Hydroxocobalamin

Product NDC: 0591-2888
11-digit product format: 005912888
Labeler code: 0591
Product ID: 0591-2888_c47477bf-6413-4699-ab77-c5441a9d1557
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Hydroxocobalamin
Dosage form: INJECTION, SOLUTION
Route: INTRAMUSCULAR
Labeler: Actavis Pharma, Inc.
Application: ANDA085998
Marketing category: ANDA
Marketing start: 2010-11-12
Substance: HYDROXOCOBALAMIN ACETATE
Active strength: 1000 ug/mL
Pharmacologic classes: Antidote [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
A085998-001	HYDROXOCOBALAMIN	HYDROXOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION		RS, Approved before 1982

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A085998-001	HYDROXOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A085998-001	HYDROXOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A085998-001	HYDROXOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A085998-001	HYDROXOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A085998-001	HYDROXOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A085998-001	HYDROXOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A085998-001	HYDROXOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A085998-001	HYDROXOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A085998-001	HYDROXOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A085998-001	HYDROXOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A085998-001	HYDROXOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A085998-001	HYDROXOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A085998-001	HYDROXOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A085998-001	HYDROXOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A085998-001	HYDROXOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A085998-001	HYDROXOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A085998-001	HYDROXOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A085998-001	HYDROXOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A085998-001	HYDROXOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A085998-001	HYDROXOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A085998-001	HYDROXOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A085998-001	HYDROXOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A085998-001	HYDROXOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A085998-001	HYDROXOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A085998-001	HYDROXOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A085998-001	HYDROXOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A085998-001	HYDROXOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A085998-001	HYDROXOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A085998-001	HYDROXOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	RS, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A085998-001	HYDROXOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A085998-001	HYDROXOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A085998-001	HYDROXOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A085998-001	HYDROXOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A085998-001	HYDROXOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A085998-001	HYDROXOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A085998-001	HYDROXOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A085998-001	HYDROXOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	RS, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A085998-001	HYDROXOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	RS, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A085998-001	HYDROXOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	RS, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A085998-001	HYDROXOCOBALAMIN	1MG/ML	INJECTABLE / INJECTION	RS, Approved before 1982	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Hydroxocobalamin
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
HYDROXOCOBALAMIN ACETATE	1000 ug/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
S535M27N3Q	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
317106	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
a3087a39-f218-4f16-a1e7-17c39bb2eb69	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
a21a21e5-f36d-4c1f-8918-def921b8f7e3	Product name	3	20250124
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
48747306-602a-42cc-957b-5b0c69158eee	Product name	1	20180604
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
b060cc1a-fe47-856b-0b77-4448b5963de8	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578b	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0591-2888-30	2024-02-06	C162847	48780-1	1030e365-69d9-111a-e063-dadaa90a10e2	HYDROXOCOBALAMIN INJECTION USP Rx Only
0591-2888-30	2024-01-30	C162847	48780-1	1030e365-69d9-111a-e063-dadaa90a10e2	HYDROXOCOBALAMIN INJECTION USP Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0591-2888-30	Hydroxocobalamin	30 mL in 1 VIAL, MULTI-DOSE	INJECTION, SOLUTION	30		5
0591-2888-30	Hydroxocobalamin	1 in 1 CARTON	INJECTION, SOLUTION	1		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0591-2888-30	ML - Milliliter	0591-2888	2af49d19-5770-4b47-9a4a-0ae096e3fd5d	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
HYDROXOCOBALAMIN ACETATE	ACTIVE INGREDIENT	S535M27N3Q	HYDROXOCOBALAMIN INJECTION, SOLUTION [WATSON LABORATORIES, INC.]	2
HYDROXOCOBALAMIN	ACTIVE MOIETY	Q40X8H422O	HYDROXOCOBALAMIN INJECTION, SOLUTION [WATSON LABORATORIES, INC.]	2
ACETIC ACID	INACTIVE INGREDIENT	Q40Q9N063P	HYDROXOCOBALAMIN INJECTION, SOLUTION [WATSON LABORATORIES, INC.]	2
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	HYDROXOCOBALAMIN INJECTION, SOLUTION [WATSON LABORATORIES, INC.]	2
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	HYDROXOCOBALAMIN INJECTION, SOLUTION [WATSON LABORATORIES, INC.]	2
SODIUM ACETATE ANHYDROUS	INACTIVE INGREDIENT	NVG71ZZ7P0	HYDROXOCOBALAMIN INJECTION, SOLUTION [WATSON LABORATORIES, INC.]	2
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	HYDROXOCOBALAMIN INJECTION, SOLUTION [WATSON LABORATORIES, INC.]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	HYDROXOCOBALAMIN INJECTION, SOLUTION [WATSON LABORATORIES, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0591-2888	HYDROXOCOBALAMIN INJECTION, SOLUTION [ACTAVIS PHARMA, INC.]	5	Current NDC, Legacy NDC, 2 package rows	20240207_a3087a39-f218-4f16-a1e7-17c39bb2eb69.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydroxocobalamin	HYDROXOCOBALAMIN	Actavis Pharma, Inc.	a3087a39-f218-4f16-a1e7-17c39bb2eb69	2017-01-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 085998 application number: ANDA085998 ndc (product): 0591-2888

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
S535M27N3Q	HYDROXOCOBALAMIN ACETATE	22465-48-1	HYDROXOCOBALAMIN ACETATE
Q40X8H422O	HYDROXOCOBALAMIN	13422-51-0	Hydroxocobalamin

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
317106	hydroxocobalamin 1000 MCG/ML Injectable Solution	PSN	a3087a39-f218-4f16-a1e7-17c39bb2eb69	5
317106	hydroxocobalamin 1 MG/ML Injectable Solution	SCD	a3087a39-f218-4f16-a1e7-17c39bb2eb69	5
317106	hydroxocobalamin (as hydroxocobalamin acetate) 1000 MCG/ML Injectable Solution	SY	a3087a39-f218-4f16-a1e7-17c39bb2eb69	5
317106	hydroxocobalamin 1000 MCG/ML Injectable Solution	SY	a3087a39-f218-4f16-a1e7-17c39bb2eb69	5
317106	hydroxocobalamin 1000 MCG/ML Injectable Solution	PSN	17e7d7d8-d27c-4888-84b9-45305df62066	4
317106	hydroxocobalamin 1 MG/ML Injectable Solution	SCD	17e7d7d8-d27c-4888-84b9-45305df62066	4
317106	hydroxocobalamin (as hydroxocobalamin acetate) 1000 MCG/ML Injectable Solution	SY	17e7d7d8-d27c-4888-84b9-45305df62066	4
317106	hydroxocobalamin 1000 MCG/ML Injectable Solution	SY	17e7d7d8-d27c-4888-84b9-45305df62066	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0591-2888-30	00591288830	1 VIAL, MULTI-DOSE in 1 CARTON (0591-2888-30) / 30 mL in 1 VIAL, MULTI-DOSE	2010-11-12	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
HYDROXOCOBALAMIN INJECTION USP Rx Only	A-S Medication Solutions	2020-01-18	HUMAN PRESCRIPTION DRUG LABEL	4
HYDROXOCOBALAMIN INJECTION USP Rx Only	Actavis Pharma, Inc.	2017-01-31	HUMAN PRESCRIPTION DRUG LABEL	5