teriparatide

Product NDC
47781-652
11-digit product format
477810652
Labeler code
47781
Product ID
47781-652_78a0b591-7cbc-7cd1-1b40-b83f3699c2cf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
teriparatide
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
Alvogen, Inc.
Application
NDA211939
Marketing category
NDA
Marketing start
2019-11-14
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
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
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
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
47781-652-89teriparatide2.24 mL in 1 SYRINGEINJECTION, SOLUTION2.248
47781-652-89teriparatide1 in 1 CARTONINJECTION, SOLUTION18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
47781-652-89ML - Milliliter47781-65247233b73-7690-45dd-9f4c-2a1ebefbb1ff12020-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47781-652TERIPARATIDE INJECTION, SOLUTION [ALVOGEN, INC.]7Current NDC, Legacy NDC, 2 package rows20241101_1b007339-dd0d-f019-5e0a-9b1b0f75011c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1435115teriparatide 20 MCG/Dose in 28 Dose Pen InjectorPSN1b007339-dd0d-f019-5e0a-9b1b0f75011c8
143511528 ACTUAT teriparatide 0.02 MG/ACTUAT Pen InjectorSCD1b007339-dd0d-f019-5e0a-9b1b0f75011c8
1435115teriparatide 0.02 MG/ACTUAT Pen Injector, 28 ACTUATSY1b007339-dd0d-f019-5e0a-9b1b0f75011c8
1435115teriparatide 20 MCG/ACTUAT Pen Injector, 28 ACTUATSY1b007339-dd0d-f019-5e0a-9b1b0f75011c8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
47781-652-89477810652891 SYRINGE in 1 CARTON (47781-652-89) / 2.24 mL in 1 SYRINGE1 syringe2019-11-140000-00-00NoNoCurrent