What is NDC 49884-720?

49884-720 is the product NDC for sapropterin dihydrochloride, Sapropterin dihydrochloride 100 mg/1 tablet, listed with the FDA by Par Health USA, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Par Health USA, LLC, NDC labeler code 49884. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for sapropterin dihydrochloride?

14 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

sapropterin dihydrochloride NDC 49884-720

NDC codes

FDA NDC Directory

Product NDC (as listed)49884-720Labeler and product segments. Claims need a package NDC.

Product NDC at billing width49884-0720Add 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
49884-720-08	4988407200849884072008	120 TABLET in 1 BOTTLE (49884-720-08)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: Tablet
Route: Oral
Labeler: Par Health USA, LLCNDC labeler code 49884
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 207200
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 49884-720_613f1a86-4523-4a35-ad6b-38ef403f7971SPL ID 613f1a86-4523-4a35-ad6b-38ef403f7971SPL set ID eafec3a2-4f29-4afa-8728-a62b34cefd18RxCUI 1486687UNII RG277LF5B3UPC 0349884720087
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

N449884072008 followed by a unit qualifier and the quantity

Package 49884-0720-08. 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 Apr 17, 2026.

Indications (excerpt from the label)

1. INDICATIONS AND USAGE Sapropterin dihydrochloride tablets are indicated to reduce blood phenylalanine (Phe) levels in adult and pediatric patients one month of age and older with hyperphenylalaninemia (HPA) due to tetrahydrobiopterin- (BH4-) responsive Phenylketonuria (PKU). Sapropterin dihydrochloride tablets are to be used in conjunction with a Phe-restricted diet. Sapropterin dihydrochloride tablets are a phenylalanine hydroxylase activator indicated to reduce blood phenylalanine (Phe) levels in adult and pediatric patients one month of age and older with hyperphenylalaninemia (HPA) due to tetrahydrobiopterin-(BH4-) responsive Phenylketonuria (PKU). Sapropterin dihydrochloride tablets …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 49884-720

What is NDC 49884-720?: 49884-720 is the product NDC for sapropterin dihydrochloride, Sapropterin dihydrochloride 100 mg/1 tablet, listed with the FDA by Par Health USA, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: sapropterin dihydrochloride.
What is the active ingredient?: Sapropterin dihydrochloride.
Who is the labeler?: Par Health USA, LLC, NDC labeler code 49884. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for sapropterin dihydrochloride?: 14 other product NDCs are listed under this name. See all sapropterin dihydrochloride NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other sapropterin dihydrochloride NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Sapropterin Dihydrochloride	Sapropterin dihydrochloride 100 mg/1	Powder, For solutionOral	Micro Labs Limited	42571-509	42571-0509-41
Sapropterin Dihydrochloride	Sapropterin dihydrochloride 500 mg/1	Powder, For solutionOral	Micro Labs Limited	42571-510	42571-0510-41
Sapropterin Dihydrochloride	Sapropterin dihydrochloride 100 mg/1	Powder, For solutionOral	TRUPHARMA, LLC	52817-850	52817-0850-0152817-0850-30
Sapropterin Dihydrochloride	Sapropterin dihydrochloride 500 mg/1	Powder, For solutionOral	TRUPHARMA, LLC	52817-851	52817-0851-0152817-0851-30
sapropterin dihydrochloride	Sapropterin dihydrochloride 100 mg/1	TabletOral	Hikma Pharmaceuticals USA Inc.	0054-0906	00054-0906-23
Sapropterin Dihydrochloride	Sapropterin dihydrochloride 100 mg/1	TabletOral	Aurobindo Pharma Limited	59651-574	59651-0574-0859651-0574-2459651-0574-30
sapropterin dihydrochloride	Sapropterin dihydrochloride 100 mg/1	TabletOral	NorthStar RxLLC	72603-191	72603-0191-01
Sapropterin dihydrochloride	Sapropterin dihydrochloride 100 mg/1	Powder, For solutionOral	NorthStar RxLLC	72603-193	72603-0193-30
Sapropterin dihydrochloride	Sapropterin dihydrochloride 500 mg/1	Powder, For solutionOral	NorthStar RxLLC	72603-194	72603-0194-30
sapropterin dihydrochloride	Sapropterin dihydrochloride 100 mg/1	TabletOral	Camber Pharmaceuticals, Inc.	31722-045	31722-0045-12

All 15 sapropterin dihydrochloride NDCs