Trelstar

Product NDC
74676-5904
11-digit product format
746765904
Labeler code
74676
Product ID
74676-5904_ac43d5b2-3223-b955-2798-555d48497798
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
triptorelin pamoate
Dosage form
KIT
Labeler
Verity Pharmaceuticals Inc.
Application
NDA021288
Marketing category
NDA
Marketing start
2001-06-29
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N021288-001TRELSTARTRIPTORELIN PAMOATEEQ 11.25MG BASE/VIALINJECTABLE / INTRAMUSCULARRLD, RS2001-06-29

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.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N021288-001TRELSTAREQ 11.25MG BASE/VIALINJECTABLE / INTRAMUSCULARRLD, RS2001-06-2984e616aacf4f…
2026-08-18 06:07:402026-07N021288-001TRELSTAREQ 11.25MG BASE/VIALINJECTABLE / INTRAMUSCULARRLD, RS2001-06-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021288-001TRELSTAREQ 11.25MG BASE/VIALINJECTABLE / INTRAMUSCULARRLD, RS2001-06-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021288-001TRELSTAREQ 11.25MG BASE/VIALINJECTABLE / INTRAMUSCULARRLD, RS2001-06-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08N021288-001TRELSTAREQ 11.25MG BASE/VIALINJECTABLE / INTRAMUSCULARRLD, RS2001-06-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021288-001TRELSTAREQ 11.25MG BASE/VIALINJECTABLE / INTRAMUSCULARRLD, RS2001-06-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021288-001TRELSTAREQ 11.25MG BASE/VIALINJECTABLE / INTRAMUSCULARRLD, RS2001-06-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021288-001TRELSTAREQ 11.25MG BASE/VIALINJECTABLE / INTRAMUSCULARRLD, RS2001-06-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021288-001TRELSTAREQ 11.25MG BASE/VIALINJECTABLE / INTRAMUSCULARRLD, RS2001-06-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021288-001TRELSTAREQ 11.25MG BASE/VIALINJECTABLE / INTRAMUSCULARRLD, RS2001-06-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021288-001TRELSTAREQ 11.25MG BASE/VIALINJECTABLE / INTRAMUSCULARRLD, RS2001-06-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021288-001TRELSTAREQ 11.25MG BASE/VIALINJECTABLE / INTRAMUSCULARRLD, RS2001-06-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021288-001TRELSTAREQ 11.25MG BASE/VIALINJECTABLE / INTRAMUSCULARRLD, RS2001-06-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021288-001TRELSTAREQ 11.25MG BASE/VIALINJECTABLE / INTRAMUSCULARRLD, RS2001-06-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021288-001TRELSTAREQ 11.25MG BASE/VIALINJECTABLE / INTRAMUSCULARRLD, RS2001-06-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021288-001TRELSTAREQ 11.25MG BASE/VIALINJECTABLE / INTRAMUSCULARRLD, RS2001-06-298072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021288-001TRELSTAREQ 11.25MG BASE/VIALINJECTABLE / INTRAMUSCULARRLD, RS2001-06-295c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021288-001TRELSTAREQ 11.25MG BASE/VIALINJECTABLE / INTRAMUSCULARRLD, RS2001-06-295d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021288-001TRELSTAREQ 11.25MG BASE/VIALINJECTABLE / INTRAMUSCULARRLD, RS2001-06-294b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021288-001TRELSTAREQ 11.25MG BASE/VIALINJECTABLE / INTRAMUSCULARRLD, RS2001-06-2974a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021288-001TRELSTAREQ 11.25MG BASE/VIALINJECTABLE / INTRAMUSCULARRLD, RS2001-06-29bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021288-001TRELSTAREQ 11.25MG BASE/VIALINJECTABLE / INTRAMUSCULARRLD, RS2001-06-29782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021288-001TRELSTAREQ 11.25MG BASE/VIALINJECTABLE / INTRAMUSCULARRLD, RS2001-06-2987673890dc5c…
2021-03-12 10:30 UTC2021-03N021288-001TRELSTAREQ 11.25MG BASE/VIALINJECTABLE / INTRAMUSCULARRLD, RS2001-06-295aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021288-001TRELSTAREQ 11.25MG BASE/VIALINJECTABLE / INTRAMUSCULARRLD, RS2001-06-298869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021288-001TRELSTAREQ 11.25MG BASE/VIALINJECTABLE / INTRAMUSCULARRLD, RS2001-06-29c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021288-001TRELSTAREQ 11.25MG BASE/VIALINJECTABLE / INTRAMUSCULARRLD, RS2001-06-293f01610625f2…
2019-09-15 20:21 UTC2019-09N021288-001TRELSTAREQ 11.25MG BASE/VIALINJECTABLE / INTRAMUSCULARRLD, RS2001-06-29b00525d2431f…
2019-07-19 19:46 UTC2019-07N021288-001TRELSTAREQ 11.25MG BASE/VIALINJECTABLE / INTRAMUSCULARRLD, RS2001-06-29ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021288-001TRELSTAREQ 11.25MG BASE/VIALINJECTABLE / INTRAMUSCULARRLD, RS2001-06-296a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N021288-001TRELSTAREQ 11.25MG BASE/VIALINJECTABLE / INTRAMUSCULARRLD, RS2001-06-291c564ffb4f44…
2023-12-20 04:57 UTC2023-12N021288-001TRELSTAREQ 11.25MG BASE/VIALINJECTABLE / INTRAMUSCULARRLD, RS2001-06-29ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021288-001TRELSTAREQ 11.25MG BASE/VIALINJECTABLE / INTRAMUSCULARRLD, RS2001-06-29a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N021288-001TRELSTAREQ 11.25MG BASE/VIALINJECTABLE / INTRAMUSCULARRLD, RS2001-06-299b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N021288-001TRELSTAREQ 11.25MG BASE/VIALINJECTABLE / INTRAMUSCULARRLD, RS2001-06-29a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N021288-001TRELSTAREQ 11.25MG BASE/VIALINJECTABLE / INTRAMUSCULARRLD, RS2001-06-293f0d92c62455…
2023-05-13 08:27 UTC2023-05N021288-001TRELSTAREQ 11.25MG BASE/VIALINJECTABLE / INTRAMUSCULARRLD, RS2001-06-29053a50430f4f…
2023-01-26 05:58 UTC2023-01N021288-001TRELSTAREQ 11.25MG BASE/VIALINJECTABLE / INTRAMUSCULARRLD, RS2001-06-293bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021288-001TRELSTAREQ 11.25MG BASE/VIALINJECTABLE / INTRAMUSCULARRLD, RS2001-06-293a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N021288-001TRELSTAREQ 11.25MG BASE/VIALINJECTABLE / INTRAMUSCULARRLD, RS2001-06-29f41ea6bd6efb…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Trelstar
Listing expiration
2027-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
199821Internal RxNorm lookup
905053Internal RxNorm lookup
905057Internal RxNorm lookup
905059Internal RxNorm lookup
905062Internal RxNorm lookup
905064Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b1b84d62-a369-a4b7-5c41-dd1f553a18f3Available 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
74676-5904-1Trelstar1 in 1 CARTONKIT118

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74676-5904TRELSTAR (TRIPTORELIN PAMOATE) KIT [VERITY PHARMACEUTICALS INC.]17Current NDC, Legacy NDC, 1 package rows20250327_b1b84d62-a369-a4b7-5c41-dd1f553a18f3.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

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

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TrelstarTRIPTORELIN PAMOATEVerity Pharmaceuticals Inc.b1b84d62-a369-a4b7-5c41-dd1f553a18f32026-06-30Warnings, Adverse reactionsExact identifier
application applno (NDA): 021288
application number: NDA021288
ndc (product): 74676-5904

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
905064Trelstar 11.25 MG InjectionPSNb1b84d62-a369-a4b7-5c41-dd1f553a18f318
905057Trelstar 22.5 MG InjectionPSNb1b84d62-a369-a4b7-5c41-dd1f553a18f318
905059Trelstar 3.75 MG InjectionPSNb1b84d62-a369-a4b7-5c41-dd1f553a18f318
905062triptorelin 11.25 MG InjectionPSNb1b84d62-a369-a4b7-5c41-dd1f553a18f318
905053triptorelin 22.5 MG InjectionPSNb1b84d62-a369-a4b7-5c41-dd1f553a18f318
199821triptorelin 3.75 MG InjectionPSNb1b84d62-a369-a4b7-5c41-dd1f553a18f318
905064triptorelin 11.25 MG Injection [Trelstar]SBDb1b84d62-a369-a4b7-5c41-dd1f553a18f318
905057triptorelin 22.5 MG Injection [Trelstar]SBDb1b84d62-a369-a4b7-5c41-dd1f553a18f318
905059triptorelin 3.75 MG Injection [Trelstar]SBDb1b84d62-a369-a4b7-5c41-dd1f553a18f318
905062triptorelin 11.25 MG InjectionSCDb1b84d62-a369-a4b7-5c41-dd1f553a18f318
905053triptorelin 22.5 MG InjectionSCDb1b84d62-a369-a4b7-5c41-dd1f553a18f318
199821triptorelin 3.75 MG InjectionSCDb1b84d62-a369-a4b7-5c41-dd1f553a18f318
905064Trelstar 11.25 MG InjectionSYb1b84d62-a369-a4b7-5c41-dd1f553a18f318
905057Trelstar 22.5 MG InjectionSYb1b84d62-a369-a4b7-5c41-dd1f553a18f318
905059Trelstar 3.75 MG InjectionSYb1b84d62-a369-a4b7-5c41-dd1f553a18f318
905053triptorelin pamoate 22.5 MG InjectionSYb1b84d62-a369-a4b7-5c41-dd1f553a18f318

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
74676-5904-1746765904011 KIT in 1 CARTON (74676-5904-1) * 2 mL in 1 VIAL, SINGLE-DOSE (74676-5904-0) * 2 mL in 1 SYRINGE1 kit2001-06-290000-00-00NoNoCurrent