Home NDC 69448-023 CAMCEVI
Product NDC 69448-023
11-digit product format 694480023
Labeler code 69448
Product ID 69448-023_4b1ad850-61b1-d516-e063-6394a90aeea8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name LEUPROLIDE
Dosage form INJECTION, EMULSION
Route SUBCUTANEOUS
Labeler Accord BioPharma, Inc.
Application NDA211488
Marketing category NDA
Marketing start 2025-05-19
Substance LEUPROLIDE MESYLATE
Active strength 42 mg/.37g
Pharmacologic classes Gonadotropin Releasing Hormone Receptor Agonist [EPC], Gonadotropin Releasing Hormone Receptor Agonists [MoA]
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 1 .
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 N211488-001 CAMCEVI KIT LEUPROLIDE MESYLATE EQ 42MG BASE EMULSION / SUBCUTANEOUS RLD, RS 2021-05-25
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 N211488-001 10646572 2027-01-16 Drug product 2021-07-15 N211488-001 9744207 2027-01-16 Drug product 2021-07-15 N211488-001 9572857 2029-08-02 Drug product 2021-07-15 N211488-001 12133878 2037-12-18 Drug product 2024-11-12 N211488-001 11717555 2039-01-01 Drug product 2023-08-25
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 2026-02-19 14:30 UTC 2026-02 N211488-001 CAMCEVI KIT EQ 42MG BASE EMULSION / SUBCUTANEOUS RLD, RS 2021-05-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211488-001 CAMCEVI KIT EQ 42MG BASE EMULSION / SUBCUTANEOUS RLD, RS 2021-05-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N211488-001 CAMCEVI KIT EQ 42MG BASE EMULSION / SUBCUTANEOUS RLD, RS 2021-05-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211488-001 CAMCEVI KIT EQ 42MG BASE EMULSION / SUBCUTANEOUS RLD, RS 2021-05-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211488-001 CAMCEVI KIT EQ 42MG BASE EMULSION / SUBCUTANEOUS RLD, RS 2021-05-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N211488-001 CAMCEVI KIT EQ 42MG BASE EMULSION / SUBCUTANEOUS RLD, RS 2021-05-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N211488-001 CAMCEVI KIT EQ 42MG BASE EMULSION / SUBCUTANEOUS RLD, RS 2021-05-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N211488-001 CAMCEVI KIT EQ 42MG BASE EMULSION / SUBCUTANEOUS RLD, RS 2021-05-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N211488-001 CAMCEVI KIT EQ 42MG BASE EMULSION / SUBCUTANEOUS RLD, RS 2021-05-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N211488-001 CAMCEVI KIT EQ 42MG BASE EMULSION / SUBCUTANEOUS RLD, RS 2021-05-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N211488-001 CAMCEVI KIT EQ 42MG BASE EMULSION / SUBCUTANEOUS RLD, RS 2021-05-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N211488-001 CAMCEVI KIT EQ 42MG BASE EMULSION / SUBCUTANEOUS RLD, RS 2021-05-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N211488-001 CAMCEVI KIT EQ 42MG BASE EMULSION / SUBCUTANEOUS RLD, RS 2021-05-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N211488-001 CAMCEVI KIT EQ 42MG BASE EMULSION / SUBCUTANEOUS RLD, RS 2021-05-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N211488-001 CAMCEVI KIT EQ 42MG BASE EMULSION / SUBCUTANEOUS RLD, RS 2021-05-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N211488-001 CAMCEVI KIT EQ 42MG BASE EMULSION / SUBCUTANEOUS RLD, RS 2021-05-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N211488-001 CAMCEVI KIT EQ 42MG BASE EMULSION / SUBCUTANEOUS RLD, RS 2021-05-25 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N211488-001 CAMCEVI KIT EQ 42MG BASE EMULSION / SUBCUTANEOUS RLD, RS 2021-05-25 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N211488-001 CAMCEVI KIT EQ 42MG BASE EMULSION / SUBCUTANEOUS RLD, RS 2021-05-25 782e0a99824c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N211488-001 CAMCEVI KIT EQ 42MG BASE EMULSION / SUBCUTANEOUS RLD, RS 2021-05-25 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N211488-001 CAMCEVI KIT EQ 42MG BASE EMULSION / SUBCUTANEOUS RLD, RS 2021-05-25 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N211488-001 CAMCEVI KIT EQ 42MG BASE EMULSION / SUBCUTANEOUS RLD, RS 2021-05-25 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N211488-001 CAMCEVI KIT EQ 42MG BASE EMULSION / SUBCUTANEOUS RLD, RS 2021-05-25 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N211488-001 CAMCEVI KIT EQ 42MG BASE EMULSION / SUBCUTANEOUS RLD, RS 2021-05-25 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N211488-001 CAMCEVI KIT EQ 42MG BASE EMULSION / SUBCUTANEOUS RLD, RS 2021-05-25 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N211488-001 CAMCEVI KIT EQ 42MG BASE EMULSION / SUBCUTANEOUS RLD, RS 2021-05-25 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N211488-001 CAMCEVI KIT EQ 42MG BASE EMULSION / SUBCUTANEOUS RLD, RS 2021-05-25 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N211488-001 CAMCEVI KIT EQ 42MG BASE EMULSION / SUBCUTANEOUS RLD, RS 2021-05-25 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N211488-001 CAMCEVI KIT EQ 42MG BASE EMULSION / SUBCUTANEOUS RLD, RS 2021-05-25 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N211488-001 CAMCEVI KIT EQ 42MG BASE EMULSION / SUBCUTANEOUS RLD, RS 2021-05-25 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N211488-001 CAMCEVI KIT EQ 42MG BASE EMULSION / SUBCUTANEOUS RLD, RS 2021-05-25 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N211488-001 CAMCEVI KIT EQ 42MG BASE EMULSION / SUBCUTANEOUS RLD, RS 2021-05-25 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N211488-001 CAMCEVI KIT EQ 42MG BASE EMULSION / SUBCUTANEOUS RLD, RS 2021-05-25 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 4 · 127 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N211488-001 10646572 2027-01-16 Drug product 2021-07-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211488-001 9572857 2027-01-16 Drug product 2021-07-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211488-001 9744207 2027-01-16 Drug product 2021-07-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211488-001 12133878 2037-12-18 Drug product 2024-11-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211488-001 11717555 2039-01-01 Drug product 2023-08-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211488-001 10646572 2027-01-16 Drug product 2021-07-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211488-001 9572857 2027-01-16 Drug product 2021-07-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211488-001 9744207 2027-01-16 Drug product 2021-07-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211488-001 12133878 2037-12-18 Drug product 2024-11-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211488-001 11717555 2039-01-01 Drug product 2023-08-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N211488-001 10646572 2027-01-16 Drug product 2021-07-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N211488-001 9572857 2027-01-16 Drug product 2021-07-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N211488-001 9744207 2027-01-16 Drug product 2021-07-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N211488-001 12133878 2037-12-18 Drug product 2024-11-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N211488-001 11717555 2039-01-01 Drug product 2023-08-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211488-001 10646572 2027-01-16 Drug product 2021-07-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211488-001 9572857 2027-01-16 Drug product 2021-07-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211488-001 9744207 2027-01-16 Drug product 2021-07-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211488-001 12133878 2037-12-18 Drug product 2024-11-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211488-001 11717555 2039-01-01 Drug product 2023-08-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211488-001 10646572 2027-01-16 Drug product 2021-07-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211488-001 9572857 2027-01-16 Drug product 2021-07-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211488-001 9744207 2027-01-16 Drug product 2021-07-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211488-001 12133878 2037-12-18 Drug product 2024-11-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211488-001 11717555 2039-01-01 Drug product 2023-08-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N211488-001 10646572 2027-01-16 Drug product 2021-07-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N211488-001 9572857 2027-01-16 Drug product 2021-07-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N211488-001 9744207 2027-01-16 Drug product 2021-07-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N211488-001 12133878 2037-12-18 Drug product 2024-11-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N211488-001 11717555 2039-01-01 Drug product 2023-08-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N211488-001 10646572 2027-01-16 Drug product 2021-07-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N211488-001 9572857 2027-01-16 Drug product 2021-07-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N211488-001 9744207 2027-01-16 Drug product 2021-07-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N211488-001 12133878 2037-12-18 Drug product 2024-11-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N211488-001 11717555 2039-01-01 Drug product 2023-08-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N211488-001 10646572 2027-01-16 Drug product 2021-07-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N211488-001 9572857 2027-01-16 Drug product 2021-07-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N211488-001 9744207 2027-01-16 Drug product 2021-07-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N211488-001 11717555 2039-01-01 Drug product 2023-08-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N211488-001 10646572 2027-01-16 Drug product 2021-07-15 d8e5a09893c0…
Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base CAMCEVI
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LEUPROLIDE MESYLATE 42 mg/.37g
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 69448-023-63 CAMCEVI 1 in 1 CARTON INJECTION, EMULSION 1 8 69448-023-63 CAMCEVI 0.37 g in 1 SYRINGE INJECTION, EMULSION 0.37 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69448-023 CAMCEVI (LEUPROLIDE) INJECTION, EMULSION [ACCORD BIOPHARMA, INC.] 4 Current NDC, 2 package rows 20250520_cbff25e5-6fe8-4e44-b10a-8397b3349905.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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join CAMCEVI LEUPROLIDE Accord BioPharma, Inc. d7a8761a-d953-413a-e053-2a95a90a60ee 2026-02-18 Warnings, Adverse reactions Exact identifier application applno (NDA): 211488 application number: NDA211488
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 69448-023-63 69448002363 1 SYRINGE in 1 CARTON (69448-023-63) / .37 g in 1 SYRINGE 1 syringe 2025-05-19 No No Current