Teriparatide

Product NDC
60505-6188
11-digit product format
605056188
Labeler code
60505
Product ID
60505-6188_8f15c891-ec65-6632-c161-e7bddfc3b3f2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Teriparatide
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
Apotex Corp.
Application
ANDA211097
Marketing category
ANDA
Marketing start
2023-11-16
Substance
TERIPARATIDE
Active strength
250 ug/mL
Pharmacologic classes
Parathyroid Hormone Analog [EPC], Parathyroid Hormone [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Teriparatide
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TERIPARATIDE250 ug/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii10T9CSU89I
Rxcui1435115

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b921a6be-c897-e1d4-f6d7-f4df8c2a7a6aProduct name220250731
bc54407b-4c2b-4714-a018-cf90828b0cb1Product name120250317
a21a21e5-f36d-4c1f-8918-def921b8f7e3Product name320250124
25117fd6-247a-42b6-bd01-89f9877d0f51Product name120200304
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60505-6188-0Teriparatide1 in 1 CARTONINJECTION, SOLUTION18
60505-6188-0Teriparatide2.4 mL in 1 SYRINGEINJECTION, SOLUTION2.48

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-6188-0ML - Milliliter60505-6188d15bc6b7-862c-4ad6-8c10-6f73acc1668b12023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-6188TERIPARATIDE INJECTION, SOLUTION [APOTEX CORP.]7Current NDC, 2 package rows20250511_d77d40db-7f38-88eb-fd5d-4282f0642028.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1435115teriparatide 20 MCG/Dose in 28 Dose Pen InjectorPSNd77d40db-7f38-88eb-fd5d-4282f06420288
143511528 ACTUAT teriparatide 0.02 MG/ACTUAT Pen InjectorSCDd77d40db-7f38-88eb-fd5d-4282f06420288
1435115teriparatide 0.02 MG/ACTUAT Pen Injector, 28 ACTUATSYd77d40db-7f38-88eb-fd5d-4282f06420288
1435115teriparatide 20 MCG/ACTUAT Pen Injector, 28 ACTUATSYd77d40db-7f38-88eb-fd5d-4282f06420288

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
60505-6188-0605056188001 SYRINGE in 1 CARTON (60505-6188-0) / 2.4 mL in 1 SYRINGE1 syringe2023-11-17NoNoCurrent