Sodium Acetate
- Product NDC
- 0641-6261
- 11-digit product format
- 006416261
- Labeler code
- 0641
- Product ID
- 0641-6261_3493d4c1-4f73-44e8-94bc-7b55fe4fd436
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sodium Acetate
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- ANDA216920
- Marketing category
- ANDA
- Marketing start
- 2024-05-20
- Substance
- SODIUM ACETATE ANHYDROUS
- Active strength
- 164 mg/mL
- Pharmacologic classes
- Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Sodium Acetate
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| SODIUM ACETATE ANHYDROUS | 164 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | NVG71ZZ7P0 |
| Rxcui | 1859490 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0641-6261-01 | Sodium Acetate | 20 mL in 1 VIAL | INJECTION | 20 | | 1 |
| 0641-6261-01 | Sodium Acetate | 1 in 1 CARTON | INJECTION | 1 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0641-6261 | SODIUM ACETATE INJECTION [HIKMA PHARMACEUTICALS USA INC.] | 1 | Current NDC, 2 package rows | 20240520_8a338072-6f1e-460c-b9ec-59cef4f3f597.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 0641-6261-01 | 00641626101 | 1 VIAL in 1 CARTON (0641-6261-01) / 20 mL in 1 VIAL | 1 vial | 2024-05-20 | No | No | Current |