Cyanokit

Product NDC
11704-370
Requested package NDC
11704-370-01
11-digit product format
117040370
Labeler code
11704
Product ID
11704-370_6e16a4c1-525d-405e-8c76-c2aa1e6909a9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxocobalamin
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Meridian Medical Technologies, Inc.
Application
NDA022041
Marketing category
NDA
Marketing start
2011-10-01
Marketing end
2024-05-24
Substance
HYDROXOCOBALAMIN
Active strength
5 g/250mL
Pharmacologic classes
Antidote [EPC]
NDC exclude flag
No
Listing certified through
0000-00-00
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage11704-37011704-370-01DDiscontinued by firm2026-08-03

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N022041-001CYANOKITHYDROXOCOBALAMIN5GM/VIAL (5GM/KIT)INJECTABLE / INJECTIONRLD, RS2011-04-08
N022041-002CYANOKITHYDROXOCOBALAMIN2.5GM/VIAL (5GM/KIT)INJECTABLE / INJECTION2006-12-15

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.

Product history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N022041-001CYANOKIT5GM/VIAL (5GM/KIT)INJECTABLE / INJECTIONRLD, RS2011-04-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022041-002CYANOKIT2.5GM/VIAL (5GM/KIT)INJECTABLE / INJECTION2006-12-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022041-001CYANOKIT5GM/VIAL (5GM/KIT)INJECTABLE / INJECTIONRLD, RS2011-04-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022041-002CYANOKIT2.5GM/VIAL (5GM/KIT)INJECTABLE / INJECTION2006-12-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08N022041-001CYANOKIT5GM/VIAL (5GM/KIT)INJECTABLE / INJECTIONRLD, RS2011-04-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022041-002CYANOKIT2.5GM/VIAL (5GM/KIT)INJECTABLE / INJECTION2006-12-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022041-001CYANOKIT5GM/VIAL (5GM/KIT)INJECTABLE / INJECTIONRLD, RS2011-04-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022041-002CYANOKIT2.5GM/VIAL (5GM/KIT)INJECTABLE / INJECTION2006-12-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022041-001CYANOKIT5GM/VIAL (5GM/KIT)INJECTABLE / INJECTIONRLD, RS2011-04-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022041-002CYANOKIT2.5GM/VIAL (5GM/KIT)INJECTABLE / INJECTION2006-12-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022041-001CYANOKIT5GM/VIAL (5GM/KIT)INJECTABLE / INJECTIONRLD, RS2011-04-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022041-002CYANOKIT2.5GM/VIAL (5GM/KIT)INJECTABLE / INJECTION2006-12-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022041-001CYANOKIT5GM/VIAL (5GM/KIT)INJECTABLE / INJECTIONRLD, RS2011-04-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022041-002CYANOKIT2.5GM/VIAL (5GM/KIT)INJECTABLE / INJECTION2006-12-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022041-001CYANOKIT5GM/VIAL (5GM/KIT)INJECTABLE / INJECTIONRLD, RS2011-04-085bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022041-002CYANOKIT2.5GM/VIAL (5GM/KIT)INJECTABLE / INJECTION2006-12-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022041-001CYANOKIT5GM/VIAL (5GM/KIT)INJECTABLE / INJECTIONRLD, RS2011-04-08d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022041-002CYANOKIT2.5GM/VIAL (5GM/KIT)INJECTABLE / INJECTION2006-12-15d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N022041-001CYANOKIT5GM/VIAL (5GM/KIT)INJECTABLE / INJECTIONRLD, RS2011-04-08d06236e962d9…
2024-10-29 15:01 UTC2024-10N022041-002CYANOKIT2.5GM/VIAL (5GM/KIT)INJECTABLE / INJECTION2006-12-15d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022041-001CYANOKIT5GM/VIAL (5GM/KIT)INJECTABLE / INJECTIONRLD, RS2011-04-0879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022041-002CYANOKIT2.5GM/VIAL (5GM/KIT)INJECTABLE / INJECTION2006-12-1579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022041-001CYANOKIT5GM/VIAL (5GM/KIT)INJECTABLE / INJECTIONRLD, RS2011-04-08301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022041-002CYANOKIT2.5GM/VIAL (5GM/KIT)INJECTABLE / INJECTION2006-12-15301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022041-001CYANOKIT5GM/VIAL (5GM/KIT)INJECTABLE / INJECTIONRLD, RS2011-04-081e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022041-002CYANOKIT2.5GM/VIAL (5GM/KIT)INJECTABLE / INJECTION2006-12-151e350fbaab3a…
2024-05-31 18:47 UTC2024-05N022041-001CYANOKIT5GM/VIAL (5GM/KIT)INJECTABLE / INJECTIONRLD, RS2011-04-088072bd15b7f6…
2024-05-31 18:47 UTC2024-05N022041-002CYANOKIT2.5GM/VIAL (5GM/KIT)INJECTABLE / INJECTION2006-12-158072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022041-001CYANOKIT5GM/VIAL (5GM/KIT)INJECTABLE / INJECTIONRLD, RS2011-04-085c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022041-002CYANOKIT2.5GM/VIAL (5GM/KIT)INJECTABLE / INJECTION2006-12-155c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N022041-001CYANOKIT5GM/VIAL (5GM/KIT)INJECTABLE / INJECTIONRLD, RS2011-04-085d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N022041-002CYANOKIT2.5GM/VIAL (5GM/KIT)INJECTABLE / INJECTION2006-12-155d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N022041-001CYANOKIT5GM/VIAL (5GM/KIT)INJECTABLE / INJECTIONRLD, RS2011-04-084b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N022041-002CYANOKIT2.5GM/VIAL (5GM/KIT)INJECTABLE / INJECTION2006-12-154b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N022041-001CYANOKIT5GM/VIAL (5GM/KIT)INJECTABLE / INJECTIONRLD, RS2011-04-0874a2ff9319b5…
2019-12-13 00:20 UTC2019-12N022041-002CYANOKIT2.5GM/VIAL (5GM/KIT)INJECTABLE / INJECTION2006-12-1574a2ff9319b5…
2022-03-09 01:35 UTC2022-03N022041-001CYANOKIT5GM/VIAL (5GM/KIT)INJECTABLE / INJECTIONRLD, RS2011-04-08bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N022041-002CYANOKIT2.5GM/VIAL (5GM/KIT)INJECTABLE / INJECTION2006-12-15bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N022041-001CYANOKIT5GM/VIAL (5GM/KIT)INJECTABLE / INJECTIONRLD, RS2011-04-08782e0a99824c…
2021-12-28 21:50 UTC2021-12N022041-002CYANOKIT2.5GM/VIAL (5GM/KIT)INJECTABLE / INJECTION2006-12-15782e0a99824c…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11704-370-01EA - Each11704-370d66d37cd-dac9-499f-bd8e-8cc863a091cc12012-07-24

DailyMed Socrata Ingredients#

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
CyanokitHYDROXOCOBALAMINBTG INTERNATIONAL INC.d56fcc8d-bd64-46ab-b0c0-2124bd745a6b2023-04-27Warnings, Adverse reactionsExact identifier
application applno (NDA): 022041
application number: NDA022041

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
11704-370-01117040370011 VIAL, GLASS in 1 CARTON (11704-370-01) > 250 mL in 1 VIAL, GLASS2011-10-012024-05-24NoNoCurrent