Prescription drug · NDA
Sezaby (Phenobarbital sodium) NDC 62756-301
Phenobarbital sodium 100 mg/1 · Injection · Intravenous · Sun Pharmaceutical Industries, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62756-301-01 | 6275603010162756030101 | 1 INJECTION in 1 VIAL, SINGLE-DOSE (62756-301-01)Marketed from Dec 26, 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)
- Sezaby
- Generic name (nonproprietary)
- phenobarbital sodium
- Active ingredients
- Phenobarbital sodium — 100 mg/1
- Dosage form
- Injection
- Route
- Intravenous
- Labeler
- Sun Pharmaceutical Industries, Inc.NDC labeler code 62756
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 215910
- Marketing start
- Listing expires
- DEA schedule
- CIV
- Identifiers
- Product ID 62756-301_842763a1-63ca-4721-b127-f997ac4aa659SPL ID 842763a1-63ca-4721-b127-f997ac4aa659SPL set ID 8c7d0402-4977-4c25-bc4b-11db91339e9aRxCUI 2624719, 2624724UNII SW9M9BB5K3UPC 0362756301016
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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N462756030101followed by a unit qualifier and the quantityPackage 62756-0301-01. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
SEZABY is indicated for the treatment of neonatal seizures in term and preterm infants. SEZABY is a barbiturate indicated for the treatment of neonatal seizures in term and preterm infants.
Excerpt only. Read the full label for complete information.
About NDC 62756-301
- What is NDC 62756-301?
- 62756-301 is the product NDC for Sezaby (phenobarbital sodium), Phenobarbital sodium 100 mg/1 injection, listed with the FDA by Sun Pharmaceutical Industries, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Sezaby (Phenobarbital sodium).
- What is the active ingredient?
- Phenobarbital sodium.
- Who is the labeler?
- Sun Pharmaceutical Industries, Inc., NDC labeler code 62756. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Sezaby?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.