FDA.reportPublic FDA data

NATPARA (parathyroid hormone)

Product NDC
68875-0202
11-digit product format
688750202
Labeler code
68875
Product ID
68875-0202_4e21ad11-e629-4a31-97ab-3c6f03703c47
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PARATHYROID HORMONE
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
SUBCUTANEOUS
Labeler
Takeda Pharmaceuticals America, Inc.
Application
BLA125511
Marketing category
BLA
Marketing start
2015-01-23
Marketing end
0000-00-00
Substance
PARATHYROID HORMONE
Active strength
25 ug/.08mL
Pharmacologic classes
Parathyroid Hormone [CS], Parathyroid Hormone [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68875-0202DDiscontinued by firm2026-08-11
excluded packagepackage68875-020268875-0202-2DDiscontinued by firm2026-08-11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68875-0202-1EA - Each68875-0202d35bd71d-5717-4b4c-9464-698aa76f299312015-10-02
68875-0202-2EA - Each68875-02026bc8cb44-4e4a-431b-9717-06c63b17d5a812015-05-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
parathyroid hormoneACTIVE INGREDIENTN19A0T0E5JNATPARA (PARATHYROID HORMONE) (PARATHYROID HORMONE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [NPS PHARMACEUTICALS, INC.]2
parathyroid hormoneACTIVE MOIETYN19A0T0E5JNATPARA (PARATHYROID HORMONE) (PARATHYROID HORMONE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [NPS PHARMACEUTICALS, INC.]2
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPNATPARA (PARATHYROID HORMONE) (PARATHYROID HORMONE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [NPS PHARMACEUTICALS, INC.]2
MANNITOLINACTIVE INGREDIENT3OWL53L36ANATPARA (PARATHYROID HORMONE) (PARATHYROID HORMONE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [NPS PHARMACEUTICALS, INC.]2
METACRESOLINACTIVE INGREDIENTGGO4Y809LONATPARA (PARATHYROID HORMONE) (PARATHYROID HORMONE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [NPS PHARMACEUTICALS, INC.]2
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XNATPARA (PARATHYROID HORMONE) (PARATHYROID HORMONE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [NPS PHARMACEUTICALS, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RNATPARA (PARATHYROID HORMONE) (PARATHYROID HORMONE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [NPS PHARMACEUTICALS, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68875-0202NATPARA (PARATHYROID HORMONE) (PARATHYROID HORMONE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [TAKEDA PHARMACEUTICALS AMERICA, INC.]16Legacy NDC20230524_d11fba31-0a6c-11e3-8ffd-0800200c9a66.zip

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125511Natparaparathyroid hormone351(a)Rx2026-06-01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68875-0202-2688750202022 CARTRIDGE in 1 CARTON (68875-0202-2) > 1.13 mL in 1 CARTRIDGE (68875-0202-1) 2 cartridge2015-01-230000-00-00NoNoCurrent