Teriparatide

Product NDC
66993-989
11-digit product format
669930989
Labeler code
66993
Product ID
66993-989_0bc59709-3046-4364-b275-14464c1e9f8f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Teriparatide
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
Prasco Laboratories
Application
NDA021318
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2025-06-16
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
66993-989-28Teriparatide2.24 mL in 1 SYRINGEINJECTION, SOLUTION2.248
66993-989-28Teriparatide1 in 1 CARTONINJECTION, SOLUTION18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66993-989-28ML - Milliliter66993-989cfa3e044-3b3a-4d06-a429-604be99ba6dc12025-11-13

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1435115teriparatide 20 MCG/Dose in 28 Dose Pen InjectorPSNab322675-4769-45b0-b146-14fbaa3135d08
143511528 ACTUAT teriparatide 0.02 MG/ACTUAT Pen InjectorSCDab322675-4769-45b0-b146-14fbaa3135d08
1435115teriparatide 0.02 MG/ACTUAT Pen Injector, 28 ACTUATSYab322675-4769-45b0-b146-14fbaa3135d08
1435115teriparatide 20 MCG/ACTUAT Pen Injector, 28 ACTUATSYab322675-4769-45b0-b146-14fbaa3135d08

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
66993-989-28669930989281 SYRINGE in 1 CARTON (66993-989-28) / 2.24 mL in 1 SYRINGE1 syringe2025-06-16NoNoCurrent