TRIPTODUR

Product NDC
24338-150
11-digit product format
243380150
Labeler code
24338
Product ID
24338-150_1c06d8b5-edbc-4de7-a423-7588069d3c38
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
triptorelin
Dosage form
KIT
Labeler
Azurity Pharmaceuticals, Inc.
Application
NDA208956
Marketing category
NDA
Marketing start
2017-09-08
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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
N208956-001TRIPTODUR KITTRIPTORELIN PAMOATEEQ 22.5MG BASE/VIALFOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULARRLD, RS2017-06-29

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N208956-001101661812029-06-30Drug product2019-01-25

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 22:54:322026-06N208956-001TRIPTODUR KITEQ 22.5MG BASE/VIALFOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULARRLD, RS2017-06-29a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-01 22:54:322026-06N208956-001101661812029-06-30Drug product2019-01-25a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TRIPTODURTRIPTORELINAzurity Pharmaceuticals, Inc.f41380e7-b830-432d-a5f5-a872932f107e2025-09-14Warnings, Adverse reactionsExact identifier
application applno (NDA): 208956
application number: NDA208956
ndc (product): 24338-150

Additional Listing Data#

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
905053Internal RxNorm lookup
1944389Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
f41380e7-b830-432d-a5f5-a872932f107eAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9337e4c8-b17a-4e1a-88bb-852b6525db5cProduct name120170810

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
24338-150-20TRIPTODUR1 in 1 CARTONKIT116

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24338-150-20EA - Each24338-1507f867bc6-8b99-4fd9-b4ba-bfb6debdc85912017-09-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24338-150TRIPTODUR (TRIPTORELIN) KIT [AZURITY PHARMACEUTICALS, INC.]15Current NDC, Legacy NDC, 1 package rows20240511_f41380e7-b830-432d-a5f5-a872932f107e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1944389Triptodur 22.5 MG InjectionPSNf41380e7-b830-432d-a5f5-a872932f107e16
905053triptorelin 22.5 MG InjectionPSNf41380e7-b830-432d-a5f5-a872932f107e16
1944389triptorelin 22.5 MG Injection [Triptodur]SBDf41380e7-b830-432d-a5f5-a872932f107e16
905053triptorelin 22.5 MG InjectionSCDf41380e7-b830-432d-a5f5-a872932f107e16
1944389Triptodur 22.5 MG InjectionSYf41380e7-b830-432d-a5f5-a872932f107e16
905053triptorelin pamoate 22.5 MG InjectionSYf41380e7-b830-432d-a5f5-a872932f107e16

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
24338-150-20243380150201 KIT in 1 CARTON (24338-150-20) * 2 mL in 1 VIAL * 2 mL in 1 SYRINGE, GLASS1 kit2017-09-080000-00-00NoNoCurrent