Exenatide

Product NDC
70121-1686
11-digit product format
701211686
Labeler code
70121
Product ID
70121-1686_b5cc060b-1669-4bee-b0f7-911b5d188547
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Exenatide
Dosage form
INJECTION
Route
SUBCUTANEOUS
Labeler
Amneal Pharmaceuticals LLC
Application
ANDA206697
Marketing category
ANDA
Marketing start
2024-11-22
Substance
EXENATIDE
Active strength
250 ug/mL
Pharmacologic classes
GLP-1 Receptor Agonist [EPC], Glucagon-Like Peptide 1 [CS], Glucagon-like Peptide-1 (GLP-1) 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
Exenatide
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
EXENATIDE250 ug/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9P1872D4OL
Rxcui847910, 847915

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
910a43af-bf3b-4a75-af76-a237c61fbc82Product name120250717
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
8f64a1da-980a-4c97-8c3f-c572643b48f9Product name120171212
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70121-1686-1Exenatide1 in 1 CARTONINJECTION116
70121-1686-1Exenatide2.4 mL in 1 CARTRIDGEINJECTION2.416

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70121-1686-1ML - Milliliter70121-1686f201792c-fa7b-47cb-bcdb-7226cf513b4112025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70121-1686EXENATIDE INJECTION [AMNEAL PHARMACEUTICALS LLC]11Current NDC, 2 package rows20241123_e6cb5c8f-e97f-4a6a-95a4-939fd2393949.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
847910exenatide 10 MCG, 250 MCG/ML in 2.4 mL Pen InjectorPSNe6cb5c8f-e97f-4a6a-95a4-939fd239394916
847915exenatide 5 MCG, 250 MCG/ML in 1.2 mL Pen InjectorPSNe6cb5c8f-e97f-4a6a-95a4-939fd239394916
84791560 ACTUAT exenatide 0.005 MG/ACTUAT Pen InjectorSCDe6cb5c8f-e97f-4a6a-95a4-939fd239394916
84791060 ACTUAT exenatide 0.01 MG/ACTUAT Pen InjectorSCDe6cb5c8f-e97f-4a6a-95a4-939fd239394916
847910exenatide 10 MCG/ACTUAT Pen Injector, 60 ACTUATSYe6cb5c8f-e97f-4a6a-95a4-939fd239394916
847915exenatide 250 MCG/ML Pen Injector, 1.2 MLSYe6cb5c8f-e97f-4a6a-95a4-939fd239394916
847910exenatide 250 MCG/ML Pen Injector, 2.4 MLSYe6cb5c8f-e97f-4a6a-95a4-939fd239394916
847915exenatide 5 MCG/ACTUAT Pen Injector, 60 ACTUATSYe6cb5c8f-e97f-4a6a-95a4-939fd239394916

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70121-1686-1701211686011 CARTRIDGE in 1 CARTON (70121-1686-1) / 2.4 mL in 1 CARTRIDGE1 cartridge2024-11-22NoNoCurrent