Home NDC 72851-100 CAMCEVI ETM
Product NDC 72851-100
11-digit product format 728510100
Labeler code 72851
Product ID 72851-100_14ea9819-02e5-446c-95c0-1b6133521112
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name leuprolide
Dosage form INJECTION, EMULSION
Route SUBCUTANEOUS
Labeler Foresee Pharmaceuticals Co., Ltd.
Application NDA219745
Marketing category NDA
Marketing start 2026-10-31
Substance LEUPROLIDE MESYLATE
Active strength 21 mg/.3g
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 44 .
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 N219745-001 CAMCEVI ETM LEUPROLIDE MESYLATE EQ 21MG BASE EMULSION / SUBCUTANEOUS RLD, RS 2025-08-25
Orange Book patents# Current patent rows page 1 of 1 · 5 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N219745-001 10646572 2027-01-16 Drug product 2026-06-03 N219745-001 9744207 2027-01-16 Drug product 2026-06-03 N219745-001 9572857 2029-08-02 Drug product 2026-06-03 N219745-001 12133878 2037-12-18 Drug product 2026-06-03 N219745-001 11717555 2039-01-01 Drug product 2026-06-03
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N219745-001 NS 2028-08-25
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-10-15 13:18:30 2026-09 N219745-001 CAMCEVI ETM EQ 21MG BASE EMULSION / SUBCUTANEOUS RLD, RS 2025-08-25 c2088c7a36db…2026-09-14 22:38:34 2026-08 N219745-001 CAMCEVI ETM EQ 21MG BASE EMULSION / SUBCUTANEOUS RLD, RS 2025-08-25 84e616aacf4f…2026-08-18 06:07:40 2026-07 N219745-001 CAMCEVI ETM EQ 21MG BASE EMULSION / SUBCUTANEOUS RLD, RS 2025-08-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N219745-001 CAMCEVI ETM EQ 21MG BASE EMULSION / SUBCUTANEOUS RLD, RS 2025-08-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N219745-001 CAMCEVI ETM EQ 21MG BASE EMULSION / SUBCUTANEOUS RLD, RS 2025-08-25 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219745-001 CAMCEVI ETM EQ 21MG BASE EMULSION / SUBCUTANEOUS RLD, RS 2025-08-25 a50c72e98297…
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-10-15 13:18:30 2026-09 N219745-001 10646572 2027-01-16 Drug product 2026-06-03 c2088c7a36db…2026-10-15 13:18:30 2026-09 N219745-001 9744207 2027-01-16 Drug product 2026-06-03 c2088c7a36db…2026-10-15 13:18:30 2026-09 N219745-001 9572857 2029-08-02 Drug product 2026-06-03 c2088c7a36db…2026-10-15 13:18:30 2026-09 N219745-001 12133878 2037-12-18 Drug product 2026-06-03 c2088c7a36db…2026-10-15 13:18:30 2026-09 N219745-001 11717555 2039-01-01 Drug product 2026-06-03 c2088c7a36db…2026-09-14 22:38:34 2026-08 N219745-001 10646572 2027-01-16 Drug product 2026-06-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219745-001 9744207 2027-01-16 Drug product 2026-06-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219745-001 9572857 2029-08-02 Drug product 2026-06-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219745-001 12133878 2037-12-18 Drug product 2026-06-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219745-001 11717555 2039-01-01 Drug product 2026-06-03 84e616aacf4f…2026-08-18 06:07:40 2026-07 N219745-001 10646572 2027-01-16 Drug product 2026-06-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N219745-001 9744207 2027-01-16 Drug product 2026-06-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N219745-001 9572857 2029-08-02 Drug product 2026-06-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N219745-001 12133878 2037-12-18 Drug product 2026-06-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N219745-001 11717555 2039-01-01 Drug product 2026-06-03 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219745-001 10646572 2027-01-16 Drug product 2026-06-03 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219745-001 9744207 2027-01-16 Drug product 2026-06-03 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219745-001 9572857 2029-08-02 Drug product 2026-06-03 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219745-001 12133878 2037-12-18 Drug product 2026-06-03 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219745-001 11717555 2039-01-01 Drug product 2026-06-03 a50c72e98297…
Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2026-10-15 13:18:30 2026-09 N219745-001 NS 2028-08-25 c2088c7a36db…2026-09-14 22:38:34 2026-08 N219745-001 NS 2028-08-25 84e616aacf4f…2026-08-18 06:07:40 2026-07 N219745-001 NS 2028-08-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N219745-001 NS 2028-08-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N219745-001 NS 2028-08-25 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219745-001 NS 2028-08-25 a50c72e98297…
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 CAMCEVI ETM
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LEUPROLIDE MESYLATE 21 mg/.3g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 8E3C3C493W Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers 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 72851-100-01 72851010001 1 SYRINGE in 1 CARTON (72851-100-01) / .3 g in 1 SYRINGE 1 syringe 2026-10-31 No No Current