Home NDC 63323-044 Cyanocobalamin
Product NDC 63323-044
11-digit product format 633230044
Labeler code 63323
Product ID 63323-044_0a2dc386-15b3-45a3-91d7-80b9cf202c03
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name CYANOCOBALAMIN
Dosage form INJECTION, SOLUTION
Route INTRAMUSCULAR; SUBCUTANEOUS
Labeler Fresenius Kabi USA, LLC
Application ANDA080557
Marketing category ANDA
Marketing start 2000-10-18
Substance CYANOCOBALAMIN
Active strength 1000 ug/mL
Pharmacologic classes Vitamin B 12 [CS], Vitamin B12 [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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A080557-002 CYANOCOBALAMIN CYANOCOBALAMIN 0.1MG/ML INJECTABLE / INJECTION Approved before 1982 A080557-003 VIBISONE CYANOCOBALAMIN 1MG/ML INJECTABLE / INJECTION AP RLD, RS, Approved before 1982
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A080557-003 AP
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 A080557-002 CYANOCOBALAMIN 0.1MG/ML INJECTABLE / INJECTION Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A080557-003 VIBISONE 1MG/ML INJECTABLE / INJECTION AP RLD, RS, Approved before 1982 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A080557-002 CYANOCOBALAMIN 0.1MG/ML INJECTABLE / INJECTION Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A080557-003 VIBISONE 1MG/ML INJECTABLE / INJECTION AP RLD, RS, Approved before 1982 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A080557-002 CYANOCOBALAMIN 0.1MG/ML INJECTABLE / INJECTION Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A080557-003 VIBISONE 1MG/ML INJECTABLE / INJECTION AP RLD, RS, Approved before 1982 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A080557-002 CYANOCOBALAMIN 0.1MG/ML INJECTABLE / INJECTION Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A080557-003 VIBISONE 1MG/ML INJECTABLE / INJECTION AP RLD, RS, Approved before 1982 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A080557-002 CYANOCOBALAMIN 0.1MG/ML INJECTABLE / INJECTION Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A080557-003 VIBISONE 1MG/ML INJECTABLE / INJECTION AP RLD, RS, Approved before 1982 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A080557-002 CYANOCOBALAMIN 0.1MG/ML INJECTABLE / INJECTION Approved before 1982 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A080557-003 VIBISONE 1MG/ML INJECTABLE / INJECTION AP RLD, RS, Approved before 1982 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A080557-002 CYANOCOBALAMIN 0.1MG/ML INJECTABLE / INJECTION Approved before 1982 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A080557-003 VIBISONE 1MG/ML INJECTABLE / INJECTION AP RLD, RS, Approved before 1982 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A080557-002 CYANOCOBALAMIN 0.1MG/ML INJECTABLE / INJECTION Approved before 1982 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A080557-003 VIBISONE 1MG/ML INJECTABLE / INJECTION AP RLD, RS, Approved before 1982 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A080557-002 CYANOCOBALAMIN 0.1MG/ML INJECTABLE / INJECTION Approved before 1982 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A080557-003 VIBISONE 1MG/ML INJECTABLE / INJECTION AP RLD, RS, Approved before 1982 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A080557-002 CYANOCOBALAMIN 0.1MG/ML INJECTABLE / INJECTION Approved before 1982 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A080557-003 VIBISONE 1MG/ML INJECTABLE / INJECTION AP RLD, RS, Approved before 1982 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A080557-002 CYANOCOBALAMIN 0.1MG/ML INJECTABLE / INJECTION Approved before 1982 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A080557-003 VIBISONE 1MG/ML INJECTABLE / INJECTION AP RLD, RS, Approved before 1982 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A080557-002 CYANOCOBALAMIN 0.1MG/ML INJECTABLE / INJECTION Approved before 1982 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A080557-003 VIBISONE 1MG/ML INJECTABLE / INJECTION AP RLD, RS, Approved before 1982 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A080557-002 CYANOCOBALAMIN 0.1MG/ML INJECTABLE / INJECTION Approved before 1982 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A080557-003 VIBISONE 1MG/ML INJECTABLE / INJECTION AP RLD, RS, Approved before 1982 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A080557-002 CYANOCOBALAMIN 0.1MG/ML INJECTABLE / INJECTION Approved before 1982 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A080557-003 VIBISONE 1MG/ML INJECTABLE / INJECTION AP RLD, RS, Approved before 1982 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A080557-002 CYANOCOBALAMIN 0.1MG/ML INJECTABLE / INJECTION Approved before 1982 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A080557-003 VIBISONE 1MG/ML INJECTABLE / INJECTION AP RLD, RS, Approved before 1982 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A080557-002 CYANOCOBALAMIN 0.1MG/ML INJECTABLE / INJECTION Approved before 1982 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A080557-003 VIBISONE 1MG/ML INJECTABLE / INJECTION AP RLD, RS, Approved before 1982 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A080557-002 CYANOCOBALAMIN 0.1MG/ML INJECTABLE / INJECTION Approved before 1982 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A080557-003 VIBISONE 1MG/ML INJECTABLE / INJECTION AP RLD, RS, Approved before 1982 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A080557-002 CYANOCOBALAMIN 0.1MG/ML INJECTABLE / INJECTION Approved before 1982 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A080557-003 VIBISONE 1MG/ML INJECTABLE / INJECTION AP RS, Approved before 1982 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A080557-002 CYANOCOBALAMIN 0.1MG/ML INJECTABLE / INJECTION Approved before 1982 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A080557-003 VIBISONE 1MG/ML INJECTABLE / INJECTION AP RLD, RS, Approved before 1982 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A080557-002 CYANOCOBALAMIN 0.1MG/ML INJECTABLE / INJECTION Approved before 1982 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A080557-003 VIBISONE 1MG/ML INJECTABLE / INJECTION AP RLD, RS, Approved before 1982 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Cyanocobalamin
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CYANOCOBALAMIN 1000 ug/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination P6YC3EG204 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 309594 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63323-044-00 Physicians EZ Use B-12 Compliance 1 mL in 1 VIAL, MULTI-DOSE INJECTION, SOLUTION 1 mL 1000 ug in 1mL 6 63323-044-00 Cyanocobalamin 1 mL in 1 VIAL, MULTI-DOSE INJECTION, SOLUTION 1 4 63323-044-01 Cyanocobalamin 25 in 1 TRAY INJECTION, SOLUTION 25 4 63323-044-41 Cyanocobalamin 1 mL in 1 VIAL, MULTI-DOSE INJECTION, SOLUTION 1 3 63323-044-44 Cyanocobalamin 25 in 1 TRAY INJECTION, SOLUTION 25 3
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Cyanocobalamin ACTIVE INGREDIENT P6YC3EG204 PHYSICIANS EZ USE B-12 COMPLIANCE KIT [MEDCHEM MANUFACTURING INC. DBA ENOVACHEM MANUFACTURING
] 1 CYANOCOBALAMIN ACTIVE INGREDIENT P6YC3EG204 CYANOCOBALAMIN INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC] 1 Isopropyl Alcohol ACTIVE INGREDIENT ND2M416302 PHYSICIANS EZ USE B-12 COMPLIANCE KIT [MEDCHEM MANUFACTURING INC. DBA ENOVACHEM MANUFACTURING
] 1 Cyanocobalamin ACTIVE MOIETY P6YC3EG204 PHYSICIANS EZ USE B-12 COMPLIANCE KIT [MEDCHEM MANUFACTURING INC. DBA ENOVACHEM MANUFACTURING
] 1 CYANOCOBALAMIN ACTIVE MOIETY P6YC3EG204 CYANOCOBALAMIN INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC] 1 Isopropyl Alcohol ACTIVE MOIETY ND2M416302 PHYSICIANS EZ USE B-12 COMPLIANCE KIT [MEDCHEM MANUFACTURING INC. DBA ENOVACHEM MANUFACTURING
] 1 BENZYL ALCOHOL INACTIVE INGREDIENT LKG8494WBH PHYSICIANS EZ USE B-12 COMPLIANCE KIT [MEDCHEM MANUFACTURING INC. DBA ENOVACHEM MANUFACTURING
] 1 BENZYL ALCOHOL INACTIVE INGREDIENT LKG8494WBH CYANOCOBALAMIN INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC] 1 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB PHYSICIANS EZ USE B-12 COMPLIANCE KIT [MEDCHEM MANUFACTURING INC. DBA ENOVACHEM MANUFACTURING
] 1 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB CYANOCOBALAMIN INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC] 1 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X PHYSICIANS EZ USE B-12 COMPLIANCE KIT [MEDCHEM MANUFACTURING INC. DBA ENOVACHEM MANUFACTURING
] 1 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X CYANOCOBALAMIN INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC] 1 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I PHYSICIANS EZ USE B-12 COMPLIANCE KIT [MEDCHEM MANUFACTURING INC. DBA ENOVACHEM MANUFACTURING
] 1 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I CYANOCOBALAMIN INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC] 1 WATER INACTIVE INGREDIENT 059QF0KO0R PHYSICIANS EZ USE B-12 COMPLIANCE KIT [MEDCHEM MANUFACTURING INC. DBA ENOVACHEM MANUFACTURING
] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63323-044 PHYSICIANS EZ USE B-12 COMPLIANCE KIT [ASCLEMED USA, INC.] 6 Current NDC, Legacy NDC 20241008_168f94ea-2faf-4aeb-88a5-8753ad60a1c4.zip 63323-044 CYANOCOBALAMIN INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 4 Current NDC, Legacy NDC, 2 package rows 20250123_acff4ff3-4435-4995-a117-dbfcdf72334a.zip 63323-044 CYANOCOBALAMIN INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 3 Current NDC, Legacy NDC, 2 package rows 20241220_8b1cdee5-3368-40e4-90bf-31a64df1f38a.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 63323-044-00 63323004400 1 mL in 1 VIAL, MULTI-DOSE 1 ml Historical 63323-044-01 63323004401 25 VIAL, MULTI-DOSE in 1 TRAY (63323-044-01) / 1 mL in 1 VIAL, MULTI-DOSE (63323-044-00) 2000-10-18 0000-00-00 No No Current 63323-044-41 63323004441 1 mL in 1 VIAL, MULTI-DOSE 1 ml Historical 63323-044-44 63323004444 25 VIAL, MULTI-DOSE in 1 TRAY (63323-044-44) / 1 mL in 1 VIAL, MULTI-DOSE (63323-044-41) 2000-10-18 0000-00-00 No No Current