Cyanocobalamin

Product NDC: 68001-542
11-digit product format: 680010542
Labeler code: 68001
Product ID: 68001-542_fab6a2d8-d9a0-2f8f-e053-6394a90a22bc
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cyanocobalamin
Dosage form: INJECTION, SOLUTION
Route: SUBCUTANEOUS
Labeler: BluePoint Laboratories
Application: ANDA080737
Marketing category: ANDA
Marketing start: 2022-06-24
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
A080737-001	CYANOCOBALAMIN	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
A080737-001	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	RLD / RS	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A080737-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A080737-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A080737-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A080737-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A080737-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A080737-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A080737-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A080737-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A080737-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A080737-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A080737-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A080737-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A080737-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A080737-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A080737-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A080737-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A080737-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A080737-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A080737-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A080737-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A080737-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A080737-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A080737-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A080737-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A080737-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A080737-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A080737-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A080737-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A080737-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A080737-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A080737-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A080737-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A080737-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A080737-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A080737-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A080737-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A080737-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A080737-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A080737-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A080737-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`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	A080737-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A080737-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A080737-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A080737-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A080737-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A080737-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A080737-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A080737-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A080737-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A080737-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A080737-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A080737-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A080737-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A080737-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A080737-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A080737-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A080737-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A080737-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A080737-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A080737-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A080737-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A080737-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A080737-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A080737-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A080737-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A080737-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A080737-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A080737-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A080737-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A080737-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A080737-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A080737-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A080737-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A080737-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A080737-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A080737-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A080737-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A080737-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A080737-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A080737-001	AP	1	`cb3db0bc1861…`

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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
cdd4fd12-e214-43a6-b560-d56fc0d87190	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
b82b4008-22fd-05f5-6cc6-c0a6e81c65b8	Product name	2	20240805
d206bb34-ea65-399d-70d9-834f22dc2c18	Product name	3	20170724

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68001-542-59	Cyanocobalamin	1 mL in 1 VIAL, MULTI-DOSE	INJECTION, SOLUTION	1		2
68001-542-60	Cyanocobalamin	25 in 1 TRAY	INJECTION, SOLUTION	25		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68001-542-59	ML - Milliliter	68001-542	90ed8af4-f26f-4c6a-8c76-74fd5396701f	1	2022-09-12
68001-542-60	ML - Milliliter	68001-542	c324638e-82c4-4d3c-9792-04abf916d2a8	1	2022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68001-542	CYANOCOBALAMIN INJECTION, SOLUTION [BLUEPOINT LABORATORIES]	2	Current NDC, Legacy NDC, 2 package rows	20230506_cdd4fd12-e214-43a6-b560-d56fc0d87190.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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CYANOCOBALAMIN	CYANOCOBALAMIN	HF Acquisition Co LLC, DBA HealthFirst	9d4ac337-5f4d-ef47-e053-2a95a90a6dbf	2025-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080737 application number: ANDA080737
CYANOCOBALAMIN	CYANOCOBALAMIN	HF Acquisition Co LLC, DBA HealthFirst	15c4de10-c059-8c2f-e063-6394a90a03a3	2024-04-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080737 application number: ANDA080737
Cyanocobalamin	CYANOCOBALAMIN	American Regent, Inc.	2fb653d6-e2b2-4969-831b-c0dc37b9c0cc	2023-10-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080737 application number: ANDA080737
Cyanocobalamin	CYANOCOBALAMIN	BluePoint Laboratories	cdd4fd12-e214-43a6-b560-d56fc0d87190	2023-05-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080737 application number: ANDA080737 ndc (product): 68001-542

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
309594	cyanocobalamin 1000 MCG/ML Injectable Solution	PSN	cdd4fd12-e214-43a6-b560-d56fc0d87190	2
309594	vitamin B12 1 MG/ML Injectable Solution	SCD	cdd4fd12-e214-43a6-b560-d56fc0d87190	2
309594	cyanocobalamin 1 MG/ML Injectable Solution	SY	cdd4fd12-e214-43a6-b560-d56fc0d87190	2
309594	cyanocobalamin 1000 MCG/ML Injectable Solution	SY	cdd4fd12-e214-43a6-b560-d56fc0d87190	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68001-542-59	68001054259	1 mL in 1 VIAL, MULTI-DOSE	1 ml					Historical
68001-542-60	68001054260	25 VIAL, MULTI-DOSE in 1 TRAY (68001-542-60) / 1 mL in 1 VIAL, MULTI-DOSE (68001-542-59)		2022-06-24	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CYANOCOBALAMIN INJECTION, USP	BluePoint Laboratories \| American Regent, Inc.	2023-05-05	HUMAN PRESCRIPTION DRUG LABEL	2