Sodium Bicarbonate
- Product NDC
- 63323-089
- 11-digit product format
- 633230089
- Labeler code
- 63323
- Product ID
- 63323-089_9def795c-abcf-483c-8b1d-e4374666efb2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sodium Bicarbonate
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Fresenius Kabi USA, LLC
- Application
- ANDA206688
- Marketing category
- ANDA
- Marketing start
- 2025-08-25
- Substance
- SODIUM BICARBONATE
- Active strength
- 84 mg/mL
- Pharmacologic classes
- Alkalinizing Activity [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Sodium Bicarbonate
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| SODIUM BICARBONATE | 84 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 8MDF5V39QO |
| Rxcui | 1868469, 1868486 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63323-089-25 | Sodium Bicarbonate | 50 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 50 | | 8 |
| 63323-089-50 | Sodium Bicarbonate | 25 in 1 TRAY | INJECTION, SOLUTION | 25 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63323-089 | SODIUM BICARBONATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 7 | Current NDC, Legacy NDC, 2 package rows | 20250322_0ab55004-bb63-436d-ad77-cd3796905370.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 63323-089-25 | 63323008925 | 50 mL in 1 VIAL, SINGLE-DOSE | 50 ml | | | | | Historical |
| 63323-089-50 | 63323008950 | 25 VIAL, SINGLE-DOSE in 1 TRAY (63323-089-50) / 50 mL in 1 VIAL, SINGLE-DOSE (63323-089-25) | | 2025-08-25 | 0000-00-00 | No | No | Current |