Teriparatide

Product NDC
0093-1106
11-digit product format
000931106
Labeler code
0093
Product ID
0093-1106_5e3977c0-a361-494b-ac07-0426dda5bd36
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Teriparatide
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA208569
Marketing category
ANDA
Marketing start
2023-12-18
Substance
TERIPARATIDE ACETATE
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
TERIPARATIDE ACETATE250 ug/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9959P4V12N
Rxcui1435115

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b921a6be-c897-e1d4-f6d7-f4df8c2a7a6aProduct name220250731
bc54407b-4c2b-4714-a018-cf90828b0cb1Product name120250317
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
25117fd6-247a-42b6-bd01-89f9877d0f51Product name120200304
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
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
0093-1106-16Teriparatide1 in 1 CARTONINJECTION, SOLUTION13
0093-1106-16Teriparatide2.24 mL in 1 SYRINGEINJECTION, SOLUTION2.243

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-1106-16ML - Milliliter0093-1106f8f1e34b-7c71-4d3f-ae6a-d3b50d9b019512024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0093-1106TERIPARATIDE INJECTION, SOLUTION [TEVA PHARMACEUTICALS USA, INC.]3Current NDC, 2 package rows20250313_d371f0f7-d492-4481-b360-051456d56d65.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1435115teriparatide 20 MCG/Dose in 28 Dose Pen InjectorPSNd371f0f7-d492-4481-b360-051456d56d653
143511528 ACTUAT teriparatide 0.02 MG/ACTUAT Pen InjectorSCDd371f0f7-d492-4481-b360-051456d56d653
1435115teriparatide 0.02 MG/ACTUAT Pen Injector, 28 ACTUATSYd371f0f7-d492-4481-b360-051456d56d653
1435115teriparatide 20 MCG/ACTUAT Pen Injector, 28 ACTUATSYd371f0f7-d492-4481-b360-051456d56d653

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0093-1106-16000931106161 SYRINGE in 1 CARTON (0093-1106-16) / 2.24 mL in 1 SYRINGE1 syringe2023-12-18NoNoHistorical