Prescription drug · NDA
Olpruva (Sodium phenylbutyrate) NDC 72542-667
Kit · Oral · Acer Therapeutics Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72542-667-18 | 72542066718 | 90 BOX in 1 CARTON (72542-667-18) / 1 KIT in 1 BOX (72542-667-02) * 1 FOR SUSPENSION in 1 PACKET (72542-367-01) * 1 FOR SUSPENSION in 1 PACKET (72542-000-01) * 1 FOR SUSPENSION in 1 PACKET (72542-003-01)Marketed from Dec 22, 2022 |
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)
- Olpruva
- Generic name (nonproprietary)
- sodium phenylbutyrate
- Dosage form
- Kit
- Route
- Oral
- Labeler
- Acer Therapeutics Inc.NDC labeler code 72542
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 214860
- Marketing start
- Listing expires
- Identifiers
- Product ID 72542-667_7720f74d-f161-4aaa-a421-7bf48e6c962cSPL ID 7720f74d-f161-4aaa-a421-7bf48e6c962c
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
N472542066718followed by a unit qualifier and the quantityPackage 72542-0667-18. 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.
About NDC 72542-667
- What is NDC 72542-667?
- 72542-667 is the product NDC for Olpruva (sodium phenylbutyrate) kit, listed with the FDA by Acer Therapeutics Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Olpruva (Sodium phenylbutyrate).
- Who is the labeler?
- Acer Therapeutics Inc., NDC labeler code 72542. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Olpruva?
- 5 other product NDCs are listed under this name. See all Olpruva NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Olpruva products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Olpruvasodium phenylbutyrate | — | KitOral | Acer Therapeutics Inc. | 72542-200 | 72542-0200-09 |
| Olpruvasodium phenylbutyrate | — | KitOral | Acer Therapeutics Inc. | 72542-300 | 72542-0300-09 |
| Olpruvasodium phenylbutyrate | — | KitOral | Acer Therapeutics Inc. | 72542-400 | 72542-0400-18 |
| Olpruvasodium phenylbutyrate | — | KitOral | Acer Therapeutics Inc. | 72542-500 | 72542-0500-18 |
| Olpruvasodium phenylbutyrate | — | KitOral | Acer Therapeutics Inc. | 72542-600 | 72542-0600-18 |
Other NDCs under NDA 214860
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 |
|---|---|---|---|---|
| Olpruvasodium phenylbutyrate | — | KitOral | Acer Therapeutics Inc. | 72542-200 |
| Olpruvasodium phenylbutyrate | — | KitOral | Acer Therapeutics Inc. | 72542-300 |
| Olpruvasodium phenylbutyrate | — | KitOral | Acer Therapeutics Inc. | 72542-400 |
| Olpruvasodium phenylbutyrate | — | KitOral | Acer Therapeutics Inc. | 72542-500 |
| Olpruvasodium phenylbutyrate | — | KitOral | Acer Therapeutics Inc. | 72542-600 |