Cyanocobalamin

Product NDC: 76420-618
11-digit product format: 764200618
Labeler code: 76420
Product ID: 76420-618_06c9643e-5491-13c4-e063-6394a90aa3e1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cyanocobalamin
Dosage form: INJECTION
Route: INTRAMUSCULAR; SUBCUTANEOUS
Labeler: Asclemed USA, Inc.
Application: ANDA215417
Marketing category: ANDA
Marketing start: 2022-08-03
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
A215417-001	CYANOCOBALAMIN	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP		2022-04-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A215417-001	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.

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	A215417-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2022-04-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215417-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2022-04-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215417-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2022-04-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215417-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2022-04-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215417-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2022-04-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215417-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2022-04-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215417-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2022-04-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215417-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2022-04-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215417-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2022-04-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215417-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2022-04-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215417-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2022-04-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215417-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2022-04-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215417-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2022-04-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215417-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2022-04-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215417-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2022-04-15	`5c6f7cd8ea54…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215417-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2022-04-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215417-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2022-04-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215417-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2022-04-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215417-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2022-04-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215417-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2022-04-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215417-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2022-04-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A215417-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2022-04-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A215417-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2022-04-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A215417-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2022-04-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A215417-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2022-04-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A215417-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2022-04-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A215417-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2022-04-15	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A215417-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2022-04-15	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215417-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2022-04-15	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A215417-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215417-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215417-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215417-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215417-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215417-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215417-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215417-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215417-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215417-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215417-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215417-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215417-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215417-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215417-001	AP	1	`5c6f7cd8ea54…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215417-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215417-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215417-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215417-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215417-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215417-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A215417-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A215417-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A215417-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A215417-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A215417-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A215417-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A215417-001	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215417-001	AP	1	`a50c72e98297…`

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
071f7c95-7243-4014-b336-db8962ac0f75	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
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7	Product name	2	20211025
e4870509-7e28-6f92-f0be-dd3dd889a9cf	Product name	5	20200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cd	Product name	2	20190619
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
d206bb34-ea65-399d-70d9-834f22dc2c18	Product name	3	20170724
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
684ea482-2e8b-14af-5664-b98f1e402036	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
9869efd7-d6dd-0665-5b67-53adbe6ef15e	Product name	1	20140508
b060cc1a-fe47-856b-0b77-4448b5963de8	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
76420-618-25	Cyanocobalamin	1 mL in 1 VIAL, MULTI-DOSE	INJECTION	1		1
76420-618-25	Cyanocobalamin	25 in 1 CARTON	INJECTION	25		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76420-618	CYANOCOBALAMIN INJECTION [ASCLEMED USA, INC.]	1	Current NDC, 2 package rows	20231004_071f7c95-7243-4014-b336-db8962ac0f75.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cyanocobalamin	CYANOCOBALAMIN	SOLA Pharmaceuticals	e559c6c8-2973-77fb-e053-2995a90af43d	2025-12-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215417 application number: ANDA215417
Cyanocobalamin	CYANOCOBALAMIN	Asclemed USA, Inc.	071f7c95-7243-4014-b336-db8962ac0f75	2023-10-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215417 application number: ANDA215417 ndc (product): 76420-618

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	071f7c95-7243-4014-b336-db8962ac0f75	1
309594	vitamin B12 1 MG/ML Injectable Solution	SCD	071f7c95-7243-4014-b336-db8962ac0f75	1
309594	cyanocobalamin 1 MG/ML Injectable Solution	SY	071f7c95-7243-4014-b336-db8962ac0f75	1
309594	cyanocobalamin 1000 MCG/ML Injectable Solution	SY	071f7c95-7243-4014-b336-db8962ac0f75	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
76420-618-25	76420061825	25 VIAL, MULTI-DOSE in 1 CARTON (76420-618-25) / 1 mL in 1 VIAL, MULTI-DOSE	2023-10-03	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cyanocobalamin Injection, USP	Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	2023-10-03	HUMAN PRESCRIPTION DRUG LABEL	1