FDA.reportPublic FDA data

ANAFRANIL

Product NDC
0406-9907
11-digit product format
004069907
Labeler code
0406
Product ID
0406-9907_07af3867-7f3e-4e1c-8100-ad276cb6185f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clomipramine hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
SpecGx LLC
Application
NDA019906
Marketing category
NDA
Marketing start
1989-12-29
Substance
CLOMIPRAMINE HYDROCHLORIDE
Active strength
50 mg/1
Pharmacologic classes
Tricyclic Antidepressant [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLOMIPRAMINE HYDROCHLORIDE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2LXW0L6GWJ
Rxcui857297, 857299, 857301, 857303, 857305, 857307

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
06ad84c7-ef7f-2b11-27cb-22ae93f433b6Product name920240422

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0406-9907-03ANAFRANIL30 in 1 BOTTLECAPSULE3022

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0406-9907-03EA - Each0406-99076b5b21b8-263f-44f7-abff-4a4117374a1f12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CLOMIPRAMINE HYDROCHLORIDEACTIVE INGREDIENT2LXW0L6GWJANAFRANIL (CLOMIPRAMINE HYDROCHLORIDE) CAPSULE [MALLINCKRODT, INC.]11
CLOMIPRAMINEACTIVE MOIETYNUV44L116DANAFRANIL (CLOMIPRAMINE HYDROCHLORIDE) CAPSULE [MALLINCKRODT, INC.]11
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LANAFRANIL (CLOMIPRAMINE HYDROCHLORIDE) CAPSULE [MALLINCKRODT, INC.]11
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GANAFRANIL (CLOMIPRAMINE HYDROCHLORIDE) CAPSULE [MALLINCKRODT, INC.]11
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDANAFRANIL (CLOMIPRAMINE HYDROCHLORIDE) CAPSULE [MALLINCKRODT, INC.]11
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ANAFRANIL (CLOMIPRAMINE HYDROCHLORIDE) CAPSULE [MALLINCKRODT, INC.]11
GELATININACTIVE INGREDIENT2G86QN327LANAFRANIL (CLOMIPRAMINE HYDROCHLORIDE) CAPSULE [MALLINCKRODT, INC.]11
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ANAFRANIL (CLOMIPRAMINE HYDROCHLORIDE) CAPSULE [MALLINCKRODT, INC.]11
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TANAFRANIL (CLOMIPRAMINE HYDROCHLORIDE) CAPSULE [MALLINCKRODT, INC.]11
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHANAFRANIL (CLOMIPRAMINE HYDROCHLORIDE) CAPSULE [MALLINCKRODT, INC.]11
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJANAFRANIL (CLOMIPRAMINE HYDROCHLORIDE) CAPSULE [MALLINCKRODT, INC.]11
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPANAFRANIL (CLOMIPRAMINE HYDROCHLORIDE) CAPSULE [MALLINCKRODT, INC.]11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0406-9907ANAFRANIL (CLOMIPRAMINE HYDROCHLORIDE) CAPSULE [SPECGX LLC]22Current NDC, Legacy NDC, 1 package rows20241204_4074b555-7635-41a9-809d-fae3b3610059.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857299Anafranil 25 MG Oral CapsulePSN4074b555-7635-41a9-809d-fae3b361005922
857303Anafranil 50 MG Oral CapsulePSN4074b555-7635-41a9-809d-fae3b361005922
857307Anafranil 75 MG Oral CapsulePSN4074b555-7635-41a9-809d-fae3b361005922
857297clomiPRAMINE HCl 25 MG Oral CapsulePSN4074b555-7635-41a9-809d-fae3b361005922
857301clomiPRAMINE HCl 50 MG Oral CapsulePSN4074b555-7635-41a9-809d-fae3b361005922
857305clomiPRAMINE HCl 75 MG Oral CapsulePSN4074b555-7635-41a9-809d-fae3b361005922
857299clomipramine hydrochloride 25 MG Oral Capsule [Anafranil]SBD4074b555-7635-41a9-809d-fae3b361005922
857303clomipramine hydrochloride 50 MG Oral Capsule [Anafranil]SBD4074b555-7635-41a9-809d-fae3b361005922
857307clomipramine hydrochloride 75 MG Oral Capsule [Anafranil]SBD4074b555-7635-41a9-809d-fae3b361005922
857297clomipramine hydrochloride 25 MG Oral CapsuleSCD4074b555-7635-41a9-809d-fae3b361005922
857301clomipramine hydrochloride 50 MG Oral CapsuleSCD4074b555-7635-41a9-809d-fae3b361005922
857305clomipramine hydrochloride 75 MG Oral CapsuleSCD4074b555-7635-41a9-809d-fae3b361005922
857299Anafranil 25 MG Oral CapsuleSY4074b555-7635-41a9-809d-fae3b361005922
857303Anafranil 50 MG Oral CapsuleSY4074b555-7635-41a9-809d-fae3b361005922
857307Anafranil 75 MG Oral CapsuleSY4074b555-7635-41a9-809d-fae3b361005922

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0406-9907-030040699070330 CAPSULE in 1 BOTTLE (0406-9907-03) 30 capsule1989-12-290000-00-00NoNoCurrent