🇺🇸
United States · US · US:63323-083_9def795c-abcf-483c-8b1d-e4374666efb2
Sodium Bicarbonate
In shortageOrange BookUNIISPLATC B05XA02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerFresenius Kabi USA, LLC
CountryUS (United States)
ATC codeB05XA02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11633230830525 VIAL, SINGLE-DOSE in 1 TRAY (63323-083-05) / 5 mL in 1 VIAL, SINGLE-DOSE (63323-083-03)
Annotations
UNII (FDA Substance ID)
8MDF5V39QO
SODIUM BICARBONATE
RxCUI 36676
Orange Book
A206688
APAP
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Sodium Acetate Injection
Raw payload (JSON)
{
"unii": {
"unii": "8MDF5V39QO",
"rxcui": "36676",
"inchikey": "UIIMBOGNXHQVGW-UHFFFAOYSA-M",
"display_name": "SODIUM BICARBONATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAVENOUS",
"spl_meta": {
"52430b12-4d5f-d1e1-e063-6394a90abd64": {
"match": "brand_token",
"title": "SODIUM FLUORIDE RINSE LIQUID [ROCKLAND COSMETICS, INC.]",
"spl_version": "1",
"published_date": "2026-05-21"
}
},
"productid": "63323-083_9def795c-abcf-483c-8b1d-e4374666efb2",
"productndc": "63323-083",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "206688",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "2.5MEQ/5ML (0.5MEQ/ML)",
"product_no": "001",
"approval_date": "Aug 25, 2025"
},
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "50MEQ/50ML (1MEQ/ML)",
"product_no": "002",
"approval_date": "Aug 25, 2025"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "SODIUM BICARBONATE",
"shortage_reason": "Sodium Acetate Injection",
"shortage_status": "current",
"proprietary_name": "Sodium Bicarbonate",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA206688",
"marketing_category": "ANDA",
"nonproprietary_name": "Sodium Bicarbonate",
"start_marketing_date": "20250825",
"active_numerator_strength": "42"
}Related drugs
Other records sharing ATC code B05XA02.
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- IE8.4% w/v Sodium Bicarbonate Intravenous Infusion BPB. Braun Medical Limited
- GBAactiWax Sodium Bicarbonate 5% ear dropsTriOn Pharma Ltd
- GBAciBic 500mg capsulesMaN Pharma Ltd
- GBAciBic 600mg tabletsMaN Pharma Ltd
- 🇺🇸ADRIAN BICARBONATOEvi Labs
- 🇺🇸After Bite AdvancedTender Corporation d/b/a Adventure Ready Brands
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