Home NDC 55056-3060 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 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021543-001 STRIANT TESTOSTERONE 30MG TABLET, EXTENDED RELEASE / BUCCAL RLD 2003-06-19
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 N021543-001 STRIANT 30MG TABLET, EXTENDED RELEASE / BUCCAL RLD 2003-06-19 a50c72e98297…
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 55056-3060-1 Striant 10 in 1 BLISTER PACK TABLET 10 2 55056-3060-1 Striant 6 in 1 CARTON TABLET 6 2
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded testosterone ACTIVE INGREDIENT 3XMK78S47O STRIANT (TESTOSTERONE) TABLET [COLUMBIA LABORATORIES, INC.] 2 testosterone ACTIVE MOIETY 3XMK78S47O STRIANT (TESTOSTERONE) TABLET [COLUMBIA LABORATORIES, INC.] 2 anhydrous lactose INACTIVE INGREDIENT 3SY5LH9PMK STRIANT (TESTOSTERONE) TABLET [COLUMBIA LABORATORIES, INC.] 2 carbomer 934 INACTIVE INGREDIENT Z135WT9208 STRIANT (TESTOSTERONE) TABLET [COLUMBIA LABORATORIES, INC.] 2 hypromellose INACTIVE INGREDIENT 3NXW29V3WO STRIANT (TESTOSTERONE) TABLET [COLUMBIA LABORATORIES, INC.] 2 lactose monohydrate INACTIVE INGREDIENT EWQ57Q8I5X STRIANT (TESTOSTERONE) TABLET [COLUMBIA LABORATORIES, INC.] 2 magnesium stearate INACTIVE INGREDIENT 70097M6I30 STRIANT (TESTOSTERONE) TABLET [COLUMBIA LABORATORIES, INC.] 2 polycarbophil INACTIVE INGREDIENT W25LM17A4W STRIANT (TESTOSTERONE) TABLET [COLUMBIA LABORATORIES, INC.] 2 silicon dioxide INACTIVE INGREDIENT ETJ7Z6XBU4 STRIANT (TESTOSTERONE) TABLET [COLUMBIA LABORATORIES, INC.] 2 starch, corn INACTIVE INGREDIENT O8232NY3SJ STRIANT (TESTOSTERONE) TABLET [COLUMBIA LABORATORIES, INC.] 2 talc INACTIVE INGREDIENT 7SEV7J4R1U STRIANT (TESTOSTERONE) TABLET [COLUMBIA LABORATORIES, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55056-3060 STRIANT (TESTOSTERONE) TABLET [COLUMBIA LABORATORIES, INC.] 2 Legacy NDC, 2 package rows 20091214_ac47efbe-025b-4688-bcd3-a10a0b012b34.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 55056-3060-1 55056306001 10 in 1 BLISTER PACK Historical