Vitamin Deficiency Injectable System - B12

Product NDC: 70529-290
Requested package NDC: 70529-290-01
11-digit product format: 705290290
Labeler code: 70529
Product ID: 70529-290_b2695b74-358c-4cc6-92a5-a18d9b350b90
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cyanocobalamin
Dosage form: KIT
Labeler: IT3 Medical LLC
Application: ANDA080515
Marketing category: ANDA
Marketing start: 2016-05-01
Marketing end: 0000-00-00
Active strength: 0
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	70529-290	70529-290-01	I	Inactivated by FDA		2026-09-14

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 15 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

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
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.

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	RLD / RS	Source SHA-256
2026-09-14 22:38:34	2026-08	A080515-002	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A080515-002	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A080515-002	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A080515-002	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A080515-002	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A080515-002	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A080515-002	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A080515-002	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A080515-002	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A080515-002	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A080515-002	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A080515-002	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A080515-002	CYANOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`79d66fd596c7…`
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…`

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	A080515-002	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A080515-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A080515-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A080515-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A080515-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A080515-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A080515-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A080515-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A080515-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A080515-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A080515-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A080515-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A080515-002	AP	1	`79d66fd596c7…`
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…`

Reported adverse events (FAERS/openFDA)#

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

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
70529-290-01	2023-07-28	C162847	48780-1	d6a99b39-51b0-a426-e053-dadaa90af4c2	Vitamin Deficiency Injectable System - B12
70529-290-01	2022-03-01	C162847	48780-1	d6a99b39-51b0-a426-e053-dadaa90af4c2	Vitamin Deficiency Injectable System - B12
70529-290-01	2022-01-28	C162847	48780-1	d6a99b39-51b0-a426-e053-dadaa90af4c2	Vitamin Deficiency Injectable System - B12

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0143-9621-01	Vitamin Deficiency Injectable System - B12	1 mL in 1 VIAL	INJECTION	1 mL	1000 ug in 1mL	4
68599-5804-1	Vitamin Deficiency Injectable System - B12	1 mL in 1 PACKET	SWAB	2 mL	0.7 mL in 1mL	4
70529-290-01	Vitamin Deficiency Injectable System - B12	1 in 1 PACKAGE	KIT	1		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70529-290-01	EA - Each	70529-290	53cf9737-8bca-40ac-a5eb-6e957e514e89	1	2017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70529-290	VITAMIN DEFICIENCY INJECTABLE SYSTEM - B12 (CYANOCOBALAMIN) KIT [IT3 MEDICAL LLC]	4	Legacy NDC, 3 package rows	20220302_579bd1fe-51a1-403f-a422-0fb701aab57d.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	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

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	579bd1fe-51a1-403f-a422-0fb701aab57d	4
797544	isopropyl alcohol 70 % Medicated Pad	PSN	579bd1fe-51a1-403f-a422-0fb701aab57d	4
797544	isopropyl alcohol 0.7 ML/ML Medicated Pad	SCD	579bd1fe-51a1-403f-a422-0fb701aab57d	4
309594	vitamin B12 1 MG/ML Injectable Solution	SCD	579bd1fe-51a1-403f-a422-0fb701aab57d	4
309594	cyanocobalamin 1 MG/ML Injectable Solution	SY	579bd1fe-51a1-403f-a422-0fb701aab57d	4
309594	cyanocobalamin 1000 MCG/ML Injectable Solution	SY	579bd1fe-51a1-403f-a422-0fb701aab57d	4
797544	isopropyl alcohol 70 % Medicated Pad	SY	579bd1fe-51a1-403f-a422-0fb701aab57d	4
797544	isopropyl alcohol 70 % Topical Cloth	SY	579bd1fe-51a1-403f-a422-0fb701aab57d	4
797544	isopropyl alcohol 70 % Topical Swab	SY	579bd1fe-51a1-403f-a422-0fb701aab57d	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70529-290-01	70529029001	1 KIT in 1 PACKAGE (70529-290-01) * 1 mL in 1 VIAL (0143-9621-01) * 1 mL in 1 PACKET (68599-5804-1)	1 kit	2016-05-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Vitamin Deficiency Injectable System - B12	IT3 Medical LLC	2022-02-25	HUMAN PRESCRIPTION DRUG LABEL	4