Prescription drug · ANDA
Diazoxide NDC 13517-100
Diazoxide 50 mg/mL · Suspension · Oral · e5 Pharma, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 13517-100-30 | 13517010030 | 1 BOTTLE, DROPPER in 1 CARTON (13517-100-30) / 30 mL in 1 BOTTLE, DROPPERMarketed from Dec 11, 2019 |
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)
- Diazoxide
- Generic name (nonproprietary)
- diazoxide
- Active ingredients
- Diazoxide — 50 mg/mL
- Dosage form
- Suspension
- Route
- Oral
- Labeler
- e5 Pharma, LLCNDC labeler code 13517
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211050
- Marketing start
- Listing expires
- Identifiers
- Product ID 13517-100_11c83c92-145b-486a-90f3-d759c358d091SPL ID 11c83c92-145b-486a-90f3-d759c358d091SPL set ID c0237320-2d3f-4907-a4d3-08f138aa4ca8RxCUI 197593UNII O5CB12L4FNUPC 0313517100300
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
N413517010030followed by a unit qualifier and the quantityPackage 13517-0100-30. 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)
INDICATIONS AND USAGE Diazoxide Oral Suspension is indicated for the management of hypoglycemia due to hyperinsulinism associated with the following conditions: Adults: Inoperable islet cell adenoma or carcinoma, or extrapancreatic malignancy. Infants and Children: Leucine sensitivity, islet cell hyperplasia, nesidioblastosis, extrapancreatic malignancy, islet cell adenoma, or adenomatosis. Diazoxide Oral Suspension may be used preoperatively as a temporary measure, and postoperatively, if hypoglycemia persists. Diazoxide should be used only after a diagnosis of hypoglycemia due to one of the above conditions has been definitely established. When other specific medical therapy or surgical ma…
Excerpt only. Read the full label for complete information.
About NDC 13517-100
- What is NDC 13517-100?
- 13517-100 is the product NDC for Diazoxide, Diazoxide 50 mg/mL suspension, listed with the FDA by e5 Pharma, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Diazoxide.
- What is the active ingredient?
- Diazoxide.
- Who is the labeler?
- e5 Pharma, LLC, NDC labeler code 13517. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Diazoxide?
- 1 other product NDC are listed under this name. See all Diazoxide NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Diazoxide products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Diazoxide | Diazoxide 50 mg/mL | SuspensionOral | Par Health USA, LLC | 0254-1010 | 00254-1010-19 |