Home NDC 43386-237 Cyanocobalamin
Product NDC 43386-237
11-digit product format 433860237
Labeler code 43386
Product ID 43386-237_bb7b94e1-b5cd-486f-9e34-38fc9595547a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Cyanocobalamin
Dosage form SPRAY, METERED
Route NASAL
Labeler Lupin Pharmaceuticals,Inc.
Application ANDA210629
Marketing category ANDA
Marketing start 2024-01-29
Substance CYANOCOBALAMIN
Active strength 500 ug/1
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 A210629-001 CYANOCOBALAMIN CYANOCOBALAMIN 0.5MG/SPRAY SPRAY, METERED / NASAL AB 2023-06-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A210629-001 AB
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 A210629-001 CYANOCOBALAMIN 0.5MG/SPRAY SPRAY, METERED / NASAL AB 2023-06-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210629-001 CYANOCOBALAMIN 0.5MG/SPRAY SPRAY, METERED / NASAL AB 2023-06-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210629-001 CYANOCOBALAMIN 0.5MG/SPRAY SPRAY, METERED / NASAL AB 2023-06-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210629-001 CYANOCOBALAMIN 0.5MG/SPRAY SPRAY, METERED / NASAL AB 2023-06-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210629-001 CYANOCOBALAMIN 0.5MG/SPRAY SPRAY, METERED / NASAL AB 2023-06-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210629-001 CYANOCOBALAMIN 0.5MG/SPRAY SPRAY, METERED / NASAL AB 2023-06-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210629-001 CYANOCOBALAMIN 0.5MG/SPRAY SPRAY, METERED / NASAL AB 2023-06-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210629-001 CYANOCOBALAMIN 0.5MG/SPRAY SPRAY, METERED / NASAL AB 2023-06-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210629-001 CYANOCOBALAMIN 0.5MG/SPRAY SPRAY, METERED / NASAL AB 2023-06-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A210629-001 CYANOCOBALAMIN 0.5MG/SPRAY SPRAY, METERED / NASAL AB 2023-06-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210629-001 CYANOCOBALAMIN 0.5MG/SPRAY SPRAY, METERED / NASAL AB 2023-06-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210629-001 CYANOCOBALAMIN 0.5MG/SPRAY SPRAY, METERED / NASAL AB 2023-06-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210629-001 CYANOCOBALAMIN 0.5MG/SPRAY SPRAY, METERED / NASAL AB 2023-06-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A210629-001 CYANOCOBALAMIN 0.5MG/SPRAY SPRAY, METERED / NASAL AB 2023-06-30 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A210629-001 CYANOCOBALAMIN 0.5MG/SPRAY SPRAY, METERED / NASAL AB 2023-06-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A210629-001 CYANOCOBALAMIN 0.5MG/SPRAY SPRAY, METERED / NASAL AB 2023-06-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A210629-001 CYANOCOBALAMIN 0.5MG/SPRAY SPRAY, METERED / NASAL AB 2023-06-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A210629-001 CYANOCOBALAMIN 0.5MG/SPRAY SPRAY, METERED / NASAL AB 2023-06-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A210629-001 CYANOCOBALAMIN 0.5MG/SPRAY SPRAY, METERED / NASAL AB 2023-06-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A210629-001 CYANOCOBALAMIN 0.5MG/SPRAY SPRAY, METERED / NASAL AB 2023-06-30 a67488948f0b…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A210629-001 CYANOCOBALAMIN 0.5MG/SPRAY SPRAY, METERED / NASAL AB 2023-06-30 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 500 ug/1
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 861113 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 43386-237-60 Cyanocobalamin 1 in 1 BLISTER PACK SPRAY, METERED 1 4 43386-237-70 Cyanocobalamin 4 in 1 CARTON SPRAY, METERED 4 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43386-237 CYANOCOBALAMIN SPRAY, METERED [LUPIN PHARMACEUTICALS,INC.] 4 Current NDC, 2 package rows 20240202_efb7dc02-f0c9-4537-9e23-b641c428068c.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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 43386-237-60 43386023760 1 CARTON in 1 BLISTER PACK (43386-237-60) / 4 SPRAY, METERED in 1 CARTON (43386-237-70) 1 carton 2024-01-29 No No Current 43386-237-70 43386023770 4 in 1 CARTON Historical