FDA.reportPublic FDA data

Cyanokit

Product NDC
50633-310
11-digit product format
506330310
Labeler code
50633
Product ID
50633-310_9955075c-c059-4b63-b387-e98ef13e60dc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxocobalamin
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
BTG INTERNATIONAL INC.
Application
NDA022041
Marketing category
NDA
Marketing start
2021-12-15
Substance
HYDROXOCOBALAMIN
Active strength
5 g/250mL
Pharmacologic classes
Antidote [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROXOCOBALAMIN5 g/250mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
Q40X8H422OInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
700496Internal RxNorm lookup
700499Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d56fcc8d-bd64-46ab-b0c0-2124bd745a6bAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50633-310-11Cyanokit1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,12
50633-310-11Cyanokit250 mL in 1 VIAL, GLASSINJECTION, POWDER, LYOPHILIZED,2502

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50633-310-11EA - Each50633-31048e28f81-756b-4ca5-b32b-11e4ae5fb15212022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50633-310CYANOKIT (HYDROXOCOBALAMIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [BTG INTERNATIONAL INC.]2Current NDC, Legacy NDC, 2 package rows20230504_d56fcc8d-bd64-46ab-b0c0-2124bd745a6b.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
CyanokitHYDROXOCOBALAMINBTG INTERNATIONAL INC.d56fcc8d-bd64-46ab-b0c0-2124bd745a6b2023-04-27Warnings, Adverse reactionsExact identifier
application applno (NDA): 022041
application number: NDA022041
ndc (product): 50633-310

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
700499CYANOKIT 5 GM InjectionPSNd56fcc8d-bd64-46ab-b0c0-2124bd745a6b2
700496hydroxocobalamin 5 GM InjectionPSNd56fcc8d-bd64-46ab-b0c0-2124bd745a6b2
700499hydroxocobalamin 5000 MG Injection [Cyanokit]SBDd56fcc8d-bd64-46ab-b0c0-2124bd745a6b2
700496hydroxocobalamin 5000 MG InjectionSCDd56fcc8d-bd64-46ab-b0c0-2124bd745a6b2
700499Cyanokit 5 GM InjectionSYd56fcc8d-bd64-46ab-b0c0-2124bd745a6b2
700499Cyanokit 5000 MG InjectionSYd56fcc8d-bd64-46ab-b0c0-2124bd745a6b2
700496hydroxocobalamin 5 GM InjectionSYd56fcc8d-bd64-46ab-b0c0-2124bd745a6b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50633-310-11506330310111 VIAL, GLASS in 1 CARTON (50633-310-11) / 250 mL in 1 VIAL, GLASS2021-12-150000-00-00NoNoCurrent