HyperTET

Product NDC
13533-634
11-digit product format
135330634
Labeler code
13533
Product ID
13533-634_19cd169c-5f07-44c7-a8f0-342363e5a0b5
Type
PLASMA DERIVATIVE
Nonproprietary name
Tetanus Immune Globulin (Human)
Dosage form
INJECTION
Route
INTRAMUSCULAR
Labeler
GRIFOLS USA, LLC
Application
BLA101142
Marketing category
BLA
Marketing start
1996-08-14
Substance
HUMAN CLOSTRIDIUM TETANI TOXOID IMMUNE GLOBULIN
Active strength
250 [iU]/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HUMAN CLOSTRIDIUM TETANI TOXOID IMMUNE GLOBULIN250 [iU]/mL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13533-634-02HyperTET1 in 1 BOXINJECTION120
13533-634-20HyperTET1 mL in 1 SYRINGE, GLASSINJECTION120

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13533-634-02ML - Milliliter13533-6349ce8a2ca-763a-47d8-99d1-c4e38a18993a22022-04-06
13533-634-20ML - Milliliter13533-63441bba052-8417-44f8-ab15-26e9277e240322022-04-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Human Clostridium Tetani Toxoid Immune GlobulinACTIVE INGREDIENTV4SWI4RF4JHYPERTET S/D (TETANUS IMMUNE GLOBULIN (HUMAN)) INJECTION [GRIFOLS USA, LLC]11
Human Clostridium Tetani Toxoid Immune GlobulinACTIVE MOIETYV4SWI4RF4JHYPERTET S/D (TETANUS IMMUNE GLOBULIN (HUMAN)) INJECTION [GRIFOLS USA, LLC]11
GlycineINACTIVE INGREDIENTTE7660XO1CHYPERTET S/D (TETANUS IMMUNE GLOBULIN (HUMAN)) INJECTION [GRIFOLS USA, LLC]11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13533-634HYPERTET (TETANUS IMMUNE GLOBULIN (HUMAN)) INJECTION [GRIFOLS USA, LLC]20Current NDC, Legacy NDC, 2 package rows20241006_393fa198-7e07-4162-bd0a-9d873f1544a9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1087395Hypertet 250 UNT in 1 ML Prefilled SyringePSN393fa198-7e07-4162-bd0a-9d873f1544a920
1087391tetanus immune globulin, human 250 UNT in 1 ML Prefilled SyringePSN393fa198-7e07-4162-bd0a-9d873f1544a920
10873951 ML tetanus immune globulin, human 250 UNT/ML Prefilled Syringe [Hypertet]SBD393fa198-7e07-4162-bd0a-9d873f1544a920
10873911 ML tetanus immune globulin, human 250 UNT/ML Prefilled SyringeSCD393fa198-7e07-4162-bd0a-9d873f1544a920
10873951 ML Hypertet 250 UNT/ML Prefilled SyringeSY393fa198-7e07-4162-bd0a-9d873f1544a920
1087395Hypertet S/D 250 UNT per 1 ML Prefilled SyringeSY393fa198-7e07-4162-bd0a-9d873f1544a920
1087391tetanus immune globulin, human 250 UNT per 1 ML Prefilled SyringeSY393fa198-7e07-4162-bd0a-9d873f1544a920

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
13533-634-02135330634021 SYRINGE, GLASS in 1 BOX (13533-634-02) / 1 mL in 1 SYRINGE, GLASS (13533-634-20) 1996-08-140000-00-00NoNoCurrent
13533-634-20135330634201 mL in 1 SYRINGE, GLASS1 mlHistorical