Prescription drug · ANDA
Edetate Calcium Disodium NDC 64980-588
Edetate calcium disodium 200 mg/mL · Injection · Intramuscular, Intravenous · Rising Pharma Holdings, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 64980-588-51 | 64980058851 | 5 VIAL in 1 CARTON (64980-588-51) / 5 mL in 1 VIAL (64980-588-05)Marketed from May 3, 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)
- Edetate Calcium Disodium
- Generic name (nonproprietary)
- edetate calcium disodium
- Active ingredients
- Edetate calcium disodium — 200 mg/mL
- Dosage form
- Injection
- Route
- Intramuscular, Intravenous
- Labeler
- Rising Pharma Holdings, Inc.NDC labeler code 64980
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216435
- Marketing start
- Listing expires
- Other FDA classes
- Calcium Chelating Activity (Mechanism)Decreased Coagulation Factor Activity (Physiologic effect)Lead Chelating Activity (Mechanism)
- Identifiers
- Product ID 64980-588_ccaf3765-ff27-4127-a6be-b4d9437217d8SPL ID ccaf3765-ff27-4127-a6be-b4d9437217d8SPL set ID 710a2c8c-3620-4f6f-b8fc-fb19ab9e9f22RxCUI 847703UNII 25IH6R4SGF
- Pharmacologic class
- Anti-coagulant; Lead Chelator
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
N464980058851followed by a unit qualifier and the quantityPackage 64980-0588-51. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
INDICATIONS AND USAGE Edetate calcium disodium is indicated for the reduction of blood levels and depot stores of lead in lead poisoning (acute and chronic) and lead encephalopathy, in both pediatric populations and adults. Chelation therapy should not replace effective measures to eliminate or reduce further exposure to lead.
Excerpt only. Read the full label for complete information.
About NDC 64980-588
- What is NDC 64980-588?
- 64980-588 is the product NDC for Edetate Calcium Disodium, Edetate calcium disodium 200 mg/mL injection, listed with the FDA by Rising Pharma Holdings, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Edetate Calcium Disodium.
- What is the active ingredient?
- Edetate calcium disodium.
- Who is the labeler?
- Rising Pharma Holdings, Inc., NDC labeler code 64980. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Edetate Calcium Disodium?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.