FDA.reportPublic FDA data

Thiothixene

Product NDC
70954-015
11-digit product format
709540015
Labeler code
70954
Product ID
70954-015_92792cc3-5d0e-4105-bf5a-03f2e479b8d7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Thiothixene
Dosage form
CAPSULE
Route
ORAL
Labeler
ANI Pharmaceuticals, Inc.
Application
ANDA211642
Marketing category
ANDA
Marketing start
2019-04-05
Substance
THIOTHIXENE
Active strength
2 mg/1
Pharmacologic classes
Typical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
THIOTHIXENE2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7318FJ13YJ
Rxcui313361, 313362, 313364, 313366

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b5299972-3372-4536-b6da-1420f7d91760Product name220221213

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70954-015-10Thiothixene100 in 1 BOTTLECAPSULE1004
70954-015-20Thiothixene1000 in 1 BOTTLECAPSULE10004
70954-015-30Thiothixene1 in 1 BLISTER PACKCAPSULE14
70954-015-40Thiothixene100 in 1 CARTONCAPSULE1004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70954-015-10EA - Each70954-0157cb5778d-5863-4761-9766-328c810d326e12019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70954-015THIOTHIXENE CAPSULE [ANI PHARMACEUTICALS, INC.]4Current NDC, Legacy NDC, 4 package rows20250227_b067b400-66cd-422d-a631-9ce0c935d2b2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313362thiothixene 1 MG Oral CapsulePSN9480a406-c85b-ba06-e053-2a95a90a09125
313361thiothixene 10 MG Oral CapsulePSN9480a406-c85b-ba06-e053-2a95a90a09125
313364thiothixene 2 MG Oral CapsulePSN9480a406-c85b-ba06-e053-2a95a90a09125
313366thiothixene 5 MG Oral CapsulePSN9480a406-c85b-ba06-e053-2a95a90a09125
313362thiothixene 1 MG Oral CapsuleSCD9480a406-c85b-ba06-e053-2a95a90a09125
313361thiothixene 10 MG Oral CapsuleSCD9480a406-c85b-ba06-e053-2a95a90a09125
313364thiothixene 2 MG Oral CapsuleSCD9480a406-c85b-ba06-e053-2a95a90a09125
313366thiothixene 5 MG Oral CapsuleSCD9480a406-c85b-ba06-e053-2a95a90a09125
313362thiothixene 1 MG Oral CapsulePSNb067b400-66cd-422d-a631-9ce0c935d2b24
313361thiothixene 10 MG Oral CapsulePSNb067b400-66cd-422d-a631-9ce0c935d2b24
313364thiothixene 2 MG Oral CapsulePSNb067b400-66cd-422d-a631-9ce0c935d2b24
313366thiothixene 5 MG Oral CapsulePSNb067b400-66cd-422d-a631-9ce0c935d2b24
313362thiothixene 1 MG Oral CapsuleSCDb067b400-66cd-422d-a631-9ce0c935d2b24
313361thiothixene 10 MG Oral CapsuleSCDb067b400-66cd-422d-a631-9ce0c935d2b24
313364thiothixene 2 MG Oral CapsuleSCDb067b400-66cd-422d-a631-9ce0c935d2b24
313366thiothixene 5 MG Oral CapsuleSCDb067b400-66cd-422d-a631-9ce0c935d2b24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70954-015-1070954001510100 CAPSULE in 1 BOTTLE (70954-015-10) 100 capsule2019-04-050000-00-00NoNoCurrent
70954-015-20709540015201000 CAPSULE in 1 BOTTLE (70954-015-20) 1000 capsule2019-04-050000-00-00NoNoCurrent
70954-015-30709540015301 in 1 BLISTER PACKHistorical
70954-015-4070954001540100 BLISTER PACK in 1 CARTON (70954-015-40) / 1 CAPSULE in 1 BLISTER PACK (70954-015-30) 100 blister pack2020-08-280000-00-00NoNoCurrent