Vitamin Deficiency System

Product NDC: 70529-293
11-digit product format: 705290293
Labeler code: 70529
Product ID: 70529-293_9857ee19-c316-49d7-8a7a-ed78a40f4cd2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cyanocobalamin
Dosage form: INJECTION
Route: INTRAMUSCULAR; SUBCUTANEOUS
Labeler: IT3 Medical LLC
Application: ANDA080515
Marketing category: ANDA
Marketing start: 2017-03-01
Marketing end: 0000-00-00
Substance: CYANOCOBALAMIN
Active strength: 1000 ug/mL
Pharmacologic classes: Vitamin B 12 [CS], Vitamin B12 [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

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	70529-293		I	Inactivated by FDA		2026-08-03
excluded package	package	70529-293	70529-293-01	I	Inactivated by FDA		2026-08-03

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
A080515-002	CYANOCOBALAMIN	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	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
A080515-002	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	RLD / RS	Source SHA-256
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A080515-002	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A080515-002	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A080515-002	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A080515-002	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A080515-002	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A080515-002	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A080515-002	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A080515-002	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A080515-002	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A080515-002	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A080515-002	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A080515-002	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A080515-002	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A080515-002	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A080515-002	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A080515-002	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A080515-002	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A080515-002	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A080515-002	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A080515-002	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A080515-002	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A080515-002	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A080515-002	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A080515-002	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A080515-002	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A080515-002	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A080515-002	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A080515-002	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A080515-002	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`cb3db0bc1861…`
2026-08-01 22:54:32	2026-06	A080515-002	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A080515-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A080515-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A080515-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A080515-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A080515-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A080515-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A080515-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A080515-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A080515-002	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A080515-002	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A080515-002	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A080515-002	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A080515-002	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A080515-002	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A080515-002	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A080515-002	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A080515-002	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A080515-002	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A080515-002	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A080515-002	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A080515-002	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A080515-002	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A080515-002	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A080515-002	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A080515-002	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A080515-002	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A080515-002	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A080515-002	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A080515-002	AP	1	`cb3db0bc1861…`
2026-08-01 22:54:32	2026-06	A080515-002	AP	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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	HF Acquisition Co LLC, DBA HealthFirst	953aa8c6-31ce-0c3b-e053-2a95a90ab35f	2024-01-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080515 application number: ANDA080515
Cyanocobalamin	CYANOCOBALAMIN	Hikma Pharmaceuticals USA Inc.	a66eb3c4-3e1d-4d49-b963-4fa2334cc9b6	2023-12-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080515 application number: ANDA080515

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
70529-293-01	2023-07-28	C162847	48780-1	d6a99b39-ed18-a426-e053-dadaa90af4c2	Vitamin Deficiency System
70529-293-01	2022-03-01	C162847	48780-1	d6a99b39-ed18-a426-e053-dadaa90af4c2	Vitamin Deficiency System
70529-293-01	2022-01-28	C162847	48780-1	d6a99b39-ed18-a426-e053-dadaa90af4c2	Vitamin Deficiency System

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70529-293-01	Vitamin Deficiency System	1 in 1 PACKAGE	INJECTION	1		3
70529-293-01	Vitamin Deficiency System	30 mL in 1 VIAL, MULTI-DOSE	INJECTION	30		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70529-293	VITAMIN DEFICIENCY SYSTEM (CYANOCOBALAMIN) INJECTION [IT3 MEDICAL LLC]	3	Legacy NDC, 2 package rows	20220302_9172ca9d-6419-41de-829c-4f9a16220b46.zip

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	9172ca9d-6419-41de-829c-4f9a16220b46	3
309594	vitamin B12 1 MG/ML Injectable Solution	SCD	9172ca9d-6419-41de-829c-4f9a16220b46	3
309594	cyanocobalamin 1 MG/ML Injectable Solution	SY	9172ca9d-6419-41de-829c-4f9a16220b46	3
309594	cyanocobalamin 1000 MCG/ML Injectable Solution	SY	9172ca9d-6419-41de-829c-4f9a16220b46	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
70529-293-01	70529029301	1 VIAL, MULTI-DOSE in 1 PACKAGE (70529-293-01) > 30 mL in 1 VIAL, MULTI-DOSE	2017-03-01	0000-00-00	No	No	Current