NDC codes

FDA NDC Directory
Product NDC (as listed)42457-420Labeler and product segments. Claims need a package NDC.
Product NDC at billing width42457-0420Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
42457-420-604245704206060 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

N442457042060 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

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.

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