Prescription drug · ANDA
Calcium Acetate NDC 76282-377
Calcium acetate 667 mg/1 · Capsule · Oral · EXELAN PHARMACEUTICALS, INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76282-377-02 | 76282037702 | 200 CAPSULE in 1 BOTTLE (76282-377-02)Marketed from Apr 14, 2014 | |
| 76282-377-60 | 76282037760 | 60 CAPSULE in 1 BOTTLE (76282-377-60)Marketed from Apr 14, 2014 |
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)
- Calcium Acetate
- Generic name (nonproprietary)
- calcium acetate
- Active ingredients
- Calcium acetate — 667 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- EXELAN PHARMACEUTICALS, INC.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203135
- Marketing start
- Listing expires
- Other FDA classes
- Calcium (Chemical structure)Divalent (Chemical structure)Increased Coagulation Factor Activity (Physiologic effect)
- Identifiers
- Product ID 76282-377_b22d0aaf-0636-492b-981f-6c220640c1cdSPL ID b22d0aaf-0636-492b-981f-6c220640c1cdSPL set ID a5725f95-621e-425b-946d-434b3fec24ebRxCUI 359296UNII Y882YXF34X
- Pharmacologic class
- Blood Coagulation Factor
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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N476282037702followed by a unit qualifier and the quantityPackage 76282-0377-02. 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)
Calcium acetate is a phosphate binder indicated to reduce serum phosphorus in patients with end stage renal disease (ESRD). Calcium acetate is a phosphate binder indicated for the reduction of serum phosphorus in patients with end stage renal disease. ( 1 )
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 203135
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 |
|---|---|---|---|---|
| Calcium Acetate | Calcium acetate 667 mg/1 | CapsuleOral | American Health Packaging | 60687-589 |
| Calcium Acetate | Calcium acetate 667 mg/1 | CapsuleOral | Cipla USA Inc., | 69097-862 |