Home NDC 51285-138 Adenovirus Type 4 and Type 7 Vaccine, Live
Product NDC 51285-138
11-digit product format 512850138
Labeler code 51285
Product ID 51285-138_07bf8d78-4199-484b-8298-060f84fc1b02
Type VACCINE
Nonproprietary name Adenovirus Type 4 and Type 7 Vaccine, Live
Dosage form KIT
Labeler Teva Women's Health, Inc.
Application BLA125296
Marketing category BLA
Marketing start 2011-09-16
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base Adenovirus Type 4 and Type 7 Vaccine, Live
Listing expiration 2026-12-31 DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 51285-138-50 Adenovirus Type 4 and Type 7 Vaccine, Live 1 in 1 CARTON KIT 1 14 51285-174-02 Adenovirus Type 4 and Type 7 Vaccine, Live 100 in 1 BOTTLE TABLET, COATED 100 32000 [TCID_50] 14 51285-175-02 Adenovirus Type 4 and Type 7 Vaccine, Live 100 in 1 BOTTLE TABLET, COATED 100 32000 [TCID_50] 14
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded HUMAN ADENOVIRUS B SEROTYPE 7 STRAIN 55142 ACTIVE INGREDIENT TM54L796SN ADENOVIRUS TYPE 4 AND TYPE 7 VACCINE, LIVE KIT [TEVA WOMEN'S HEALTH, INC.] 4 HUMAN ADENOVIRUS E SEROTYPE 4 STRAIN CL-68578 ACTIVE INGREDIENT FKD3DUK39I ADENOVIRUS TYPE 4 AND TYPE 7 VACCINE, LIVE KIT [TEVA WOMEN'S HEALTH, INC.] 4 HUMAN ADENOVIRUS B SEROTYPE 7 STRAIN 55142 ACTIVE MOIETY TM54L796SN ADENOVIRUS TYPE 4 AND TYPE 7 VACCINE, LIVE KIT [TEVA WOMEN'S HEALTH, INC.] 4 HUMAN ADENOVIRUS E SEROTYPE 4 STRAIN CL-68578 ACTIVE MOIETY FKD3DUK39I ADENOVIRUS TYPE 4 AND TYPE 7 VACCINE, LIVE KIT [TEVA WOMEN'S HEALTH, INC.] 4 ALBUMIN HUMAN INACTIVE INGREDIENT ZIF514RVZR ADENOVIRUS TYPE 4 AND TYPE 7 VACCINE, LIVE KIT [TEVA WOMEN'S HEALTH, INC.] 4 ALUMINUM OXIDE INACTIVE INGREDIENT LMI26O6933 ADENOVIRUS TYPE 4 AND TYPE 7 VACCINE, LIVE KIT [TEVA WOMEN'S HEALTH, INC.] 4 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK ADENOVIRUS TYPE 4 AND TYPE 7 VACCINE, LIVE KIT [TEVA WOMEN'S HEALTH, INC.] 4 CASTOR OIL INACTIVE INGREDIENT D5340Y2I9G ADENOVIRUS TYPE 4 AND TYPE 7 VACCINE, LIVE KIT [TEVA WOMEN'S HEALTH, INC.] 4 CELLACEFATE INACTIVE INGREDIENT F2O5O2OI9F ADENOVIRUS TYPE 4 AND TYPE 7 VACCINE, LIVE KIT [TEVA WOMEN'S HEALTH, INC.] 4 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ADENOVIRUS TYPE 4 AND TYPE 7 VACCINE, LIVE KIT [TEVA WOMEN'S HEALTH, INC.] 4 DEXTROSE INACTIVE INGREDIENT IY9XDZ35W2 ADENOVIRUS TYPE 4 AND TYPE 7 VACCINE, LIVE KIT [TEVA WOMEN'S HEALTH, INC.] 4 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 ADENOVIRUS TYPE 4 AND TYPE 7 VACCINE, LIVE KIT [TEVA WOMEN'S HEALTH, INC.] 4 FRUCTOSE INACTIVE INGREDIENT 6YSS42VSEV ADENOVIRUS TYPE 4 AND TYPE 7 VACCINE, LIVE KIT [TEVA WOMEN'S HEALTH, INC.] 4 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ADENOVIRUS TYPE 4 AND TYPE 7 VACCINE, LIVE KIT [TEVA WOMEN'S HEALTH, INC.] 4 MANNOSE, D- INACTIVE INGREDIENT PHA4727WTP ADENOVIRUS TYPE 4 AND TYPE 7 VACCINE, LIVE KIT [TEVA WOMEN'S HEALTH, INC.] 4 MONOSODIUM GLUTAMATE INACTIVE INGREDIENT W81N5U6R6U ADENOVIRUS TYPE 4 AND TYPE 7 VACCINE, LIVE KIT [TEVA WOMEN'S HEALTH, INC.] 4 POLACRILIN POTASSIUM INACTIVE INGREDIENT 0BZ5A00FQU ADENOVIRUS TYPE 4 AND TYPE 7 VACCINE, LIVE KIT [TEVA WOMEN'S HEALTH, INC.] 4 POTASSIUM PHOSPHATE, UNSPECIFIED FORM INACTIVE INGREDIENT B7862WZ632 ADENOVIRUS TYPE 4 AND TYPE 7 VACCINE, LIVE KIT [TEVA WOMEN'S HEALTH, INC.] 4 SUCROSE INACTIVE INGREDIENT C151H8M554 ADENOVIRUS TYPE 4 AND TYPE 7 VACCINE, LIVE KIT [TEVA WOMEN'S HEALTH, INC.] 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51285-138 ADENOVIRUS TYPE 4 AND TYPE 7 VACCINE, LIVE KIT [TEVA WOMEN'S HEALTH, INC.] 14 Current NDC, Legacy NDC, 3 package rows 20220727_c7d0b43c-7250-4809-8a05-fcde5862f076.zip
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 125296 Adenovirus Type 4 and Type 7 Vaccine, Live, Oral 351(a) Rx 2026-06-01
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 51285-138-50 51285013850 1 KIT in 1 CARTON (51285-138-50) * 100 TABLET, COATED in 1 BOTTLE (51285-175-02) * 100 TABLET, COATED in 1 BOTTLE (51285-174-02) 1 kit 2011-09-16 0000-00-00 No No Current 51285-174-02 51285017402 100 in 1 BOTTLE Historical 51285-175-02 51285017502 100 in 1 BOTTLE Historical