Prescription drug · ANDA
Zinc Sulfate NDC 68083-608
Zinc sulfate 1 mg/mL · Injection, Solution · Intravenous · Gland Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68083-608-25 | 68083060825 | 25 VIAL in 1 CARTON (68083-608-25) / 10 mL in 1 VIALMarketed from Sep 1, 2023 |
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 — 1 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Gland Pharma LimitedNDC labeler code 68083
- 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 68083-608_cfa59996-1de2-4313-a7ac-1766764513e2SPL ID cfa59996-1de2-4313-a7ac-1766764513e2SPL set ID 8f354f0a-4e10-4e4e-b86c-49d97cbd631dRxCUI 2201521, 2201524, 2369390UNII 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
N468083060825followed by a unit qualifier and the quantityPackage 68083-0608-25. 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.
Excerpt only. Read the full label for complete information.
About NDC 68083-608
- What is NDC 68083-608?
- 68083-608 is the product NDC for Zinc Sulfate, Zinc sulfate 1 mg/mL injection, solution, listed with the FDA by Gland Pharma Limited. 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?
- Gland Pharma Limited, NDC labeler code 68083. 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 sulfate | Zinc sulfate 5 mg/mL | Injection, SolutionIntravenous | Zydus Lifesciences Limited | 70771-1850 | 70771-1850-07 |
| zinc sulfate | Zinc sulfate 1 mg/mL | Injection, SolutionIntravenous | Zydus Lifesciences Limited | 70771-1848 | 70771-1848-07 |
| zinc sulfate | Zinc sulfate 3 mg/mL | Injection, SolutionIntravenous | Zydus Lifesciences Limited | 70771-1849 | 70771-1849-07 |
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 25 mg/5mL | Injection, SolutionIntravenous | Piramal Critical Care Inc. | 66794-239 |
| 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 |