FDA.reportPublic FDA data

Striant

Product NDC
55056-3060
11-digit product format
550563060
Labeler code
55056
Product ID
55056-3060_b6cd73a8-8abb-4be4-9174-7215c1096287
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
testosterone
Dosage form
TABLET
Route
BUCCAL
Labeler
Columbia Laboratories, Inc.
Application
NDA021543
Marketing category
NDA
Marketing start
2003-06-19
Marketing end
0000-00-00
Substance
TESTOSTERONE
Active strength
30 mg/1
Pharmacologic classes
Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [CS]
DEA schedule
CIII
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2db4fc38-a116-b0ab-3dae-57df54e5f212Product name220250121
386d1b2a-e9b7-0c83-111f-2a77b92895b3Product name520240422
7d55b53c-798b-47ae-992b-3921493a8303Product name120230322
8d753fd6-75b2-4f12-bcbf-339392960afaProduct name120230303
4fbda828-a5be-46fe-83ec-a88da4359919Product name120230104
93cc9bee-8bdc-273d-ec7f-c2c52535317aProduct name720210902
a6389cd1-36d1-4b5c-9934-1139bee93605Product name520210601
f4f0889f-ee8b-471f-9a37-02a035280637Product name120200122
09e1afd3-f431-4380-82c5-438884c25615Product name120190111
a6389cd1-36d1-4b5c-9934-1139bee93605Product name320171212
502efed8-01a5-ef6a-61c6-fe8302b6e26bProduct name220171113
8b700cfd-17dd-41a2-90f5-a80ae8a989a2Product name120171113
9ce0e503-4ae7-2c6a-39ae-85285c29db68Product name220171113
96bdf4b3-71cd-433d-9723-89e50f852992Product name120150810
ed2e617f-f28a-1df1-f9fc-c79702f31271Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55056-3060-12019-10-21C16284748780-1956f9ecf-c2a3-621f-e053-dbdaa90a74adSTRIANT ® (testosterone buccal system) mucoadhesive

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55056-3060-1Striant10 in 1 BLISTER PACKTABLET102
55056-3060-1Striant6 in 1 CARTONTABLET62

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55056-3060-1EA - Each55056-306058fde447-f115-4864-8c20-3724926f10b512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
testosteroneACTIVE INGREDIENT3XMK78S47OSTRIANT (TESTOSTERONE) TABLET [COLUMBIA LABORATORIES, INC.]2
testosteroneACTIVE MOIETY3XMK78S47OSTRIANT (TESTOSTERONE) TABLET [COLUMBIA LABORATORIES, INC.]2
anhydrous lactoseINACTIVE INGREDIENT3SY5LH9PMKSTRIANT (TESTOSTERONE) TABLET [COLUMBIA LABORATORIES, INC.]2
carbomer 934INACTIVE INGREDIENTZ135WT9208STRIANT (TESTOSTERONE) TABLET [COLUMBIA LABORATORIES, INC.]2
hypromelloseINACTIVE INGREDIENT3NXW29V3WOSTRIANT (TESTOSTERONE) TABLET [COLUMBIA LABORATORIES, INC.]2
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XSTRIANT (TESTOSTERONE) TABLET [COLUMBIA LABORATORIES, INC.]2
magnesium stearateINACTIVE INGREDIENT70097M6I30STRIANT (TESTOSTERONE) TABLET [COLUMBIA LABORATORIES, INC.]2
polycarbophilINACTIVE INGREDIENTW25LM17A4WSTRIANT (TESTOSTERONE) TABLET [COLUMBIA LABORATORIES, INC.]2
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4STRIANT (TESTOSTERONE) TABLET [COLUMBIA LABORATORIES, INC.]2
starch, cornINACTIVE INGREDIENTO8232NY3SJSTRIANT (TESTOSTERONE) TABLET [COLUMBIA LABORATORIES, INC.]2
talcINACTIVE INGREDIENT7SEV7J4R1USTRIANT (TESTOSTERONE) TABLET [COLUMBIA LABORATORIES, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55056-3060STRIANT (TESTOSTERONE) TABLET [COLUMBIA LABORATORIES, INC.]2Legacy NDC, 2 package rows20091214_ac47efbe-025b-4688-bcd3-a10a0b012b34.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
858108STRIANT 30 MG Buccal Film, MucoadhesivePSNac47efbe-025b-4688-bcd3-a10a0b012b342
858106testosterone 30 MG Buccal Film, MucoadhesivePSNac47efbe-025b-4688-bcd3-a10a0b012b342
858108testosterone 30 MG Buccal Film [Striant]SBDac47efbe-025b-4688-bcd3-a10a0b012b342
858106testosterone 30 MG Buccal FilmSCDac47efbe-025b-4688-bcd3-a10a0b012b342
858108Striant 30 MG Buccal FilmSYac47efbe-025b-4688-bcd3-a10a0b012b342

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
55056-3060-15505630600110 in 1 BLISTER PACKHistorical