Prescription drug · NDA
Orladeyo (berotralstat hydrochloride) NDC 72769-112
Berotralstat hydrochloride 96 mg/1 · Pellet · Oral · BioCryst Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72769-112-02 | 72769011202 | 4 DOSE PACK in 1 CARTON (72769-112-02) / 7 PACKET in 1 DOSE PACK / 16 PELLET in 1 PACKETMarketed from Dec 12, 2025 |
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)
- Orladeyo
- Generic name (nonproprietary)
- berotralstat hydrochloride
- Active ingredients
- Berotralstat hydrochloride — 96 mg/1
- Dosage form
- Pellet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 219776
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 2D6 Inhibitors (Mechanism)Cytochrome P450 3A4 Inhibitors (Mechanism)Kallikrein Inhibitors (Mechanism)P-Glycoprotein Inhibitors (Mechanism)
- Identifiers
- Product ID 72769-112_3235d554-689b-47e6-9b28-032b051423e2SPL ID 3235d554-689b-47e6-9b28-032b051423e2SPL set ID 3527ece1-e7e0-40b1-b0c5-6baeb0deabebRxCUI 2467565, 2467571, 2467573, 2467575, 2728874, 2728878, 2728880, 2728882, 2728884, 2728886, 2728888, 2728890UNII 88SH1NBL2B
- Pharmacologic class
- Plasma Kallikrein Inhibitor
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
N472769011202followed by a unit qualifier and the quantityPackage 72769-0112-02. 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)
ORLADEYO ® is indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adults and pediatric patients 2 years of age and older. ORLADEYO is a plasma kallikrein inhibitor indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adults and pediatric patients 2 years and older. ( 1 ) Limitations of Use : ORLADEYO should not be used for treatment of acute HAE attacks. ( 1 ) Limitations of Use : The safety and effectiveness of ORLADEYO for the treatment of acute HAE attacks have not been established. ORLADEYO should not be used for treatment of acute HAE attacks. Additional doses or doses of ORLADEYO higher than the prescribed once-daily dose are not rec…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 219776
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Orladeyoberotralstat hydrochloride | Berotralstat hydrochloride 108 mg/1 | PelletOral | BioCryst Pharmaceuticals, Inc. | 72769-113 |
| Orladeyoberotralstat hydrochloride | Berotralstat hydrochloride 72 mg/1 | PelletOral | BioCryst Pharmaceuticals, Inc. | 72769-111 |
| Orladeyoberotralstat hydrochloride | Berotralstat hydrochloride 132 mg/1 | PelletOral | BioCryst Pharmaceuticals, Inc. | 72769-114 |