Cyanocobalamin

Product NDC
50090-6229
11-digit product format
500906229
Labeler code
50090
Product ID
50090-6229_216c7e8c-0229-42a8-9551-3cd0ba1a5b62
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyanocobalamin
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR
Labeler
A-S Medication Solutions
Application
ANDA209255
Marketing category
ANDA
Marketing start
2019-01-02
Substance
CYANOCOBALAMIN
Active strength
1000 ug/mL
Pharmacologic classes
Vitamin B 12 [CS], Vitamin B12 [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A209255-001CYANOCOBALAMINCYANOCOBALAMIN1MG/MLINJECTABLE / INJECTIONAP2018-12-18

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A209255-001AP

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 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A209255-001CYANOCOBALAMIN1MG/MLINJECTABLE / INJECTIONAP2018-12-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209255-001CYANOCOBALAMIN1MG/MLINJECTABLE / INJECTIONAP2018-12-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A209255-001CYANOCOBALAMIN1MG/MLINJECTABLE / INJECTIONAP2018-12-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209255-001CYANOCOBALAMIN1MG/MLINJECTABLE / INJECTIONAP2018-12-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209255-001CYANOCOBALAMIN1MG/MLINJECTABLE / INJECTIONAP2018-12-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209255-001CYANOCOBALAMIN1MG/MLINJECTABLE / INJECTIONAP2018-12-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209255-001CYANOCOBALAMIN1MG/MLINJECTABLE / INJECTIONAP2018-12-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209255-001CYANOCOBALAMIN1MG/MLINJECTABLE / INJECTIONAP2018-12-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209255-001CYANOCOBALAMIN1MG/MLINJECTABLE / INJECTIONAP2018-12-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209255-001CYANOCOBALAMIN1MG/MLINJECTABLE / INJECTIONAP2018-12-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209255-001CYANOCOBALAMIN1MG/MLINJECTABLE / INJECTIONAP2018-12-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209255-001CYANOCOBALAMIN1MG/MLINJECTABLE / INJECTIONAP2018-12-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209255-001CYANOCOBALAMIN1MG/MLINJECTABLE / INJECTIONAP2018-12-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05A209255-001CYANOCOBALAMIN1MG/MLINJECTABLE / INJECTIONAP2018-12-188072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209255-001CYANOCOBALAMIN1MG/MLINJECTABLE / INJECTIONAP2018-12-185c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A209255-001CYANOCOBALAMIN1MG/MLINJECTABLE / INJECTIONAP2018-12-185d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A209255-001CYANOCOBALAMIN1MG/MLINJECTABLE / INJECTIONAP2018-12-184b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A209255-001CYANOCOBALAMIN1MG/MLINJECTABLE / INJECTIONAP2018-12-1874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A209255-001CYANOCOBALAMIN1MG/MLINJECTABLE / INJECTIONAP2018-12-18bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A209255-001CYANOCOBALAMIN1MG/MLINJECTABLE / INJECTIONAP2018-12-18782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A209255-001CYANOCOBALAMIN1MG/MLINJECTABLE / INJECTIONAP2018-12-1887673890dc5c…
2021-03-12 10:30 UTC2021-03A209255-001CYANOCOBALAMIN1MG/MLINJECTABLE / INJECTIONAP2018-12-185aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A209255-001CYANOCOBALAMIN1MG/MLINJECTABLE / INJECTIONAP2018-12-188869cabd3fbd…
2020-11-12 02:37 UTC2020-11A209255-001CYANOCOBALAMIN1MG/MLINJECTABLE / INJECTIONAP2018-12-18c0c555d07b60…
2019-12-14 00:12 UTC2019-12A209255-001CYANOCOBALAMIN1MG/MLINJECTABLE / INJECTIONAP2018-12-183f01610625f2…
2019-09-15 20:21 UTC2019-09A209255-001CYANOCOBALAMIN1MG/MLINJECTABLE / INJECTIONAP2018-12-18b00525d2431f…
2019-07-19 19:46 UTC2019-07A209255-001CYANOCOBALAMIN1MG/MLINJECTABLE / INJECTIONAP2018-12-18ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A209255-001CYANOCOBALAMIN1MG/MLINJECTABLE / INJECTIONAP2018-12-186a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A209255-001CYANOCOBALAMIN1MG/MLINJECTABLE / INJECTIONAP2018-12-181c564ffb4f44…
2023-12-20 04:57 UTC2023-12A209255-001CYANOCOBALAMIN1MG/MLINJECTABLE / INJECTIONAP2018-12-18ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A209255-001CYANOCOBALAMIN1MG/MLINJECTABLE / INJECTIONAP2018-12-18a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A209255-001CYANOCOBALAMIN1MG/MLINJECTABLE / INJECTIONAP2018-12-189b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A209255-001CYANOCOBALAMIN1MG/MLINJECTABLE / INJECTIONAP2018-12-18a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A209255-001CYANOCOBALAMIN1MG/MLINJECTABLE / INJECTIONAP2018-12-183f0d92c62455…
2023-05-13 08:27 UTC2023-05A209255-001CYANOCOBALAMIN1MG/MLINJECTABLE / INJECTIONAP2018-12-18053a50430f4f…
2023-01-26 05:58 UTC2023-01A209255-001CYANOCOBALAMIN1MG/MLINJECTABLE / INJECTIONAP2018-12-183bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A209255-001CYANOCOBALAMIN1MG/MLINJECTABLE / INJECTIONAP2018-12-183a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A209255-001CYANOCOBALAMIN1MG/MLINJECTABLE / INJECTIONAP2018-12-18f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A209255-001CYANOCOBALAMIN1MG/MLINJECTABLE / INJECTIONAP2018-12-18e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A209255-001CYANOCOBALAMIN1MG/MLINJECTABLE / INJECTIONAP2018-12-18cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A209255-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209255-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A209255-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209255-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209255-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209255-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209255-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209255-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209255-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209255-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209255-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209255-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209255-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A209255-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209255-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A209255-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A209255-001AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A209255-001AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A209255-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A209255-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A209255-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A209255-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A209255-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A209255-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A209255-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09A209255-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A209255-001AP1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A209255-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A209255-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A209255-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A209255-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A209255-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A209255-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A209255-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05A209255-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01A209255-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A209255-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A209255-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A209255-001AP1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A209255-001AP1cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
Cyanocobalamin
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CYANOCOBALAMIN1000 ug/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
P6YC3EG204Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
309594Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a61181f5-7e2d-45f9-929a-cb8bc70c992eAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b82b4008-22fd-05f5-6cc6-c0a6e81c65b8Product name220240805
d206bb34-ea65-399d-70d9-834f22dc2c18Product name320170724

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-6229-0Cyanocobalamin25 in 1 BOXINJECTION, SOLUTION256
50090-6229-0Cyanocobalamin1 mL in 1 VIALINJECTION, SOLUTION16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6229-0ML - Milliliter50090-6229c6315e11-f086-4366-ac60-1201c8d0742512022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6229CYANOCOBALAMIN INJECTION, SOLUTION [A-S MEDICATION SOLUTIONS]3Current NDC, Legacy NDC, 2 package rows20231026_a61181f5-7e2d-45f9-929a-cb8bc70c992e.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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CyanocobalaminCYANOCOBALAMINA-S Medication Solutionsa61181f5-7e2d-45f9-929a-cb8bc70c992e2026-01-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209255
application number: ANDA209255
ndc (product): 50090-6229
CyanocobalaminCYANOCOBALAMINHenry Schein, Inc.92f08572-cfd9-4a99-bb49-937ab94eeb622025-09-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209255
application number: ANDA209255
CyanocobalaminCYANOCOBALAMINVitruvias Therapeutics2117af8a-723f-4e2f-98a6-83ad2c4237512024-12-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209255
application number: ANDA209255

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309594cyanocobalamin 1000 MCG/ML Injectable SolutionPSNa61181f5-7e2d-45f9-929a-cb8bc70c992e6
309594vitamin B12 1 MG/ML Injectable SolutionSCDa61181f5-7e2d-45f9-929a-cb8bc70c992e6
309594cyanocobalamin 1 MG/ML Injectable SolutionSYa61181f5-7e2d-45f9-929a-cb8bc70c992e6
309594cyanocobalamin 1000 MCG/ML Injectable SolutionSYa61181f5-7e2d-45f9-929a-cb8bc70c992e6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-6229-05009062290025 VIAL in 1 BOX (50090-6229-0) / 1 mL in 1 VIAL25 vial2022-11-170000-00-00NoNoCurrent