Home NDC 42023-259 LEUPROLIDE ACETATE
Product NDC 42023-259
11-digit product format 420230259
Labeler code 42023
Product ID 42023-259_6d6d8948-a606-4928-a013-e56a24ac32d7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name LEUPROLIDE ACETATE
Dosage form INJECTION
Route SUBCUTANEOUS
Labeler Endo USA, Inc.
Application ANDA217437
Marketing category ANDA
Marketing start 2026-06-30
Substance LEUPROLIDE ACETATE
Active strength 1 mg/.2mL
Pharmacologic classes Gonadotropin Releasing Hormone Receptor Agonist [EPC], Gonadotropin Releasing Hormone Receptor Agonists [MoA]
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 43 .
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 A217437-001 LEUPROLIDE ACETATE LEUPROLIDE ACETATE 14MG/2.8ML (1MG/0.2ML) SOLUTION / SUBCUTANEOUS 2025-06-09
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 2026-09-14 22:38:34 2026-08 A217437-001 LEUPROLIDE ACETATE 14MG/2.8ML (1MG/0.2ML) SOLUTION / SUBCUTANEOUS 2025-06-09 84e616aacf4f…2026-08-18 06:07:40 2026-07 A217437-001 LEUPROLIDE ACETATE 14MG/2.8ML (1MG/0.2ML) SOLUTION / SUBCUTANEOUS 2025-06-09 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A217437-001 LEUPROLIDE ACETATE 14MG/2.8ML (1MG/0.2ML) SOLUTION / SUBCUTANEOUS 2025-06-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217437-001 LEUPROLIDE ACETATE 14MG/2.8ML (1MG/0.2ML) SOLUTION / SUBCUTANEOUS 2025-06-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217437-001 LEUPROLIDE ACETATE 14MG/2.8ML (1MG/0.2ML) SOLUTION / SUBCUTANEOUS AP 2025-06-09 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217437-001 LEUPROLIDE ACETATE 14MG/2.8ML (1MG/0.2ML) SOLUTION / SUBCUTANEOUS 2025-06-09 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2025-08-23 18:47 UTC 2025-08 A217437-001 AP 1 6a471c1ec25d…
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 LEUPROLIDE ACETATE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LEUPROLIDE ACETATE 1 mg/.2mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 37JNS02E7V Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 545835 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 42023-259-00 42023025900 1 CARTON in 1 KIT (42023-259-00) / 1 VIAL, MULTI-DOSE in 1 CARTON (42023-259-01) / 2.8 mL in 1 VIAL, MULTI-DOSE 1 carton 2026-06-30 No No Current