Prescription drug · ANDA
Lanthanum carbonate NDC 69097-934
Lanthanum carbonate 500 mg/1 · Tablet, Chewable · Oral · Cipla USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69097-934-98 | 6909709349869097093498 | 2 BOTTLE in 1 PACKAGE (69097-934-98) / 45 TABLET, CHEWABLE in 1 BOTTLE (69097-934-57)Marketed from Jan 25, 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)
- Lanthanum carbonate
- Generic name (nonproprietary)
- lanthanum carbonate
- Active ingredients
- Lanthanum carbonate — 500 mg/1
- Dosage form
- Tablet, Chewable
- Route
- Oral
- Labeler
- Cipla USA Inc.NDC labeler code 69097
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206868
- Marketing start
- Listing expires
- Other FDA classes
- Phosphate Chelating Activity (Mechanism)
- Identifiers
- Product ID 69097-934_df0330c5-d556-4698-accd-70a9c948687dSPL ID df0330c5-d556-4698-accd-70a9c948687dSPL set ID 1d5ff930-1189-4e96-bdfb-9fd9c2c83d1bRxCUI 477347, 602635, 642452UNII 490D9F069TUPC 0369097935894, 0369097936655, 0369097934576
- Pharmacologic class
- 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
N469097093498followed by a unit qualifier and the quantityPackage 69097-0934-98. 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)
Lanthanum carbonate chewable tablets are phosphate binder indicated to reduce serum phosphate in patients with end- stage renal disease (ESRD). Management of elevated serum phosphorus levels in patients with ESRD usually includes all of the following: reduction in dietary intake of phosphate, removal of phosphate by dialysis, and reduction of intestinal phosphate absorption with phosphate binders. Lanthanum carbonate chewable tablets are phosphate binder indicated to reduce serum phosphate in patients with end- stage renal disease (ESRD). ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 69097-934
- What is NDC 69097-934?
- 69097-934 is the product NDC for Lanthanum carbonate, Lanthanum carbonate 500 mg/1 tablet, chewable, listed with the FDA by Cipla USA Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Lanthanum carbonate.
- What is the active ingredient?
- Lanthanum carbonate.
- Who is the labeler?
- Cipla USA Inc., NDC labeler code 69097. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Lanthanum carbonate?
- 16 other product NDCs are listed under this name. See all Lanthanum carbonate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Lanthanum carbonate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Lanthanum Carbonate | Lanthanum carbonate 500 mg/1 | Tablet, ChewableOral | Ascend Laboratories, LLC | 67877-256 | 67877-0256-90 |
| Lanthanum Carbonate | Lanthanum carbonate 750 mg/1 | Tablet, ChewableOral | Ascend Laboratories, LLC | 67877-257 | 67877-0257-90 |
| Lanthanum Carbonate | Lanthanum carbonate 1000 mg/1 | Tablet, ChewableOral | Ascend Laboratories, LLC | 67877-258 | 67877-0258-90 |
| Lanthanum carbonate | Lanthanum carbonate 500 mg/1 | Tablet, ChewableOral | Teva Pharmaceuticals USA, Inc. | 0093-5938 | 00093-5938-98 |
| Lanthanum carbonate | Lanthanum carbonate 750 mg/1 | Tablet, ChewableOral | Teva Pharmaceuticals USA, Inc. | 0093-5939 | 00093-5939-98 |
| Lanthanum carbonate | Lanthanum carbonate 750 mg/1 | Tablet, ChewableOral | Cipla USA Inc. | 69097-935 | 69097-0935-98 |
| Lanthanum carbonate | Lanthanum carbonate 1000 mg/1 | Tablet, ChewableOral | Cipla USA Inc. | 69097-936 | 69097-0936-98 |
| Lanthanum carbonate | Lanthanum carbonate 500 mg/1 | Tablet, ChewableOral | Exelan Pharmaceuticals, Inc. | 76282-476 | 76282-0476-90 |
| Lanthanum carbonate | Lanthanum carbonate 750 mg/1 | Tablet, ChewableOral | Exelan Pharmaceuticals, Inc. | 76282-477 | 76282-0477-90 |
| Lanthanum carbonate | Lanthanum carbonate 1000 mg/1 | Tablet, ChewableOral | Exelan Pharmaceuticals, Inc. | 76282-478 | 76282-0478-90 |
Other NDCs under ANDA 206868
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 |
|---|---|---|---|---|
| Lanthanum carbonate | Lanthanum carbonate 750 mg/1 | Tablet, ChewableOral | Cipla USA Inc. | 69097-935 |
| Lanthanum carbonate | Lanthanum carbonate 1000 mg/1 | Tablet, ChewableOral | Cipla USA Inc. | 69097-936 |
| Lanthanum carbonate | Lanthanum carbonate 500 mg/1 | Tablet, ChewableOral | Exelan Pharmaceuticals, Inc. | 76282-476 |
| Lanthanum carbonate | Lanthanum carbonate 750 mg/1 | Tablet, ChewableOral | Exelan Pharmaceuticals, Inc. | 76282-477 |
| Lanthanum carbonate | Lanthanum carbonate 1000 mg/1 | Tablet, ChewableOral | Exelan Pharmaceuticals, Inc. | 76282-478 |