Home NDC 68083-561 cyanocobalamin
Product NDC 68083-561
11-digit product format 680830561
Labeler code 68083
Product ID 68083-561_771cf601-8f92-4e4f-a29f-b18e71b1ba96
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name cyanocobalamin
Dosage form INJECTION
Route INTRAMUSCULAR; SUBCUTANEOUS
Labeler Gland Pharma Limited
Application ANDA214390
Marketing category ANDA
Marketing start 2022-10-14
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A214390-001 CYANOCOBALAMIN CYANOCOBALAMIN 1MG/ML INJECTABLE / INJECTION AP 2020-09-24
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A214390-001 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.
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 A214390-001 CYANOCOBALAMIN 1MG/ML INJECTABLE / INJECTION AP 2020-09-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214390-001 CYANOCOBALAMIN 1MG/ML INJECTABLE / INJECTION AP 2020-09-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A214390-001 CYANOCOBALAMIN 1MG/ML INJECTABLE / INJECTION AP 2020-09-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214390-001 CYANOCOBALAMIN 1MG/ML INJECTABLE / INJECTION AP 2020-09-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214390-001 CYANOCOBALAMIN 1MG/ML INJECTABLE / INJECTION AP 2020-09-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214390-001 CYANOCOBALAMIN 1MG/ML INJECTABLE / INJECTION AP 2020-09-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214390-001 CYANOCOBALAMIN 1MG/ML INJECTABLE / INJECTION AP 2020-09-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214390-001 CYANOCOBALAMIN 1MG/ML INJECTABLE / INJECTION AP 2020-09-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214390-001 CYANOCOBALAMIN 1MG/ML INJECTABLE / INJECTION AP 2020-09-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A214390-001 CYANOCOBALAMIN 1MG/ML INJECTABLE / INJECTION AP 2020-09-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214390-001 CYANOCOBALAMIN 1MG/ML INJECTABLE / INJECTION AP 2020-09-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214390-001 CYANOCOBALAMIN 1MG/ML INJECTABLE / INJECTION AP 2020-09-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A214390-001 CYANOCOBALAMIN 1MG/ML INJECTABLE / INJECTION AP 2020-09-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A214390-001 CYANOCOBALAMIN 1MG/ML INJECTABLE / INJECTION AP 2020-09-24 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A214390-001 CYANOCOBALAMIN 1MG/ML INJECTABLE / INJECTION AP 2020-09-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A214390-001 CYANOCOBALAMIN 1MG/ML INJECTABLE / INJECTION AP 2020-09-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A214390-001 CYANOCOBALAMIN 1MG/ML INJECTABLE / INJECTION AP 2020-09-24 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A214390-001 CYANOCOBALAMIN 1MG/ML INJECTABLE / INJECTION AP 2020-09-24 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A214390-001 CYANOCOBALAMIN 1MG/ML INJECTABLE / INJECTION AP 2020-09-24 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A214390-001 CYANOCOBALAMIN 1MG/ML INJECTABLE / INJECTION AP 2020-09-24 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A214390-001 CYANOCOBALAMIN 1MG/ML INJECTABLE / INJECTION AP 2020-09-24 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A214390-001 CYANOCOBALAMIN 1MG/ML INJECTABLE / INJECTION AP 2020-09-24 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A214390-001 CYANOCOBALAMIN 1MG/ML INJECTABLE / INJECTION AP 2020-09-24 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A214390-001 CYANOCOBALAMIN 1MG/ML INJECTABLE / INJECTION AP 2020-09-24 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A214390-001 CYANOCOBALAMIN 1MG/ML INJECTABLE / INJECTION AP 2020-09-24 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A214390-001 CYANOCOBALAMIN 1MG/ML INJECTABLE / INJECTION AP 2020-09-24 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A214390-001 CYANOCOBALAMIN 1MG/ML INJECTABLE / INJECTION AP 2020-09-24 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A214390-001 CYANOCOBALAMIN 1MG/ML INJECTABLE / INJECTION AP 2020-09-24 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A214390-001 CYANOCOBALAMIN 1MG/ML INJECTABLE / INJECTION AP 2020-09-24 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A214390-001 CYANOCOBALAMIN 1MG/ML INJECTABLE / INJECTION AP 2020-09-24 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A214390-001 CYANOCOBALAMIN 1MG/ML INJECTABLE / INJECTION AP 2020-09-24 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A214390-001 CYANOCOBALAMIN 1MG/ML INJECTABLE / INJECTION AP 2020-09-24 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A214390-001 CYANOCOBALAMIN 1MG/ML INJECTABLE / INJECTION AP 2020-09-24 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A214390-001 CYANOCOBALAMIN 1MG/ML INJECTABLE / INJECTION AP 2020-09-24 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A214390-001 CYANOCOBALAMIN 1MG/ML INJECTABLE / INJECTION AP 2020-09-24 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A214390-001 CYANOCOBALAMIN 1MG/ML INJECTABLE / INJECTION AP 2020-09-24 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A214390-001 CYANOCOBALAMIN 1MG/ML INJECTABLE / INJECTION AP 2020-09-24 a50c72e98297…
Observed Orange Book normalized TE history# 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 68083-561-25 cyanocobalamin 25 in 1 CARTON INJECTION 25 5 68083-561-25 cyanocobalamin 10 mL in 1 VIAL, MULTI-DOSE INJECTION 10 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68083-561 CYANOCOBALAMIN INJECTION CYANOCOBALAMIN INJECTION [GLAND PHARMA LIMITED] 5 Current NDC, Legacy NDC, 2 package rows 20221104_cd8d188a-fa5d-4580-bcb1-ac8617118cbb.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 · 4 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 68083-561-25 68083056125 25 VIAL, MULTI-DOSE in 1 CARTON (68083-561-25) / 10 mL in 1 VIAL, MULTI-DOSE 2022-10-14 0000-00-00 No No Current