ZOSTAVAX

Product NDC
0006-4963
11-digit product format
000064963
Labeler code
0006
Product ID
0006-4963_4608a61b-13c5-44f0-b3fd-eab84bf16b92
Type
VACCINE
Nonproprietary name
Zoster Vaccine Live
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION
Route
SUBCUTANEOUS
Labeler
Merck Sharp & Dohme LLC
Application
BLA125123
Marketing category
BLA
Marketing start
2006-05-25
Marketing end
0000-00-00
Substance
VARICELLA-ZOSTER VIRUS STRAIN OKA/MERCK LIVE ANTIGEN
Active strength
19400 [PFU]/.65mL
Pharmacologic classes
Actively Acquired Immunity [PE], Chickenpox Vaccine [CS], Herpes Zoster Vaccine [CS], Live Attenuated Herpes Zoster Virus Vaccine [EPC], Live Attenuated Varicella Zoster Virus Vaccine [EPC], Vaccines, Attenuated [CS]
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0006-4963DDiscontinued by firm2026-08-17
excluded packagepackage0006-49630006-4963-00DDiscontinued by firm2026-08-17
excluded packagepackage0006-49630006-4963-41DDiscontinued by firm2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 36 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0006-4963-41d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0006-4963-00d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0006-4963-41f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0006-4963-00f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0006-4963-412ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0006-4963-002ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0006-4963-41a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0006-4963-00a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0006-4963-41cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0006-4963-00cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0006-4963-41cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0006-4963-00cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0006-4963-41302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0006-4963-00302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0006-4963-41ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0006-4963-00ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0006-4963-410efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0006-4963-000efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0006-4963-41ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0006-4963-00ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0006-4963-41367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0006-4963-00367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0006-4963-41557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0006-4963-00557ba5c1ecfa…9c80585c8c6e…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0006-4963-00EA - Each0006-4963bf5b0d46-04d4-4739-912e-faa6caaf98de12013-02-13
0006-4963-01EA - Each0006-49639a5c5147-ae7e-46c2-be30-ec13104f070a12015-05-05
0006-4963-41EA - Each0006-496387035ba3-cc2b-4da0-9222-8aa87242af3612013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
VARICELLA-ZOSTER VIRUS STRAIN OKA/MERCK LIVE ANTIGENACTIVE INGREDIENTGPV39ZGD8CZOSTAVAX (ZOSTER VACCINE LIVE) INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION STERILE DILUENT (STERILE WATER) INJECTION [MERCK SHARP & DOHME CORP.]28
VARICELLA-ZOSTER VIRUS STRAIN OKA/MERCK LIVE ANTIGENACTIVE MOIETYGPV39ZGD8CZOSTAVAX (ZOSTER VACCINE LIVE) INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION STERILE DILUENT (STERILE WATER) INJECTION [MERCK SHARP & DOHME CORP.]28
ALBUMIN BOVINEINACTIVE INGREDIENT27432CM55QZOSTAVAX (ZOSTER VACCINE LIVE) INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION STERILE DILUENT (STERILE WATER) INJECTION [MERCK SHARP & DOHME CORP.]28
GELATININACTIVE INGREDIENT2G86QN327LZOSTAVAX (ZOSTER VACCINE LIVE) INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION STERILE DILUENT (STERILE WATER) INJECTION [MERCK SHARP & DOHME CORP.]28
MONOSODIUM GLUTAMATEINACTIVE INGREDIENTW81N5U6R6UZOSTAVAX (ZOSTER VACCINE LIVE) INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION STERILE DILUENT (STERILE WATER) INJECTION [MERCK SHARP & DOHME CORP.]28
NEOMYCININACTIVE INGREDIENTI16QD7X297ZOSTAVAX (ZOSTER VACCINE LIVE) INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION STERILE DILUENT (STERILE WATER) INJECTION [MERCK SHARP & DOHME CORP.]28
POTASSIUM CHLORIDEINACTIVE INGREDIENT660YQ98I10ZOSTAVAX (ZOSTER VACCINE LIVE) INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION STERILE DILUENT (STERILE WATER) INJECTION [MERCK SHARP & DOHME CORP.]28
POTASSIUM PHOSPHATE, MONOBASICINACTIVE INGREDIENT4J9FJ0HL51ZOSTAVAX (ZOSTER VACCINE LIVE) INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION STERILE DILUENT (STERILE WATER) INJECTION [MERCK SHARP & DOHME CORP.]28
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XZOSTAVAX (ZOSTER VACCINE LIVE) INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION STERILE DILUENT (STERILE WATER) INJECTION [MERCK SHARP & DOHME CORP.]28
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA74ZOSTAVAX (ZOSTER VACCINE LIVE) INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION STERILE DILUENT (STERILE WATER) INJECTION [MERCK SHARP & DOHME CORP.]28
SUCROSEINACTIVE INGREDIENTC151H8M554ZOSTAVAX (ZOSTER VACCINE LIVE) INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION STERILE DILUENT (STERILE WATER) INJECTION [MERCK SHARP & DOHME CORP.]28

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125123ZostavaxZoster Vaccine Live351(a)Disc2026-07-01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0006-4963-00000064963001 VIAL, SINGLE-DOSE in 1 CARTON (0006-4963-00) > .65 mL in 1 VIAL, SINGLE-DOSE (0006-4963-01) 2006-05-250000-00-00NoNoCurrent
0006-4963-410000649634110 VIAL, SINGLE-DOSE in 1 CARTON (0006-4963-41) > .65 mL in 1 VIAL, SINGLE-DOSE (0006-4963-01) 2006-05-250000-00-00NoNoCurrent