Home NDC 11704-370-01 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 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 date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N022041-001 CYANOKIT HYDROXOCOBALAMIN 5GM/VIAL (5GM/KIT) INJECTABLE / INJECTION RLD, RS 2011-04-08 N022041-002 CYANOKIT HYDROXOCOBALAMIN 2.5GM/VIAL (5GM/KIT) INJECTABLE / INJECTION 2006-12-15
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N022041-001 CYANOKIT 5GM/VIAL (5GM/KIT) INJECTABLE / INJECTION RLD, RS 2011-04-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022041-002 CYANOKIT 2.5GM/VIAL (5GM/KIT) INJECTABLE / INJECTION 2006-12-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022041-001 CYANOKIT 5GM/VIAL (5GM/KIT) INJECTABLE / INJECTION RLD, RS 2011-04-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022041-002 CYANOKIT 2.5GM/VIAL (5GM/KIT) INJECTABLE / INJECTION 2006-12-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022041-001 CYANOKIT 5GM/VIAL (5GM/KIT) INJECTABLE / INJECTION RLD, RS 2011-04-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022041-002 CYANOKIT 2.5GM/VIAL (5GM/KIT) INJECTABLE / INJECTION 2006-12-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022041-001 CYANOKIT 5GM/VIAL (5GM/KIT) INJECTABLE / INJECTION RLD, RS 2011-04-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022041-002 CYANOKIT 2.5GM/VIAL (5GM/KIT) INJECTABLE / INJECTION 2006-12-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022041-001 CYANOKIT 5GM/VIAL (5GM/KIT) INJECTABLE / INJECTION RLD, RS 2011-04-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022041-002 CYANOKIT 2.5GM/VIAL (5GM/KIT) INJECTABLE / INJECTION 2006-12-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022041-001 CYANOKIT 5GM/VIAL (5GM/KIT) INJECTABLE / INJECTION RLD, RS 2011-04-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022041-002 CYANOKIT 2.5GM/VIAL (5GM/KIT) INJECTABLE / INJECTION 2006-12-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022041-001 CYANOKIT 5GM/VIAL (5GM/KIT) INJECTABLE / INJECTION RLD, RS 2011-04-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022041-002 CYANOKIT 2.5GM/VIAL (5GM/KIT) INJECTABLE / INJECTION 2006-12-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022041-001 CYANOKIT 5GM/VIAL (5GM/KIT) INJECTABLE / INJECTION RLD, RS 2011-04-08 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022041-002 CYANOKIT 2.5GM/VIAL (5GM/KIT) INJECTABLE / INJECTION 2006-12-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022041-001 CYANOKIT 5GM/VIAL (5GM/KIT) INJECTABLE / INJECTION RLD, RS 2011-04-08 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022041-002 CYANOKIT 2.5GM/VIAL (5GM/KIT) INJECTABLE / INJECTION 2006-12-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022041-001 CYANOKIT 5GM/VIAL (5GM/KIT) INJECTABLE / INJECTION RLD, RS 2011-04-08 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N022041-002 CYANOKIT 2.5GM/VIAL (5GM/KIT) INJECTABLE / INJECTION 2006-12-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022041-001 CYANOKIT 5GM/VIAL (5GM/KIT) INJECTABLE / INJECTION RLD, RS 2011-04-08 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022041-002 CYANOKIT 2.5GM/VIAL (5GM/KIT) INJECTABLE / INJECTION 2006-12-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022041-001 CYANOKIT 5GM/VIAL (5GM/KIT) INJECTABLE / INJECTION RLD, RS 2011-04-08 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022041-002 CYANOKIT 2.5GM/VIAL (5GM/KIT) INJECTABLE / INJECTION 2006-12-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022041-001 CYANOKIT 5GM/VIAL (5GM/KIT) INJECTABLE / INJECTION RLD, RS 2011-04-08 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022041-002 CYANOKIT 2.5GM/VIAL (5GM/KIT) INJECTABLE / INJECTION 2006-12-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022041-001 CYANOKIT 5GM/VIAL (5GM/KIT) INJECTABLE / INJECTION RLD, RS 2011-04-08 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N022041-002 CYANOKIT 2.5GM/VIAL (5GM/KIT) INJECTABLE / INJECTION 2006-12-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022041-001 CYANOKIT 5GM/VIAL (5GM/KIT) INJECTABLE / INJECTION RLD, RS 2011-04-08 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022041-002 CYANOKIT 2.5GM/VIAL (5GM/KIT) INJECTABLE / INJECTION 2006-12-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022041-001 CYANOKIT 5GM/VIAL (5GM/KIT) INJECTABLE / INJECTION RLD, RS 2011-04-08 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022041-002 CYANOKIT 2.5GM/VIAL (5GM/KIT) INJECTABLE / INJECTION 2006-12-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022041-001 CYANOKIT 5GM/VIAL (5GM/KIT) INJECTABLE / INJECTION RLD, RS 2011-04-08 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022041-002 CYANOKIT 2.5GM/VIAL (5GM/KIT) INJECTABLE / INJECTION 2006-12-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022041-001 CYANOKIT 5GM/VIAL (5GM/KIT) INJECTABLE / INJECTION RLD, RS 2011-04-08 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022041-002 CYANOKIT 2.5GM/VIAL (5GM/KIT) INJECTABLE / INJECTION 2006-12-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022041-001 CYANOKIT 5GM/VIAL (5GM/KIT) INJECTABLE / INJECTION RLD, RS 2011-04-08 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N022041-002 CYANOKIT 2.5GM/VIAL (5GM/KIT) INJECTABLE / INJECTION 2006-12-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N022041-001 CYANOKIT 5GM/VIAL (5GM/KIT) INJECTABLE / INJECTION RLD, RS 2011-04-08 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N022041-002 CYANOKIT 2.5GM/VIAL (5GM/KIT) INJECTABLE / INJECTION 2006-12-15 782e0a99824c…
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Hydroxocobalamin ACTIVE INGREDIENT Q40X8H422O CYANOKIT (HYDROXOCOBALAMIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERIDIAN MEDICAL TECHNOLOGIES, INC.] 4 Hydroxocobalamin ACTIVE MOIETY Q40X8H422O CYANOKIT (HYDROXOCOBALAMIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERIDIAN MEDICAL TECHNOLOGIES, INC.] 4 Hydrochloric Acid INACTIVE INGREDIENT QTT17582CB CYANOKIT (HYDROXOCOBALAMIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERIDIAN MEDICAL TECHNOLOGIES, INC.] 4
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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Cyanokit HYDROXOCOBALAMIN BTG INTERNATIONAL INC. d56fcc8d-bd64-46ab-b0c0-2124bd745a6b 2023-04-27 Warnings, Adverse reactions Exact identifier application applno (NDA): 022041 application number: NDA022041
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 11704-370-01 11704037001 1 VIAL, GLASS in 1 CARTON (11704-370-01) > 250 mL in 1 VIAL, GLASS 2011-10-01 2024-05-24 No No Current