FDA.reportPublic FDA data

Striant

Product NDC
52244-030
11-digit product format
522440030
Labeler code
52244
Product ID
52244-030_e7fcb379-2173-46f5-860b-fa461e16e211
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
testosterone
Dosage form
TABLET
Route
BUCCAL
Labeler
Endo Pharmaceuticals Inc.
Application
NDA021543
Marketing category
NDA
Marketing start
2003-06-19
Marketing end
2020-05-31
Substance
TESTOSTERONE
Active strength
30 mg/1
Pharmacologic classes
Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [CS]
DEA schedule
CIII
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct52244-030DDiscontinued by firm2026-07-31
excluded packagepackage52244-03052244-030-60DDiscontinued by firm2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021543-001STRIANTTESTOSTERONE30MGTABLET, EXTENDED RELEASE / BUCCALRLD2003-06-19

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N021543-001STRIANT30MGTABLET, EXTENDED RELEASE / BUCCALRLD2003-06-19a50c72e98297…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52244-030-60EA - Each52244-03038065b96-98f5-4cc2-af4f-6da6b4eb2fdc12013-06-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TESTOSTERONEACTIVE INGREDIENT3XMK78S47OSTRIANT (TESTOSTERONE) TABLET [ACTIENT PHARMACEUTICALS, LLC]6
TESTOSTERONEACTIVE MOIETY3XMK78S47OSTRIANT (TESTOSTERONE) TABLET [ACTIENT PHARMACEUTICALS, LLC]6