSULE [BARR LABORATORIES, INC.]8
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKCLARAVIS (ISOTRETINOIN) CAPSULE [BARR LABORATORIES, INC.]8
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACLARAVIS (ISOTRETINOIN) CAPSULE [BARR LABORATORIES, INC.]8
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CLARAVIS (ISOTRETINOIN) CAPSULE [BARR LABORATORIES, INC.]8
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675CLARAVIS (ISOTRETINOIN) CAPSULE [BARR LABORATORIES, INC.]8
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTCLARAVIS (ISOTRETINOIN) CAPSULE [BARR LABORATORIES, INC.]8
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357CLARAVIS (ISOTRETINOIN) CAPSULE [BARR LABORATORIES, INC.]8
GELATININACTIVE INGREDIENT2G86QN327LCLARAVIS (ISOTRETINOIN) CAPSULE [BARR LABORATORIES, INC.]8
INDIGOTINDISULFONATE SODIUMINACTIVE INGREDIENTD3741U8K7LCLARAVIS (ISOTRETINOIN) CAPSULE [BARR LABORATORIES, INC.]8
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HCLARAVIS (ISOTRETINOIN) CAPSULE [BARR LABORATORIES, INC.]8
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CLARAVIS (ISOTRETINOIN) CAPSULE [BARR LABORATORIES, INC.]8
SHELLACINACTIVE INGREDIENT46N107B71OCLARAVIS (ISOTRETINOIN) CAPSULE [BARR LABORATORIES, INC.]8
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CLARAVIS (ISOTRETINOIN) CAPSULE [BARR LABORATORIES, INC.]8
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCLARAVIS (ISOTRETINOIN) CAPSULE [BARR LABORATORIES, INC.]8
SOYBEAN OILINACTIVE INGREDIENT241ATL177ACLARAVIS (ISOTRETINOIN) CAPSULE [BARR LABORATORIES, INC.]8
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCLARAVIS (ISOTRETINOIN) CAPSULE [BARR LABORATORIES, INC.]8
WHITE WAXINACTIVE INGREDIENT7G1J5DA97FCLARAVIS (ISOTRETINOIN) CAPSULE [BARR LABORATORIES, INC.]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0555-1054CLARAVIS (ISOTRETINOIN) CAPSULE, LIQUID FILLED [TEVA PHARMACEUTICALS USA, INC.]18Current NDC, Legacy NDC, 3 package rows20220908_a31fd109-d0fd-4ab9-ba98-a3d64333c18d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
404059Claravis 10 MG Oral CapsulePSNa31fd109-d0fd-4ab9-ba98-a3d64333c18d18
404062Claravis 20 MG Oral CapsulePSNa31fd109-d0fd-4ab9-ba98-a3d64333c18d18
643488Claravis 30 MG Oral CapsulePSNa31fd109-d0fd-4ab9-ba98-a3d64333c18d18
404065Claravis 40 MG Oral CapsulePSNa31fd109-d0fd-4ab9-ba98-a3d64333c18d18
197843ISOtretinoin 10 MG Oral CapsulePSNa31fd109-d0fd-4ab9-ba98-a3d64333c18d18
197844ISOtretinoin 20 MG Oral CapsulePSNa31fd109-d0fd-4ab9-ba98-a3d64333c18d18
403930ISOtretinoin 30 MG Oral CapsulePSNa31fd109-d0fd-4ab9-ba98-a3d64333c18d18
197845ISOtretinoin 40 MG Oral CapsulePSNa31fd109-d0fd-4ab9-ba98-a3d64333c18d18
404059isotretinoin 10 MG Oral Capsule [Claravis]SBDa31fd109-d0fd-4ab9-ba98-a3d64333c18d18
404062isotretinoin 20 MG Oral Capsule [Claravis]SBDa31fd109-d0fd-4ab9-ba98-a3d64333c18d18
643488isotretinoin 30 MG Oral Capsule [Claravis]SBDa31fd109-d0fd-4ab9-ba98-a3d64333c18d18
404065isotretinoin 40 MG Oral Capsule [Claravis]SBDa31fd109-d0fd-4ab9-ba98-a3d64333c18d18
197843isotretinoin 10 MG Oral CapsuleSCDa31fd109-d0fd-4ab9-ba98-a3d64333c18d18
197844isotretinoin 20 MG Oral CapsuleSCDa31fd109-d0fd-4ab9-ba98-a3d64333c18d18
403930isotretinoin 30 MG Oral CapsuleSCDa31fd109-d0fd-4ab9-ba98-a3d64333c18d18
197845isotretinoin 40 MG Oral CapsuleSCDa31fd109-d0fd-4ab9-ba98-a3d64333c18d18
404059Claravis 10 MG Oral CapsuleSYa31fd109-d0fd-4ab9-ba98-a3d64333c18d18
404062Claravis 20 MG Oral CapsuleSYa31fd109-d0fd-4ab9-ba98-a3d64333c18d18
643488Claravis 30 MG Oral CapsuleSYa31fd109-d0fd-4ab9-ba98-a3d64333c18d18
404065Claravis 40 MG Oral CapsuleSYa31fd109-d0fd-4ab9-ba98-a3d64333c18d18

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0555-1054-560055510545610 BLISTER PACK in 1 CARTON (0555-1054-56) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0555-1054-60) 10 blister pack2003-05-090000-00-00NoNoCurrent
0555-1054-600055510546010 in 1 BLISTER PACKHistorical
0555-1054-86005551054863 BLISTER PACK in 1 CARTON (0555-1054-86) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0555-1054-60) 3 blister pack2003-05-090000-00-00NoNoCurrent