B12 Inject Kit

Product NDC: 69263-816
11-digit product format: 692630816
Labeler code: 69263
Product ID: 69263-816_68803a2e-9bb9-107d-e053-2a91aa0a5ce4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cyanocobalamin
Dosage form: KIT
Route: INTRAMUSCULAR; SUBCUTANEOUS
Labeler: Oaklock, LLC
Application: ANDA080557
Marketing category: ANDA
Marketing start: 2015-06-19
Marketing end: 0000-00-00
Active strength: 0
NDC exclude flag: No
Listing certified through: 2019-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	69263-816		D	Discontinued by firm		2026-08-11
excluded package	package	69263-816	69263-816-01	D	Discontinued by firm		2026-08-11

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 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	69263-816-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	69263-816-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	69263-816-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	69263-816-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	69263-816-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	69263-816-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	69263-816-01	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	69263-816-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	69263-816-01	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	69263-816-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	69263-816-01	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	69263-816-01	`557ba5c1ecfa…`	`9c80585c8c6e…`

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	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A080557-003	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A080557-003	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A080557-003	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A080557-003	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A080557-003	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A080557-003	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A080557-003	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A080557-003	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A080557-003	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A080557-003	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A080557-003	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A080557-003	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A080557-003	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A080557-003	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A080557-003	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A080557-003	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A080557-003	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A080557-003	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A080557-003	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A080557-003	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A080557-003	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A080557-003	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A080557-003	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A080557-003	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A080557-003	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A080557-003	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A080557-003	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A080557-003	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A080557-003	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A080557-003	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A080557-003	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A080557-003	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A080557-003	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A080557-003	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A080557-003	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A080557-003	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A080557-003	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A080557-003	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A080557-003	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A080557-003	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	Fresenius Kabi USA, LLC	acff4ff3-4435-4995-a117-dbfcdf72334a	2024-12-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080557 application number: ANDA080557
Cyanocobalamin	CYANOCOBALAMIN	Fresenius Kabi USA, LLC	8b1cdee5-3368-40e4-90bf-31a64df1f38a	2024-12-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080557 application number: ANDA080557
Cyanocobalamin	CYANOCOBALAMIN	Asclemed USA, Inc.	66e3441f-79fa-4a1b-be22-2bc683cd7abc	2021-07-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080557 application number: ANDA080557