Prescription drug · UNAPPROVED DRUG OTHER
Phenobarbital Oral Solution (Phenobarbital oral) NDC 54288-163
Phenobarbital 20 mg/5mL · Solution · Oral · BPI Labs LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 54288-163-47 | 5428801634754288016347 | 473 mL in 1 BOTTLE, PLASTIC (54288-163-47)Marketed from Oct 27, 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)
- Phenobarbital Oral Solution
- Generic name (nonproprietary)
- phenobarbital oral
- Active ingredients
- Phenobarbital — 20 mg/5mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- BPI Labs LLCNDC labeler code 54288
- Product type
- Prescription drug
- Marketing category
- Unapproved drug (other)
- Marketing start
- Listing expires
- DEA schedule
- CIV
- Identifiers
- Product ID 54288-163_7c47a17d-2865-4db3-856d-5b283b8eae21SPL ID 7c47a17d-2865-4db3-856d-5b283b8eae21SPL set ID 45f6317e-cfc9-4ec9-84c9-72daa6c68911RxCUI 702519UNII YQE403BP4DUPC 0354288163477
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
N454288016347followed by a unit qualifier and the quantityPackage 54288-0163-47. 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)
INDICATIONS USAGE A. Sedative B. Anticonvulsant - For the treatment of generalized and partial seizures.
Excerpt only. Read the full label for complete information.
About NDC 54288-163
- What is NDC 54288-163?
- 54288-163 is the product NDC for Phenobarbital Oral Solution (phenobarbital oral), Phenobarbital 20 mg/5mL solution, listed with the FDA by BPI Labs LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Phenobarbital Oral Solution (Phenobarbital Oral).
- What is the active ingredient?
- Phenobarbital.
- Who is the labeler?
- BPI Labs LLC, NDC labeler code 54288. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Phenobarbital Oral Solution?
- 6 other product NDCs are listed under this name. See all Phenobarbital Oral Solution NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Phenobarbital Oral Solution products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Phenobarbital Oral Solutionphenobarbital oral | Phenobarbital 20 mg/5mL | SolutionOral | Kesin Pharma Corporation | 81033-164 | 81033-0164-47 |
| Phenobarbital Oral Solutionphenobarbital oral | Phenobarbital 20 mg/5mL | SolutionOral | Ajenat Pharmaceuticals LLC | 82983-417 | 82983-0417-47 |
| Phenobarbital Oral Solutionphenobarbital oral | Phenobarbital 20 mg/5mL | SolutionOral | Kesin Pharma Corporation | 81033-163 | 81033-0163-54 |
| Phenobarbital Oral Solutionphenobarbital oral | Phenobarbital 20 mg/5mL | SolutionOral | PAI Holdings, LLC dba PAI Pharma | 0121-0942 | 00121-0942-1600121-0942-50 |
| Phenobarbital Oral Solutionphenobarbital oral | Phenobarbital 30 mg/7.5mL | SolutionOral | PAI Holdings, LLC dba PAI Pharma | 0121-1884 | 00121-1884-50 |
| Phenobarbital Oral Solutionphenobarbital oral | Phenobarbital 60 mg/15mL | SolutionOral | PAI Holdings, LLC dba PAI Pharma | 0121-2826 | 00121-2826-50 |