Cyanocobalamin

Product NDC: 72843-487
11-digit product format: 728430487
Labeler code: 72843
Product ID: 72843-487_cd1a0328-1f92-55ef-e053-2995a90a8355
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cyanocobalamin
Dosage form: INJECTION, SOLUTION
Route: INTRAMUSCULAR
Labeler: UBI Pharma Inc.
Application: ANDA209255
Marketing category: ANDA
Marketing start: 2019-01-02
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: 2022-12-31
Current FDA listing: Historical FDA.report record

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
A209255-001	CYANOCOBALAMIN	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP		2018-12-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209255-001	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.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A209255-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2018-12-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209255-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2018-12-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209255-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2018-12-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209255-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2018-12-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209255-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2018-12-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209255-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2018-12-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209255-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2018-12-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209255-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2018-12-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209255-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2018-12-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209255-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2018-12-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209255-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2018-12-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209255-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2018-12-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209255-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2018-12-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209255-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2018-12-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209255-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2018-12-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209255-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2018-12-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209255-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2018-12-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209255-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2018-12-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209255-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2018-12-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209255-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2018-12-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209255-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2018-12-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209255-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2018-12-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209255-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2018-12-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209255-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2018-12-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209255-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2018-12-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209255-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2018-12-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209255-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2018-12-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209255-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2018-12-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209255-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2018-12-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209255-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2018-12-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209255-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2018-12-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209255-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2018-12-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209255-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2018-12-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209255-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2018-12-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209255-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2018-12-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209255-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2018-12-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209255-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2018-12-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209255-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2018-12-18	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209255-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2018-12-18	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209255-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2018-12-18	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A209255-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209255-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209255-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209255-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209255-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209255-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209255-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209255-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209255-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209255-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209255-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209255-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209255-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209255-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209255-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209255-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209255-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209255-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209255-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209255-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209255-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209255-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209255-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209255-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209255-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209255-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209255-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209255-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209255-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209255-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209255-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209255-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209255-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209255-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209255-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209255-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209255-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209255-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209255-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209255-001	AP	1	`cb3db0bc1861…`

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cyanocobalamin	CYANOCOBALAMIN	A-S Medication Solutions	a61181f5-7e2d-45f9-929a-cb8bc70c992e	2026-01-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209255 application number: ANDA209255
Cyanocobalamin	CYANOCOBALAMIN	Henry Schein, Inc.	92f08572-cfd9-4a99-bb49-937ab94eeb62	2025-09-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209255 application number: ANDA209255
Cyanocobalamin	CYANOCOBALAMIN	Vitruvias Therapeutics	2117af8a-723f-4e2f-98a6-83ad2c423751	2024-12-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209255 application number: ANDA209255

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
P6YC3EG204	CYANOCOBALAMIN	68-19-9	CYANOCOBALAMIN

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
72843-487-10	72843048710	10 VIAL in 1 BOX (72843-487-10) > 1 mL in 1 VIAL (72843-487-01)	10 vial	2019-06-15	0000-00-00	No	No	Current
72843-487-25	72843048725	25 VIAL in 1 BOX (72843-487-25) > 1 mL in 1 VIAL (72843-487-01)	25 vial	2019-01-02	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cyanocobalamin Injection USP 1000 mcg/mL	UBI Pharma Inc. \| United Biomedical Inc Pharma	2021-10-12	HUMAN PRESCRIPTION DRUG LABEL	3