FDA.reportPublic FDA data

AMPHADASE

Product NDC
0548-9090
11-digit product format
005489090
Labeler code
0548
Product ID
0548-9090_188cabde-5b1f-4083-8b6c-5dcb85f728d2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
hyaluronidase
Dosage form
INJECTION
Route
SUBCUTANEOUS
Labeler
Amphastar Pharmaceuticals, Inc.
Application
BLA021665
Marketing category
BLA
Marketing start
2004-10-26
Substance
HYALURONIDASE
Active strength
150 [USP'U]/mL
Pharmacologic classes
Endoglycosidase [EPC], Glycoside Hydrolases [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
AMPHADASE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYALURONIDASE150 [USP'U]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8KOG53Z5EMInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
238271Internal RxNorm lookup
542925Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
8396ea96-7cb5-4e26-87a4-90bca9c3c6ddAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
980b5d64-e8e5-e1c9-b721-75e08f4e00a1Product name220200323
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0548-9090-10AMPHADASE10 in 1 CARTONINJECTION1011
0548-9090-10AMPHADASE1 mL in 1 VIAL, SINGLE-DOSEINJECTION111

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0548-9090-00ML - Milliliter0548-90907365db0a-16cc-42d5-8c4c-b2297534013512012-07-24
0548-9090-10ML - Milliliter0548-9090dcaffc48-4438-41bb-b59e-da369a71241b12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
hyaluronidaseACTIVE INGREDIENT8KOG53Z5EMAMPHADASE (HYALURONIDASE ) INJECTION [AMPHASTAR PHARMACEUTICALS, INC. ]6
hyaluronidaseACTIVE MOIETY8KOG53Z5EMAMPHADASE (HYALURONIDASE ) INJECTION [AMPHASTAR PHARMACEUTICALS, INC. ]6
calcium chlorideINACTIVE INGREDIENTM4I0D6VV5MAMPHADASE (HYALURONIDASE ) INJECTION [AMPHASTAR PHARMACEUTICALS, INC. ]6
edetate disodiumINACTIVE INGREDIENT7FLD91C86KAMPHADASE (HYALURONIDASE ) INJECTION [AMPHASTAR PHARMACEUTICALS, INC. ]6
sodium chlorideINACTIVE INGREDIENT451W47IQ8XAMPHADASE (HYALURONIDASE ) INJECTION [AMPHASTAR PHARMACEUTICALS, INC. ]6
SODIUM PHOSPHATE, MONOBASICINACTIVE INGREDIENT3980JIH2SWAMPHADASE (HYALURONIDASE ) INJECTION [AMPHASTAR PHARMACEUTICALS, INC. ]6
thimerosalINACTIVE INGREDIENT2225PI3MOVAMPHADASE (HYALURONIDASE ) INJECTION [AMPHASTAR PHARMACEUTICALS, INC. ]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0548-9090AMPHADASE (HYALURONIDASE ) INJECTION [AMPHASTAR PHARMACEUTICALS, INC. ]11Current NDC, Legacy NDC, 2 package rows20240910_8396ea96-7cb5-4e26-87a4-90bca9c3c6dd.zip

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AMPHADASEHYALURONIDASEAmphastar Pharmaceuticals, Inc.8396ea96-7cb5-4e26-87a4-90bca9c3c6dd2024-02-01Warnings, Adverse reactionsExact identifier
application number: BLA021665
ndc (product): 0548-9090

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
021665Amphadasehyaluronidase351(a)Rx2026-07-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
542925AMPHADASE 150 UNT in 1 ML InjectionPSN8396ea96-7cb5-4e26-87a4-90bca9c3c6dd11
238271hyaluronidase, bovine 150 UNT in 1 ML InjectionPSN8396ea96-7cb5-4e26-87a4-90bca9c3c6dd11
5429251 ML hyaluronidase, bovine 150 UNT/ML Injection [Amphadase]SBD8396ea96-7cb5-4e26-87a4-90bca9c3c6dd11
2382711 ML hyaluronidase, bovine 150 UNT/ML InjectionSCD8396ea96-7cb5-4e26-87a4-90bca9c3c6dd11
542925Amphadase 150 UNT per 1 ML InjectionSY8396ea96-7cb5-4e26-87a4-90bca9c3c6dd11
238271hyaluronidase, bovine 150 UNT per 1 ML InjectionSY8396ea96-7cb5-4e26-87a4-90bca9c3c6dd11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0548-9090-100054890901010 VIAL, SINGLE-DOSE in 1 CARTON (0548-9090-10) / 1 mL in 1 VIAL, SINGLE-DOSE2004-10-260000-00-00NoNoCurrent