Prescription drug · ANDA
Sodium Phosphates NDC 63323-884
Sodium phosphate, Monobasic, Monohydrate 276 mg/mL; Sodium phosphate, Dibasic, Anhydrous 142 mg/mL · Injection, Solution · Intravenous · Fresenius Kabi USA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63323-884-06 | 63323088406 | 25 VIAL, SINGLE-DOSE in 1 TRAY (63323-884-06) / 5 mL in 1 VIAL, SINGLE-DOSE (63323-884-01)Marketed from Mar 30, 2022 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Sodium Phosphates
- Generic name (nonproprietary)
- sodium phosphate, monobasic, monohydrate and sodium phosphate, dibasic, anhydrous
- Active ingredients
- Sodium phosphate, Monobasic, Monohydrate — 276 mg/mLSodium phosphate, Dibasic, Anhydrous — 142 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Fresenius Kabi USA, LLCNDC labeler code 63323
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209997
- Marketing start
- Listing expires
- Other FDA classes
- Increased Large Intestinal Motility (Physiologic effect)Inhibition Large Intestine Fluid/Electrolyte Absorption (Physiologic effect)Osmotic Activity (Mechanism)
- Identifiers
- Product ID 63323-884_3ae3c9a3-3503-4264-8c77-00089f50cc74SPL ID 3ae3c9a3-3503-4264-8c77-00089f50cc74SPL set ID 5bf47be3-f3fe-452b-8113-941796498345RxCUI 1872384, 1872443, 1872447UNII 22ADO53M6F, 593YOG76RN
- Pharmacologic class
- Osmotic Laxative
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N463323088406followed by a unit qualifier and the quantityPackage 63323-0884-06. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
INDICATIONS AND USAGE: Sodium Phosphates Injection, USP, 3 mM P/mL is indicated as a source of phosphorus, for addition to large volume intravenous fluids, to prevent or correct hypophosphatemia in patients with restricted or no oral intake. It is also useful as an additive for preparing specific parenteral fluid formulas when the needs of the patient cannot be met by standard electrolyte or nutrient solutions. The concomitant amount of sodium (Na + 4 mEq/mL) must be calculated into total electrolyte dose of such prepared solutions.
Excerpt only. Read the full label for complete information.
About NDC 63323-884
- What is NDC 63323-884?
- 63323-884 is the product NDC for Sodium Phosphates, Sodium phosphate, Monobasic, Monohydrate 276 mg/mL; Sodium phosphate, Dibasic, Anhydrous 142 mg/mL injection, solution, listed with the FDA by Fresenius Kabi USA, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Sodium Phosphates (Sodium phosphate, monobasic, monohydrate and sodium phosphate, dibasic, anhydrous).
- What is the active ingredient?
- Sodium phosphate, Monobasic, Monohydrate, Sodium phosphate, Dibasic, Anhydrous.
- Who is the labeler?
- Fresenius Kabi USA, LLC, NDC labeler code 63323. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Sodium Phosphates?
- 14 other product NDCs are listed under this name. See all Sodium Phosphates NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Sodium Phosphates products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Sodium Phosphates | Sodium phosphate, Monobasic, Monohydrate 276 mg/mL; Sodium phosphate, Dibasic, Heptahydrate 268 mg/mL | Injection, SolutionIntravenous | Caplin Steriles Limited | 65145-200 | 65145-0200-25 |
| Sodium Phosphates | Sodium phosphate, Monobasic, Monohydrate 276 mg/mL; Sodium phosphate, Dibasic, Heptahydrate 268 mg/mL | Injection, SolutionIntravenous | Caplin Steriles Limited | 65145-201 | 65145-0201-25 |
| Sodium Phosphates | Sodium phosphate, Monobasic, Monohydrate 276 mg/mL; Sodium phosphate, Dibasic, Heptahydrate 268 mg/mL | Injection, SolutionIntravenous | Caplin Steriles Limited | 65145-202 | 65145-0202-25 |
| Sodium Phosphates | Sodium phosphate, Monobasic, Monohydrate 276 mg/mL; Sodium phosphate, Dibasic, Heptahydrate 268 mg/mL | Injection, SolutionIntravenous | GLENMARK PHARMACEUTICALS INC., USA | 68462-728 | 68462-0728-25 |
| Sodium Phosphates | Sodium phosphate, Monobasic, Monohydrate 276 mg/mL; Sodium phosphate, Dibasic, Heptahydrate 268 mg/mL | Injection, SolutionIntravenous | GLENMARK PHARMACEUTICALS INC., USA | 68462-729 | 68462-0729-25 |
| Sodium Phosphates | Sodium phosphate, Monobasic, Monohydrate 276 mg/mL; Sodium phosphate, Dibasic, Heptahydrate 268 mg/mL | Injection, SolutionIntravenous | GLENMARK PHARMACEUTICALS INC., USA | 68462-730 | 68462-0730-25 |
| Sodium Phosphatessodium phosphate, monobasic, monohydrate and sodium phosphate, dibasic anhydrous | Sodium phosphate, Monobasic, Monohydrate 276 mg/mL; Sodium phosphate, Dibasic, Anhydrous 142 mg/mL | Injection, SolutionIntravenous | Civica, Inc. | 72572-309 | 72572-0309-25 |
| Sodium Phosphatessodium phosphate, monobasic, monohydrate and sodium phosphate, dibasic anhydrous | Sodium phosphate, Monobasic, Monohydrate 276 mg/mL; Sodium phosphate, Dibasic, Anhydrous 142 mg/mL | Injection, SolutionIntravenous | American Regent, Inc. | 0517-7350 | 00517-7350-25 |
| Sodium Phosphatessodium phosphate, monobasic, monohydrate and sodium phosphate, dibasic anhydrous | Sodium phosphate, Monobasic, Monohydrate 276 mg/mL; Sodium phosphate, Dibasic, Anhydrous 142 mg/mL | Injection, SolutionIntravenous | American Regent, Inc. | 0517-7305 | 00517-7305-25 |
| Sodium Phosphatessodium phosphate, monobasic, monohydrate and sodium phosphate, dibasic anhydrous | Sodium phosphate, Monobasic, Monohydrate 276 mg/mL; Sodium phosphate, Dibasic, Anhydrous 142 mg/mL | Injection, SolutionIntravenous | American Regent, Inc. | 0517-7315 | 00517-7315-25 |
Other NDCs under ANDA 209997
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Sodium Phosphatessodium phosphate, monobasic, monohydrate and sodium phosphate, dibasic, anhydrous | Sodium phosphate, Monobasic, Monohydrate 276 mg/mL; Sodium phosphate, Dibasic, Anhydrous 142 mg/mL | Injection, SolutionIntravenous | Fresenius Kabi USA, LLC | 63323-881 |
| Sodium Phosphatessodium phosphate, monobasic, monohydrate and sodium phosphate, dibasic, anhydrous | Sodium phosphate, Monobasic, Monohydrate 276 mg/mL; Sodium phosphate, Dibasic, Anhydrous 142 mg/mL | Injection, SolutionIntravenous | Fresenius Kabi USA, LLC | 63323-886 |