🇺🇸
United States · US · US:0591-2888_c47477bf-6413-4699-ab77-c5441a9d1557
Hydroxocobalamin
In shortageOrange BookUNIISPLATC B03BA03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerActavis Pharma, Inc.
CountryUS (United States)
ATC codeB03BA03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1105912888301 VIAL, MULTI-DOSE in 1 CARTON (0591-2888-30) / 30 mL in 1 VIAL, MULTI-DOSE
Annotations
UNII (FDA Substance ID)
S535M27N3Q
HYDROXOCOBALAMIN ACETATE
RxCUI 236302
Orange Book
A085998
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Hydroxocobalamin Injection
Raw payload (JSON)
{
"unii": {
"unii": "S535M27N3Q",
"rxcui": "236302",
"inchikey": "KPFAAKYTRSSOQN-UVKKECPRSA-K",
"display_name": "HYDROXOCOBALAMIN ACETATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAMUSCULAR",
"spl_meta": {
"3be23e83-4a7f-3854-e063-6294a90acb7a": {
"match": "brand_token",
"title": "HYDROXOCOBALAMIN INJECTION [XSEER PHARMACEUTICALS]",
"spl_version": "2",
"published_date": "2026-06-02"
}
},
"productid": "0591-2888_c47477bf-6413-4699-ab77-c5441a9d1557",
"productndc": "0591-2888",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "085998",
"products": [
{
"rs": true,
"rld": false,
"te_code": null,
"strength": "1MG/ML",
"product_no": "001",
"approval_date": "Approved Prior to Jan 1, 1982"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "HYDROXOCOBALAMIN ACETATE",
"shortage_reason": "Hydroxocobalamin Injection",
"shortage_status": "current",
"proprietary_name": "Hydroxocobalamin",
"active_ingred_unit": "ug/mL",
"application_number": "ANDA085998",
"marketing_category": "ANDA",
"nonproprietary_name": "Hydroxocobalamin",
"start_marketing_date": "20101112",
"active_numerator_strength": "1000"
}Related drugs
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