CYANOCOBALAMIN

Product NDC: 51662-1703
11-digit product format: 516621703
Labeler code: 51662
Product ID: 51662-1703_5a87bc3f-642a-4ba7-e063-6294a90a8ae7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: CYANOCOBALAMIN
Dosage form: INJECTION, SOLUTION
Route: INTRAMUSCULAR; SUBCUTANEOUS
Labeler: HF Acquisition Co LLC, DBA HealthFirst
Application: ANDA209429
Marketing category: ANDA
Marketing start: 2018-12-18
Substance: CYANOCOBALAMIN
Active strength: 1000 ug/mL
Pharmacologic classes: Vitamin B 12 [CS], Vitamin B12 [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A209429-001	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
A209429-001	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 · 43 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
2026-09-14 22:38:34	2026-08	A209429-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2018-12-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209429-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2018-12-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209429-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2018-12-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209429-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2018-12-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209429-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2018-12-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209429-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2018-12-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209429-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2018-12-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209429-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2018-12-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209429-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2018-12-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209429-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2018-12-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209429-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2018-12-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209429-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2018-12-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209429-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2018-12-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209429-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2018-12-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209429-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2018-12-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209429-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2018-12-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209429-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2018-12-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209429-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2018-12-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209429-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2018-12-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209429-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2018-12-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209429-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2018-12-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209429-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2018-12-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209429-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2018-12-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209429-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2018-12-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209429-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2018-12-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209429-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2018-12-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209429-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2018-12-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209429-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2018-12-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209429-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2018-12-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209429-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2018-12-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209429-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2018-12-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209429-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2018-12-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209429-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2018-12-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209429-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2018-12-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209429-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2018-12-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209429-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2018-12-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209429-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2018-12-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209429-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2018-12-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209429-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2018-12-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209429-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2018-12-18	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A209429-001	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209429-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209429-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209429-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209429-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209429-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209429-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209429-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209429-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209429-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209429-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209429-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209429-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209429-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209429-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209429-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209429-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209429-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209429-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209429-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209429-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209429-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209429-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209429-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209429-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209429-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209429-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209429-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209429-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209429-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209429-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209429-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209429-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209429-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209429-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209429-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209429-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209429-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209429-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209429-001	AP	1	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: CYANOCOBALAMIN
Listing expiration: 2027-12-31

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
54f088b1-7cf8-3837-e063-6294a90a88e7	Available on FDA.report

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	HF Acquisition Co LLC, DBA HealthFirst	54f088b1-7cf8-3837-e063-6294a90a88e7	2026-09-02	Adverse reactions	Exact identifier application applno (ANDA): 209429 application number: ANDA209429 ndc (product): 51662-1703
CYANOCOBALAMIN	CYANOCOBALAMIN	Henry Schein, Inc.	ff32f34b-89b3-4617-ad42-2e8bcb88627e	2025-10-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209429 application number: ANDA209429
CYANOCOBALAMIN	CYANOCOBALAMIN	Somerset Therapeutics, LLC	617e44f8-df80-4764-85b9-be0fb6da8db3	2025-08-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209429 application number: ANDA209429

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	Sample	Exclude flag	Status
51662-1703-3	51662170303	10 POUCH in 1 CASE (51662-1703-3) / 1 VIAL in 1 POUCH (51662-1703-2) / 30 mL in 1 VIAL (51662-1703-1)	10 pouch	2018-12-18	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CYANOCOBALAMIN - HF Acquisition Co LLC, DBA HealthFirst	HF Acquisition Co LLC, DBA HealthFirst	2026-09-02	HUMAN PRESCRIPTION DRUG LABEL	2