Prescription drug · ANDA
Calcium Acetate NDC 76483-086
Calcium acetate 667 mg/1 · Capsule · Oral · SQUARE PHARMACEUTICALS LIMITED
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76483-086-00 | 7648300860076483008600 | 200 CAPSULE in 1 BOTTLE (76483-086-00)Marketed from May 31, 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)
- Calcium Acetate
- Generic name (nonproprietary)
- calcium acetate
- Active ingredients
- Calcium acetate — 667 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- SQUARE PHARMACEUTICALS LIMITEDNDC labeler code 76483
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 217205
- Marketing start
- Listing expires
- Other FDA classes
- Calcium (Chemical structure)Divalent (Chemical structure)Increased Coagulation Factor Activity (Physiologic effect)Phosphate Chelating Activity (Mechanism)
- Identifiers
- Product ID 76483-086_6561c80c-48b4-4318-a28c-7cca27cd2885SPL ID 6561c80c-48b4-4318-a28c-7cca27cd2885SPL set ID 5af79d16-31ad-4d68-9a6d-bb5d9c91535dRxCUI 359296UNII Y882YXF34X
- Pharmacologic class
- Blood Coagulation Factor; Phosphate Binder
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
N476483008600followed by a unit qualifier and the quantityPackage 76483-0086-00. 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 capsules are a phosphate binder indicated to reduce serum phosphorus in patients with end stage renal disease (ESRD). Calcium acetate capsules are 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.
About NDC 76483-086
- What is NDC 76483-086?
- 76483-086 is the product NDC for Calcium Acetate, Calcium acetate 667 mg/1 capsule, listed with the FDA by SQUARE PHARMACEUTICALS LIMITED. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Calcium Acetate.
- What is the active ingredient?
- Calcium acetate.
- Who is the labeler?
- SQUARE PHARMACEUTICALS LIMITED, NDC labeler code 76483. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Calcium Acetate?
- 21 other product NDCs are listed under this name. See all Calcium Acetate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Calcium Acetate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Calcium Acetate | Calcium acetate 667 mg/1 | CapsuleOral | American Health Packaging | 60687-589 | 60687-0589-65 |
| Calcium Acetate | Calcium acetate 667 mg/1 | CapsuleOral | AvPAK | 50268-203 | 50268-0203-15 |
| Calcium Acetate | Calcium acetate 667 mg/1 | CapsuleOral | Westminster Pharmaceuticals, LLC | 69367-411 | 69367-0411-02 |
| Calcium Acetate | Calcium acetate 667 mg/1 | CapsuleOral | Proficient Rx LP | 82804-968 | 82804-0968-0082804-0968-2082804-0968-30+6 more |
| calcium acetate | Calcium acetate 667 mg/1 | CapsuleOral | AvKARE | 73190-031 | 73190-0031-20 |
| calcium acetate | Calcium acetate 667 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4299 | 70518-4299-00 |
| Calcium Acetate | Calcium acetate 667 mg/1 | CapsuleOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8632 | 00615-8632-39 |
| Calcium Acetate | Calcium acetate 667 mg/1 | CapsuleOral | PD-Rx Pharmaceuticals, Inc. | 72789-422 | 72789-0422-97 |
| Calcium Acetate | Calcium acetate 667 mg/1 | CapsuleOral | Nivagen Pharmaceuticals, Inc. | 75834-323 | 75834-0323-02 |
| Calcium Acetate | Calcium acetate 667 mg/1 | CapsuleOral | Rising Pharma Holdings, Inc. | 16571-813 | 16571-0813-20 |
Other NDCs under ANDA 217205
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 | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8632 |
| Calcium Acetate | Calcium acetate 667 mg/1 | CapsuleOral | PD-Rx Pharmaceuticals, Inc. | 72789-422 |
| Calcium Acetate | Calcium acetate 667 mg/1 | CapsuleOral | Nivagen Pharmaceuticals, Inc. | 75834-323 |