FDA.reportPublic FDA data

Forteo

Product NDC
0002-9678
11-digit product format
000029678
Labeler code
0002
Product ID
0002-9678_31aeb334-c6d1-4018-af85-17ef69850001
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Teriparatide
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
Eli Lilly and Company
Application
NDA021318
Marketing category
NDA
Marketing start
2025-06-03
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
Forteo
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TERIPARATIDE250 ug/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii10T9CSU89I
Rxcui1435115, 1435117

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
0002-9678-01Forteo2.24 mL in 1 SYRINGEINJECTION, SOLUTION2.2442
0002-9678-01Forteo1 in 1 CARTONINJECTION, SOLUTION142

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0002-9678-01ML - Milliliter0002-96780ac46b6b-d87b-455e-9525-d4fb98fe01e512025-09-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TeriparatideACTIVE INGREDIENT10T9CSU89IFORTEO (TERIPARATIDE) INJECTION, SOLUTION [ELI LILLY AND COMPANY]23
TeriparatideACTIVE MOIETY10T9CSU89IFORTEO (TERIPARATIDE) INJECTION, SOLUTION [ELI LILLY AND COMPANY]23
acetic acidINACTIVE INGREDIENTQ40Q9N063PFORTEO (TERIPARATIDE) INJECTION, SOLUTION [ELI LILLY AND COMPANY]23
hydrochloric acidINACTIVE INGREDIENTQTT17582CBFORTEO (TERIPARATIDE) INJECTION, SOLUTION [ELI LILLY AND COMPANY]23
mannitolINACTIVE INGREDIENT3OWL53L36AFORTEO (TERIPARATIDE) INJECTION, SOLUTION [ELI LILLY AND COMPANY]23
MetacresolINACTIVE INGREDIENTGGO4Y809LOFORTEO (TERIPARATIDE) INJECTION, SOLUTION [ELI LILLY AND COMPANY]23
sodium acetate anhydrousINACTIVE INGREDIENTNVG71ZZ7P0FORTEO (TERIPARATIDE) INJECTION, SOLUTION [ELI LILLY AND COMPANY]23
sodium hydroxideINACTIVE INGREDIENT55X04QC32IFORTEO (TERIPARATIDE) INJECTION, SOLUTION [ELI LILLY AND COMPANY]23
waterINACTIVE INGREDIENT059QF0KO0RFORTEO (TERIPARATIDE) INJECTION, SOLUTION [ELI LILLY AND COMPANY]23

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1435117FORTEO 20 MCG/Dose in 28 Dose Pen InjectorPSNaae667c5-381f-4f92-93df-2ed6158d07b042
1435115teriparatide 20 MCG/Dose in 28 Dose Pen InjectorPSNaae667c5-381f-4f92-93df-2ed6158d07b042
143511728 ACTUAT teriparatide 0.02 MG/ACTUAT Pen Injector [Forteo]SBDaae667c5-381f-4f92-93df-2ed6158d07b042
143511528 ACTUAT teriparatide 0.02 MG/ACTUAT Pen InjectorSCDaae667c5-381f-4f92-93df-2ed6158d07b042
143511728 ACTUAT Forteo 0.02 MG/ACTUAT Pen InjectorSYaae667c5-381f-4f92-93df-2ed6158d07b042
1435117Forteo 20 MCG/ACTUAT Pen Injector, 28 ACTUATSYaae667c5-381f-4f92-93df-2ed6158d07b042
1435115teriparatide 0.02 MG/ACTUAT Pen Injector, 28 ACTUATSYaae667c5-381f-4f92-93df-2ed6158d07b042
1435115teriparatide 20 MCG/ACTUAT Pen Injector, 28 ACTUATSYaae667c5-381f-4f92-93df-2ed6158d07b042

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0002-9678-01000029678011 SYRINGE in 1 CARTON (0002-9678-01) / 2.24 mL in 1 SYRINGE1 syringe2025-06-03NoNoCurrent