Home NDC 16714-609-05 cyanocobalamin
Product NDC 16714-609
Requested package NDC 16714-609-05
11-digit product format 167140609
Labeler code 16714
Product ID 16714-609_c98d8fe3-6d83-4525-be4e-6309434efd0e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name cyanocobalamin
Dosage form INJECTION, SOLUTION
Route INTRAMUSCULAR; SUBCUTANEOUS
Labeler Northstar Rx LLC.
Application ANDA214655
Marketing category ANDA
Marketing start 2022-07-18
Marketing end 0000-00-00
Substance CYANOCOBALAMIN
Active strength 1000 ug/mL
Pharmacologic classes Vitamin B 12 [CS], Vitamin B12 [EPC]
NDC exclude flag No
Listing certified through 2023-12-31
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 · 11 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…
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 A214655-001 CYANOCOBALAMIN CYANOCOBALAMIN 1MG/ML INJECTABLE / INJECTION AP 2022-04-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A214655-001 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 A214655-001 CYANOCOBALAMIN 1MG/ML INJECTABLE / INJECTION AP 2022-04-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214655-001 CYANOCOBALAMIN 1MG/ML INJECTABLE / INJECTION AP 2022-04-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A214655-001 CYANOCOBALAMIN 1MG/ML INJECTABLE / INJECTION AP 2022-04-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214655-001 CYANOCOBALAMIN 1MG/ML INJECTABLE / INJECTION AP 2022-04-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214655-001 CYANOCOBALAMIN 1MG/ML INJECTABLE / INJECTION AP 2022-04-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214655-001 CYANOCOBALAMIN 1MG/ML INJECTABLE / INJECTION AP 2022-04-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214655-001 CYANOCOBALAMIN 1MG/ML INJECTABLE / INJECTION AP 2022-04-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214655-001 CYANOCOBALAMIN 1MG/ML INJECTABLE / INJECTION AP 2022-04-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214655-001 CYANOCOBALAMIN 1MG/ML INJECTABLE / INJECTION AP 2022-04-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A214655-001 CYANOCOBALAMIN 1MG/ML INJECTABLE / INJECTION AP 2022-04-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214655-001 CYANOCOBALAMIN 1MG/ML INJECTABLE / INJECTION AP 2022-04-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214655-001 CYANOCOBALAMIN 1MG/ML INJECTABLE / INJECTION AP 2022-04-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A214655-001 CYANOCOBALAMIN 1MG/ML INJECTABLE / INJECTION AP 2022-04-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A214655-001 CYANOCOBALAMIN 1MG/ML INJECTABLE / INJECTION AP 2022-04-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A214655-001 CYANOCOBALAMIN 1MG/ML INJECTABLE / INJECTION AP 2022-04-15 5c6f7cd8ea54…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A214655-001 CYANOCOBALAMIN 1MG/ML INJECTABLE / INJECTION AP 2022-04-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A214655-001 CYANOCOBALAMIN 1MG/ML INJECTABLE / INJECTION AP 2022-04-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A214655-001 CYANOCOBALAMIN 1MG/ML INJECTABLE / INJECTION AP 2022-04-15 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A214655-001 CYANOCOBALAMIN 1MG/ML INJECTABLE / INJECTION AP 2022-04-15 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A214655-001 CYANOCOBALAMIN 1MG/ML INJECTABLE / INJECTION AP 2022-04-15 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A214655-001 CYANOCOBALAMIN 1MG/ML INJECTABLE / INJECTION AP 2022-04-15 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A214655-001 CYANOCOBALAMIN 1MG/ML INJECTABLE / INJECTION AP 2022-04-15 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A214655-001 CYANOCOBALAMIN 1MG/ML INJECTABLE / INJECTION AP 2022-04-15 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A214655-001 CYANOCOBALAMIN 1MG/ML INJECTABLE / INJECTION AP 2022-04-15 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A214655-001 CYANOCOBALAMIN 1MG/ML INJECTABLE / INJECTION AP 2022-04-15 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A214655-001 CYANOCOBALAMIN 1MG/ML INJECTABLE / INJECTION AP 2022-04-15 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A214655-001 CYANOCOBALAMIN 1MG/ML INJECTABLE / INJECTION AP 2022-04-15 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A214655-001 CYANOCOBALAMIN 1MG/ML INJECTABLE / INJECTION AP 2022-04-15 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A214655-001 CYANOCOBALAMIN 1MG/ML INJECTABLE / INJECTION AP 2022-04-15 a50c72e98297…
Observed Orange Book normalized TE history# 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 · 2 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 16714-609-05 16714060905 5 VIAL, MULTI-DOSE in 1 CARTON (16714-609-05) > 30 mL in 1 VIAL, MULTI-DOSE (16714-609-01) 2022-07-18 0000-00-00 No No Current