Cyanocobalamin

Product NDC: 71288-303
11-digit product format: 712880303
Labeler code: 71288
Product ID: 71288-303_65f0f72b-691f-4cbb-a5d7-7579a133f457
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cyanocobalamin
Dosage form: INJECTION
Route: INTRAMUSCULAR; SUBCUTANEOUS
Labeler: Meitheal Pharmaceuticals Inc.
Application: ANDA214390
Marketing category: ANDA
Marketing start: 2020-09-24
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
A214390-001	CYANOCOBALAMIN	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP		2020-09-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A214390-001	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	A214390-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2020-09-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214390-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2020-09-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214390-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2020-09-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214390-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2020-09-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214390-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2020-09-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214390-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2020-09-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214390-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2020-09-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214390-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2020-09-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214390-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2020-09-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214390-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2020-09-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214390-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2020-09-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214390-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2020-09-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214390-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2020-09-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214390-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2020-09-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214390-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2020-09-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A214390-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2020-09-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A214390-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2020-09-24	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A214390-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2020-09-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A214390-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2020-09-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A214390-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2020-09-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A214390-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2020-09-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A214390-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2020-09-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A214390-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2020-09-24	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214390-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2020-09-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214390-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2020-09-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214390-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2020-09-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214390-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2020-09-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214390-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2020-09-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A214390-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2020-09-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A214390-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2020-09-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A214390-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2020-09-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A214390-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2020-09-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A214390-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2020-09-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A214390-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2020-09-24	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A214390-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2020-09-24	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A214390-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2020-09-24	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214390-001	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	2020-09-24	`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	A214390-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214390-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214390-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214390-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214390-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214390-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214390-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214390-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214390-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214390-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214390-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214390-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214390-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214390-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214390-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A214390-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A214390-001	AP	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A214390-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A214390-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A214390-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A214390-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A214390-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A214390-001	AP	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214390-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214390-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214390-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214390-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214390-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A214390-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A214390-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A214390-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A214390-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A214390-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A214390-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A214390-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A214390-001	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214390-001	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
ccf5b124-083d-4465-a666-c1bc6e84d630	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	SPL version
71288-303-01	Cyanocobalamin	1 mL in 1 VIAL, MULTI-DOSE	INJECTION	1	1
71288-303-02	Cyanocobalamin	25 in 1 CARTON	INJECTION	25	1
71288-303-91	Cyanocobalamin	1 mL in 1 VIAL, MULTI-DOSE	INJECTION	1	1
71288-303-92	Cyanocobalamin	25 in 1 CARTON	INJECTION	25	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71288-303-01	ML - Milliliter	71288-303	93bb602e-8f2c-4224-b092-73a5b1c5e675	1	2022-10-06
71288-303-02	ML - Milliliter	71288-303	781330bf-6559-4a3c-ba2a-f7fa54cb06dc	1	2022-10-06
71288-303-91	ML - Milliliter	71288-303	120fa682-0441-45a4-b22c-1b140b23d3d1	1	2024-09-09
71288-303-92	ML - Milliliter	71288-303	b00a1d75-7fda-447e-b43d-2ffd23158f6a	1	2024-09-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71288-303	CYANOCOBALAMIN INJECTION [MEITHEAL PHARMACEUTICALS INC.]	1	Current NDC, Legacy NDC, 2 package rows	20240606_c6436212-9246-4e29-8540-9af992b667eb.zip
71288-303	CYANOCOBALAMIN INJECTION [MEITHEAL PHARMACEUTICALS INC.]	1	Current NDC, Legacy NDC, 2 package rows	20220517_ccf5b124-083d-4465-a666-c1bc6e84d630.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	Plano Pharmaceuticals Inc.	4cbc05f6-4b31-4a5f-e063-6394a90a676c	2026-03-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214390 application number: ANDA214390
Cyanocobalamin	CYANOCOBALAMIN	Meitheal Pharmaceuticals Inc.	c6436212-9246-4e29-8540-9af992b667eb	2024-06-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214390 application number: ANDA214390 ndc (product): 71288-303
Cyanocobalamin	CYANOCOBALAMIN	Gland Pharma Limited	cd8d188a-fa5d-4580-bcb1-ac8617118cbb	2022-11-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214390 application number: ANDA214390
Cyanocobalamin	CYANOCOBALAMIN	Meitheal Pharmaceuticals Inc.	ccf5b124-083d-4465-a666-c1bc6e84d630	2022-04-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214390 application number: ANDA214390 ndc (product): 71288-303

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	c6436212-9246-4e29-8540-9af992b667eb	1
309594	cyanocobalamin 1000 MCG/ML Injectable Solution	PSN	ccf5b124-083d-4465-a666-c1bc6e84d630	1
309594	vitamin B12 1 MG/ML Injectable Solution	SCD	c6436212-9246-4e29-8540-9af992b667eb	1
309594	vitamin B12 1 MG/ML Injectable Solution	SCD	ccf5b124-083d-4465-a666-c1bc6e84d630	1
309594	cyanocobalamin 1 MG/ML Injectable Solution	SY	c6436212-9246-4e29-8540-9af992b667eb	1
309594	cyanocobalamin 1 MG/ML Injectable Solution	SY	ccf5b124-083d-4465-a666-c1bc6e84d630	1
309594	cyanocobalamin 1000 MCG/ML Injectable Solution	SY	c6436212-9246-4e29-8540-9af992b667eb	1
309594	cyanocobalamin 1000 MCG/ML Injectable Solution	SY	ccf5b124-083d-4465-a666-c1bc6e84d630	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71288-303-01	71288030301	1 mL in 1 VIAL, MULTI-DOSE	1 ml					Historical
71288-303-02	71288030302	25 VIAL, MULTI-DOSE in 1 CARTON (71288-303-02) / 1 mL in 1 VIAL, MULTI-DOSE (71288-303-01)		2020-09-24	0000-00-00	No	No	Current
71288-303-91	71288030391	1 mL in 1 VIAL, MULTI-DOSE	1 ml					Historical
71288-303-92	71288030392	25 VIAL, MULTI-DOSE in 1 CARTON (71288-303-92) / 1 mL in 1 VIAL, MULTI-DOSE (71288-303-91)		2020-09-24		No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cyanocobalamin Injection, USP	Meitheal Pharmaceuticals Inc. \| Gland Pharma Limited	2024-06-03	Human Prescription Drug Label	1
Cyanocobalamin Injection, USP	Meitheal Pharmaceuticals Inc. \| Gland Pharma Limited	2022-04-29	Human Prescription Drug Label	1