Vantas

Product NDC
67979-500
11-digit product format
679790500
Labeler code
67979
Product ID
67979-500_f22212f4-3bbb-4201-801b-2667f90610d2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
histrelin acetate
Dosage form
IMPLANT
Route
SUBCUTANEOUS
Labeler
Endo Pharmaceuticals Inc.
Application
NDA021732
Marketing category
NDA
Marketing start
2004-11-01
Marketing end
2022-03-31
Substance
HISTRELIN ACETATE
Active strength
50 mg/1
Pharmacologic classes
Gonadotropin Releasing Hormone Receptor Agonist [EPC],Gonadotropin Releasing Hormone Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

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

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct67979-500DDiscontinued by firm2026-08-03
excluded packagepackage67979-50067979-500-01DDiscontinued by firm2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage67979-500-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67979-500-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67979-500-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67979-500-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage67979-500-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage67979-500-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage67979-500-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage67979-500-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage67979-500-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage67979-500-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage67979-500-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage67979-500-01557ba5c1ecfa…9c80585c8c6e…

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
N021732-001VANTASHISTRELIN ACETATE50MGIMPLANT / SUBCUTANEOUSRLD2004-10-12

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N021732-001VANTAS50MGIMPLANT / SUBCUTANEOUSRLD2004-10-12011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021732-001VANTAS50MGIMPLANT / SUBCUTANEOUSRLD2004-10-1231067a03dcf5…
2025-08-23 18:47 UTC2025-08N021732-001VANTAS50MGIMPLANT / SUBCUTANEOUSRLD2004-10-126a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021732-001VANTAS50MGIMPLANT / SUBCUTANEOUSRLD2004-10-12fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021732-001VANTAS50MGIMPLANT / SUBCUTANEOUSRLD2004-10-12b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021732-001VANTAS50MGIMPLANT / SUBCUTANEOUSRLD2004-10-1203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021732-001VANTAS50MGIMPLANT / SUBCUTANEOUSRLD2004-10-122680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021732-001VANTAS50MGIMPLANT / SUBCUTANEOUSRLD2004-10-125bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021732-001VANTAS50MGIMPLANT / SUBCUTANEOUSRLD2004-10-12d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021732-001VANTAS50MGIMPLANT / SUBCUTANEOUSRLD2004-10-12d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021732-001VANTAS50MGIMPLANT / SUBCUTANEOUSRLD2004-10-1279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021732-001VANTAS50MGIMPLANT / SUBCUTANEOUSRLD2004-10-12301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021732-001VANTAS50MGIMPLANT / SUBCUTANEOUSRLD2004-10-121e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021732-001VANTAS50MGIMPLANT / SUBCUTANEOUSRLD2004-10-128072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021732-001VANTAS50MGIMPLANT / SUBCUTANEOUSRLD2004-10-125c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021732-001VANTAS50MGIMPLANT / SUBCUTANEOUSRLD2004-10-125d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021732-001VANTAS50MGIMPLANT / SUBCUTANEOUSRLD2004-10-124b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021732-001VANTAS50MGIMPLANT / SUBCUTANEOUSRLD, RS2004-10-1274a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021732-001VANTAS50MGIMPLANT / SUBCUTANEOUSRLD2004-10-12bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021732-001VANTAS50MGIMPLANT / SUBCUTANEOUSRLD2004-10-12782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021732-001VANTAS50MGIMPLANT / SUBCUTANEOUSRLD, RS2004-10-1287673890dc5c…
2021-03-12 10:30 UTC2021-03N021732-001VANTAS50MGIMPLANT / SUBCUTANEOUSRLD, RS2004-10-125aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021732-001VANTAS50MGIMPLANT / SUBCUTANEOUSRLD, RS2004-10-128869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021732-001VANTAS50MGIMPLANT / SUBCUTANEOUSRLD, RS2004-10-12c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021732-001VANTAS50MGIMPLANT / SUBCUTANEOUSRLD, RS2004-10-123f01610625f2…
2019-09-15 20:21 UTC2019-09N021732-001VANTAS50MGIMPLANT / SUBCUTANEOUSRLD, RS2004-10-12b00525d2431f…
2019-07-19 19:46 UTC2019-07N021732-001VANTAS50MGIMPLANT / SUBCUTANEOUSRLD, RS2004-10-12ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021732-001VANTAS50MGIMPLANT / SUBCUTANEOUSRLD2004-10-126a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N021732-001VANTAS50MGIMPLANT / SUBCUTANEOUSRLD2004-10-121c564ffb4f44…
2023-12-20 04:57 UTC2023-12N021732-001VANTAS50MGIMPLANT / SUBCUTANEOUSRLD2004-10-12ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021732-001VANTAS50MGIMPLANT / SUBCUTANEOUSRLD2004-10-12a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N021732-001VANTAS50MGIMPLANT / SUBCUTANEOUSRLD2004-10-129b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N021732-001VANTAS50MGIMPLANT / SUBCUTANEOUSRLD2004-10-12a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N021732-001VANTAS50MGIMPLANT / SUBCUTANEOUSRLD2004-10-123f0d92c62455…
2023-05-13 08:27 UTC2023-05N021732-001VANTAS50MGIMPLANT / SUBCUTANEOUSRLD2004-10-12053a50430f4f…
2023-01-26 05:58 UTC2023-01N021732-001VANTAS50MGIMPLANT / SUBCUTANEOUSRLD2004-10-123bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021732-001VANTAS50MGIMPLANT / SUBCUTANEOUSRLD2004-10-123a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N021732-001VANTAS50MGIMPLANT / SUBCUTANEOUSRLD2004-10-12f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N021732-001VANTAS50MGIMPLANT / SUBCUTANEOUSRLD2004-10-12e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N021732-001VANTAS50MGIMPLANT / SUBCUTANEOUSRLD2004-10-12cb3db0bc1861…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67979-500-01EA - Each67979-500b496dea8-5da8-46c2-8e66-8d02b44f421112012-07-24

DailyMed Socrata Ingredients#

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67979-500-01679790500011 VIAL, GLASS in 1 CARTON (67979-500-01) > 1 IMPLANT in 1 VIAL, GLASS2004-11-010000-00-00NoNoCurrent