FDA.reportPublic FDA data

CAMCEVI

Product NDC
69448-014
11-digit product format
694480014
Labeler code
69448
Product ID
69448-014_4b1ada65-9911-eacf-e063-6394a90af9d9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LEUPROLIDE
Dosage form
INJECTION, EMULSION
Route
SUBCUTANEOUS
Labeler
Accord BioPharma, Inc.
Application
NDA211488
Marketing category
NDA
Marketing start
2022-04-05
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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEUPROLIDE MESYLATE42 mg/.37g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8E3C3C493W
Rxcui2595044, 2595049

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9e666f57-491f-16e0-fc75-cc1c9f2fe06fProduct name420250515
43944b95-6cc2-4eca-846a-a5e0ed070616Product name120240501
f3ff4518-37fe-47a0-8a1e-6ce032a3efd5Product name120230829
2ed2d111-4d16-4e2a-9b09-7d196056f6c9Product name120211214
ce98e98f-fa6b-48a6-8ad2-9ef8e8098f26Product name120200925
23ede539-308f-46e5-817b-41ef23af8d40Product name120150930
425e3610-bbe8-4d70-9c46-8cf09afc4e4dProduct name120150930
ae18ed71-8057-40ec-987f-83624e50b906Product name120150122

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69448-014-63CAMCEVI1 in 1 CARTONINJECTION, EMULSION19
69448-014-63CAMCEVI0.37 g in 1 SYRINGEINJECTION, EMULSION0.379

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69448-014-63EA - Each69448-014c78b575d-61db-4b17-9d79-67673145bbe112022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69448-014CAMCEVI (LEUPROLIDE) INJECTION, EMULSION [ACCORD BIOPHARMA, INC.]6Current NDC, Legacy NDC, 2 package rows20250227_d7a8761a-d953-413a-e053-2a95a90a60ee.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2595049CAMCEVI 42 MG Prefilled SyringePSNd7a8761a-d953-413a-e053-2a95a90a60ee9
2595044leuprolide 42 MG Prefilled SyringePSNd7a8761a-d953-413a-e053-2a95a90a60ee9
2595049leuprolide 42 MG Prefilled Syringe [Camcevi]SBDd7a8761a-d953-413a-e053-2a95a90a60ee9
2595044leuprolide 42 MG Prefilled SyringeSCDd7a8761a-d953-413a-e053-2a95a90a60ee9
2595049Camcevi 42 MG Prefilled SyringeSYd7a8761a-d953-413a-e053-2a95a90a60ee9
2595044leuprolide 42 MG (as leuprolide mesylate 48 MG) Prefilled SyringeSYd7a8761a-d953-413a-e053-2a95a90a60ee9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69448-014-63694480014631 SYRINGE in 1 CARTON (69448-014-63) / .37 g in 1 SYRINGE1 syringe2022-04-050000-00-00NoNoCurrent