FDA.reportPublic FDA data

Teriparatide

Product NDC
0548-2311
11-digit product format
005482311
Labeler code
0548
Product ID
0548-2311_0fe663ce-2f30-4de1-b873-804b21779241
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Teriparatide
Dosage form
INJECTION
Route
SUBCUTANEOUS
Labeler
Amphastar Pharmaceuticals, Inc.
Application
ANDA213641
Marketing category
ANDA
Marketing start
2025-12-22
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A213641-001TERIPARATIDETERIPARATIDE0.56MG/2.24ML (0.25MG/ML)SOLUTION / SUBCUTANEOUSAP2025-12-12

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A213641-001AP

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A213641-001TERIPARATIDE0.56MG/2.24ML (0.25MG/ML)SOLUTION / SUBCUTANEOUSAP2025-12-12011fe1cb6892…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A213641-001TERIPARATIDE0.56MG/2.24ML (0.25MG/ML)SOLUTION / SUBCUTANEOUSAP2025-12-12a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A213641-001AP1011fe1cb6892…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A213641-001AP1a50c72e98297…

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
10T9CSU89IInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1435115Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
d38b470a-2e62-487b-b3e7-134d3d1958b5Available on FDA.report

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
0548-2311-00Teriparatide2.24 mL in 1 SYRINGEINJECTION2.242
0548-2311-00Teriparatide1 in 1 CARTONINJECTION12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0548-2311-00ML - Milliliter0548-23119a0c11c2-84ef-4604-8cb4-a81913986a9012026-01-08

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TeriparatideTERIPARATIDEBluePoint Laboratories9d3f65e2-e8f0-4d33-b79e-989013dd3ca32026-03-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213641
application number: ANDA213641
TeriparatideTERIPARATIDEAmphastar Pharmaceuticals, Inc.d38b470a-2e62-487b-b3e7-134d3d1958b52025-12-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213641
application number: ANDA213641
ndc (product): 0548-2311

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1435115teriparatide 20 MCG/Dose in 28 Dose Pen InjectorPSNd38b470a-2e62-487b-b3e7-134d3d1958b52
143511528 ACTUAT teriparatide 0.02 MG/ACTUAT Pen InjectorSCDd38b470a-2e62-487b-b3e7-134d3d1958b52
1435115teriparatide 0.02 MG/ACTUAT Pen Injector, 28 ACTUATSYd38b470a-2e62-487b-b3e7-134d3d1958b52
1435115teriparatide 20 MCG/ACTUAT Pen Injector, 28 ACTUATSYd38b470a-2e62-487b-b3e7-134d3d1958b52

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0548-2311-00005482311001 SYRINGE in 1 CARTON (0548-2311-00) / 2.24 mL in 1 SYRINGE1 syringe2025-12-22NoNoCurrent