Hydroxocobalamin
openFDA label record#
This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.
Verified complete openFDA source JSON
- Brand name
- Hydroxocobalamin
- Generic name
- HYDROXOCOBALAMIN
- Manufacturer
- Actavis Pharma, Inc.
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- a3087a39-f218-4f16-a1e7-17c39bb2eb69
- SPL ID
- c47477bf-6413-4699-ab77-c5441a9d1557
- Version
- 5
- Effective date
- 2017-01-31
- Source export date
- 2026-10-12
- Source partition
- 5
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0005-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-10-12/13cbfcd236c665f0ee69e2d9141331148dcdff45d1679c92f029cfba27dd74a2/drug-label-0005-of-0014.json.zip
- Source manifest SHA-256
- 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
- Import run
- 20261013T011858Z
- Imported at
- 2026-10-13 01:40:48
| Harmonized routes |
|---|
| INTRAMUSCULAR |
Harmonized identifier links#
Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| application applno | ANDA | 085998 | derived:openfda.application_number |
| application number | ANDA085998 | openfda.application_number | |
| brand name | Hydroxocobalamin | openfda.brand_name | |
| generic name | HYDROXOCOBALAMIN | openfda.generic_name | |
| manufacturer name | Actavis Pharma, Inc. | openfda.manufacturer_name | |
| ndc | package | 0591-2888-30 | openfda.package_ndc |
| ndc | product | 0591-2888 | openfda.product_ndc |
| ndc11 | package | 00591288830 | derived:openfda.package_ndc |
| rxcui | 317106 | openfda.rxcui | |
| spl id | c47477bf-6413-4699-ab77-c5441a9d1557 | id | |
| spl set id | a3087a39-f218-4f16-a1e7-17c39bb2eb69 | set_id | |
| unii | S535M27N3Q | openfda.unii |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
WARNINGS Avoid the intravenous route. Folic acid is not a substitute for vitamin B 12 although it may improve vitamin B 12 deficient megaloblastic anemia. Exclusive use of folic acid in treating vitamin B 12 deficient megaloblastic anemia could result in progressive and irreversible neurologic damage. Blunted or impeded therapeutic response to vitamin B 12 may be due to such conditions as infection, uremia, drugs having bone marrow suppressant properties such as chloramphenicol, and concurrent iron or folic acid deficiency.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS Mild transient diarrhea, itching, transitory exanthema, feeling of swelling of entire body, and anaphylaxis. A few patients may experience pain after injection of hydroxocobalamin. To report SUSPECTED ADVERSE EVENTS, contact Actavis at 1-800-272-5525 or FDA at 1-800-FDA-1088 or http://www.fda.gov/ for voluntary reporting of adverse reactions.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.