Teriparatide

Product NDC
68001-693
11-digit product format
680010693
Labeler code
68001
Product ID
68001-693_4cd2aa1d-db1c-1e34-e063-6294a90a48c9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Teriparatide
Dosage form
INJECTION
Route
SUBCUTANEOUS
Labeler
BluePoint Laboratories
Application
ANDA213641
Marketing category
ANDA
Marketing start
2026-03-19
Substance
TERIPARATIDE
Active strength
250 ug/mL
Pharmacologic classes
Parathyroid Hormone Analog [EPC], Parathyroid Hormone [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

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
68001-693-76Teriparatide2.24 mL in 1 SYRINGEINJECTION2.241
68001-693-76Teriparatide1 in 1 CARTONINJECTION11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68001-693-76ML - Milliliter68001-693a1d30c05-1637-416e-9226-0f033cd28b9712026-03-17

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1435115teriparatide 20 MCG/Dose in 28 Dose Pen InjectorPSN9d3f65e2-e8f0-4d33-b79e-989013dd3ca31
143511528 ACTUAT teriparatide 0.02 MG/ACTUAT Pen InjectorSCD9d3f65e2-e8f0-4d33-b79e-989013dd3ca31
1435115teriparatide 0.02 MG/ACTUAT Pen Injector, 28 ACTUATSY9d3f65e2-e8f0-4d33-b79e-989013dd3ca31
1435115teriparatide 20 MCG/ACTUAT Pen Injector, 28 ACTUATSY9d3f65e2-e8f0-4d33-b79e-989013dd3ca31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68001-693-76680010693761 SYRINGE in 1 CARTON (68001-693-76) / 2.24 mL in 1 SYRINGE1 syringe2026-03-19NoNoHistorical