Sapropterin Dihydrochloride NDC 49884-948

NDC codes

FDA NDC Directory

Product NDC (as listed)49884-948Labeler and product segments. Claims need a package NDC.

Product NDC at billing width49884-0948Add 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 NDC	11-digit (billing)	Package	Copy
49884-948-72	49884094872	30 PACKET in 1 CARTON (49884-948-72) / 1 POWDER, FOR SOLUTION in 1 PACKET (49884-948-52)Marketed from Oct 1, 2020

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): Sapropterin Dihydrochloride
Generic name (nonproprietary): sapropterin dihydrochloride
Active ingredients: Sapropterin dihydrochloride — 100 mg/1
Dosage form: Powder, For solution
Route: Oral
Labeler: Par Health USA, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 207207
Marketing start: Oct 1, 2020
Listing expires: Dec 31, 2027
Other FDA classes: Breast Cancer Resistance Protein Inhibitors (Mechanism)P-Glycoprotein Inhibitors (Mechanism)Phenylalanine Hydroxylase Activators (Mechanism)
Identifiers: Product ID 49884-948_a5e80731-b1bc-4c44-9cfb-0c4c80eb1b0fSPL ID a5e80731-b1bc-4c44-9cfb-0c4c80eb1b0fSPL set ID 6b2172e4-42fc-42fe-b1ad-9d6a974d4343RxCUI 1111018UNII RG277LF5B3UPC 0349884948726
Pharmacologic class: Phenylalanine Hydroxylase Activator

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

N449884094872 followed by a unit qualifier and the quantity

Package 49884-0948-72. 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

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