NDC codes

FDA NDC Directory
Product NDC (as listed)13551-003Labeler and product segments. Claims need a package NDC.
Product NDC at billing width13551-0003Add 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
13551-003-07135510003077 PACKET in 1 CARTON (13551-003-07) / 1 FOR SUSPENSION, EXTENDED RELEASE in 1 PACKETMarketed from May 1, 2023
13551-003-301355100033030 PACKET in 1 CARTON (13551-003-30) / 1 FOR SUSPENSION, EXTENDED RELEASE in 1 PACKETMarketed from May 1, 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)
Lumryz
Generic name (nonproprietary)
sodium oxybate
Active ingredients
Sodium oxybate — 7.5 g/1
Dosage form
For suspension, Extended release
Route
Oral
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 214755
Marketing start
Listing expires
DEA schedule
CIII
Other FDA classes
Central Nervous System Depression (Physiologic effect)Decreased Central Nervous System Organized Electrical Activity (Physiologic effect)
Identifiers
Product ID 13551-003_0aae7705-0d32-4900-8233-0b3da243bed6SPL ID 0aae7705-0d32-4900-8233-0b3da243bed6
Pharmacologic class
Central Nervous System Depressant

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

N413551000307 followed by a unit qualifier and the quantity

Package 13551-0003-07. 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

The FDA listing for this product does not reference a label (SPL) set.

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