Prescription drug · ANDA
Zinc Sulfate NDC 66794-239
Zinc sulfate 25 mg/5mL · Injection, Solution · Intravenous · Piramal Critical Care Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 66794-239-42 | 6679402394266794023942 | 25 VIAL in 1 CARTON (66794-239-42) / 5 mL in 1 VIAL (66794-239-02)Marketed from Jun 20, 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)
- Zinc Sulfate
- Generic name (nonproprietary)
- zinc sulfate
- Active ingredients
- Zinc sulfate — 25 mg/5mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Piramal Critical Care Inc.NDC labeler code 66794
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216249
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Copper Ion Absorption (Physiologic effect)
- Identifiers
- Product ID 66794-239_408d57c6-f539-d129-e063-6394a90a226bSPL ID 408d57c6-f539-d129-e063-6394a90a226bSPL set ID dfa8a859-c285-17a3-e053-2a95a90a9343RxCUI 2201521, 2201524UNII 89DS0H96TB
- Pharmacologic class
- Copper Absorption Inhibitor
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
N466794023942followed by a unit qualifier and the quantityPackage 66794-0239-42. 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)
Zinc Sulfate Injection is indicated in adult and pediatric patients as a source of zinc for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. Zinc Sulfate Injection is a trace element indicated in adult and pediatric patients as a source of zinc for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 66794-239
- What is NDC 66794-239?
- 66794-239 is the product NDC for Zinc Sulfate, Zinc sulfate 25 mg/5mL injection, solution, listed with the FDA by Piramal Critical Care Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Zinc Sulfate.
- What is the active ingredient?
- Zinc sulfate.
- Who is the labeler?
- Piramal Critical Care Inc., NDC labeler code 66794. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Zinc Sulfate?
- 24 other product NDCs are listed under this name. See all Zinc Sulfate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Zinc Sulfate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Zinc Sulfate | Zinc sulfate 1 mg/mL | Injection, SolutionIntravenous | Camber Pharmaceuticals, Inc. | 31722-453 | 31722-0453-31 |
| Zinc Sulfate | Zinc sulfate 3 mg/mL | Injection, SolutionIntravenous | Camber Pharmaceuticals, Inc. | 31722-454 | 31722-0454-31 |
| Zinc Sulfate | Zinc sulfate 5 mg/mL | Injection, SolutionIntravenous | Camber Pharmaceuticals, Inc. | 31722-455 | 31722-0455-31 |
| Zinc Sulfatezinc sulfate injection | Zinc sulfate, Unspecified form 1 mg/mL | InjectionIntravenous | Apotex Corp | 60505-6261 | 60505-6261-05 |
| Zinc Sulfatezinc sulfate injection | Zinc sulfate, Unspecified form 5 mg/mL | InjectionIntravenous | Apotex Corp | 60505-6260 | 60505-6260-05 |
| Zinc sulfate | Zinc sulfate 5 mg/mL | SolutionIntravenous | Somerset Therapeutics, LLC | 70069-691 | 70069-0691-25 |
| Zinc sulfate | Zinc sulfate 3 mg/mL | SolutionIntravenous | Somerset Therapeutics, LLC | 70069-692 | 70069-0692-25 |
| zinc sulfatezinc sulfate injection, | Zinc sulfate 1 mg/mL | SolutionIntravenous | Zydus Pharmaceuticals USA Inc. | 70710-1876 | 70710-1876-07 |
| zinc sulfatezinc sulfate injection, | Zinc sulfate 3 mg/mL | SolutionIntravenous | Zydus Pharmaceuticals USA Inc. | 70710-1877 | 70710-1877-07 |
| zinc sulfatezinc sulfate injection, | Zinc sulfate 5 mg/mL | SolutionIntravenous | Zydus Pharmaceuticals USA Inc. | 70710-1878 | 70710-1878-07 |
Other NDCs under ANDA 216249
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 |
|---|---|---|---|---|
| Zinc Sulfate | Zinc sulfate 30 mg/10mL | Injection, SolutionIntravenous | Piramal Critical Care Inc. | 66794-240 |
| Zinc Sulfate | Zinc sulfate 1 mg/mL | Injection, SolutionIntravenous | Piramal Critical Care Inc. | 66794-255 |
| Zinc Sulfate | Zinc sulfate 3 mg/mL | Injection, SolutionIntravenous | Gland Pharma Limited | 68083-498 |
| Zinc Sulfate | Zinc sulfate 5 mg/mL | Injection, SolutionIntravenous | Gland Pharma Limited | 68083-499 |
| Zinc Sulfate | Zinc sulfate 1 mg/mL | Injection, SolutionIntravenous | Gland Pharma Limited | 68083-608 |