FDA.reportPublic FDA data

Trifluoperazine Hydrochloride

Product NDC
51079-573
11-digit product format
510790573
Labeler code
51079
Product ID
51079-573_3a877366-459b-cfac-e063-6294a90a6453
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
trifluoperazine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Mylan Institutional Inc.
Application
ANDA040209
Marketing category
ANDA
Marketing start
1998-03-04
Substance
TRIFLUOPERAZINE HYDROCHLORIDE
Active strength
2 mg/1
Pharmacologic classes
Phenothiazine [EPC], Phenothiazines [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRIFLUOPERAZINE HYDROCHLORIDE2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6P1Y2SNF5V
Rxcui198322, 198323, 198324, 198325

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f79ee509-5da6-94e3-5c99-5b799d5c6f47Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51079-573-01Trifluoperazine Hydrochloride1 in 1 BLISTER PACKTABLET, FILM COATED111
51079-573-20Trifluoperazine Hydrochloride100 in 1 CARTONTABLET, FILM COATED10011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51079-573-01EA - Each51079-5732c5731c8-3729-4daf-a678-757fe46b44dd12012-07-24
51079-573-20EA - Each51079-573ec56a0bb-26c5-4da5-bb88-90ccea69f2bb12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TRIFLUOPERAZINE HYDROCHLORIDEACTIVE INGREDIENT6P1Y2SNF5VTRIFLUOPERAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]3
TRIFLUOPERAZINEACTIVE MOIETY214IZI85K3TRIFLUOPERAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTRIFLUOPERAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48TRIFLUOPERAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]3
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BTRIFLUOPERAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]3
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKTRIFLUOPERAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]3
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8TRIFLUOPERAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOTRIFLUOPERAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XTRIFLUOPERAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TRIFLUOPERAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]3
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IETRIFLUOPERAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ATRIFLUOPERAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TRIFLUOPERAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]3
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JTRIFLUOPERAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTRIFLUOPERAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTRIFLUOPERAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]3
TRIACETININACTIVE INGREDIENTXHX3C3X673TRIFLUOPERAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51079-573TRIFLUOPERAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]9Current NDC, Legacy NDC, 2 package rows20241010_f742a579-411a-4140-91c4-edc735d638fa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198322trifluoperazine HCl 1 MG Oral TabletPSNf742a579-411a-4140-91c4-edc735d638fa11
198323trifluoperazine HCl 10 MG Oral TabletPSNf742a579-411a-4140-91c4-edc735d638fa11
198324trifluoperazine HCl 2 MG Oral TabletPSNf742a579-411a-4140-91c4-edc735d638fa11
198325trifluoperazine HCl 5 MG Oral TabletPSNf742a579-411a-4140-91c4-edc735d638fa11
198322trifluoperazine 1 MG Oral TabletSCDf742a579-411a-4140-91c4-edc735d638fa11
198323trifluoperazine 10 MG Oral TabletSCDf742a579-411a-4140-91c4-edc735d638fa11
198324trifluoperazine 2 MG Oral TabletSCDf742a579-411a-4140-91c4-edc735d638fa11
198325trifluoperazine 5 MG Oral TabletSCDf742a579-411a-4140-91c4-edc735d638fa11
198322trifluoperazine (as trifluoperazine hydrochloride) 1 MG Oral TabletSYf742a579-411a-4140-91c4-edc735d638fa11
198323trifluoperazine (as trifluoperazine hydrochloride) 10 MG Oral TabletSYf742a579-411a-4140-91c4-edc735d638fa11
198324trifluoperazine (as trifluoperazine hydrochloride) 2 MG Oral TabletSYf742a579-411a-4140-91c4-edc735d638fa11
198325trifluoperazine (as trifluoperazine hydrochloride) 5 MG Oral TabletSYf742a579-411a-4140-91c4-edc735d638fa11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51079-573-01510790573011 in 1 BLISTER PACKHistorical
51079-573-2051079057320100 BLISTER PACK in 1 CARTON (51079-573-20) / 1 TABLET, FILM COATED in 1 BLISTER PACK (51079-573-01) 100 blister pack1998-03-040000-00-00NoNoCurrent