Prescription drug · NDA
Endari (Glutamine) NDC 42457-420
Glutamine 5 g/1 · Powder, For solution · Oral · Emmaus Medical, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42457-420-60 | 42457042060 | 60 PACKET in 1 CARTON (42457-420-60) / 1 POWDER, FOR SOLUTION in 1 PACKET (42457-420-01)Marketed from Jul 7, 2017 |
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)
- Endari
- Generic name (nonproprietary)
- glutamine
- Active ingredients
- Glutamine — 5 g/1
- Dosage form
- Powder, For solution
- Route
- Oral
- Labeler
- Emmaus Medical, Inc.NDC labeler code 42457
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 208587
- Marketing start
- Listing expires
- Other FDA classes
- Amino Acids (Chemical structure)
- Identifiers
- Product ID 42457-420_10f5d160-6687-44d5-a607-6bf69a7312b6SPL ID 10f5d160-6687-44d5-a607-6bf69a7312b6SPL set ID d5a783f4-12ef-4326-8faa-40018e45ba3bRxCUI 1869684, 1928941UNII 0RH81L854J
- Pharmacologic class
- Amino Acid
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
N442457042060followed by a unit qualifier and the quantityPackage 42457-0420-60. 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)
Endari is indicated to reduce the acute complications of sickle cell disease in adult and pediatric patients 5 years of age and older. ENDARI is an amino acid indicated to reduce the acute complications of sickle cell disease in adult and pediatric patients 5 years of age and older. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 42457-420
- What is NDC 42457-420?
- 42457-420 is the product NDC for Endari (glutamine), Glutamine 5 g/1 powder, for solution, listed with the FDA by Emmaus Medical, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Endari (Glutamine).
- What is the active ingredient?
- Glutamine.
- Who is the labeler?
- Emmaus Medical, Inc., NDC labeler code 42457. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Endari?
- 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.