Prescription drug · ANDA
Pyridoxine Hydrochloride NDC 63323-180
Pyridoxine hydrochloride 100 mg/mL · Injection, Solution · Intramuscular, Intravenous · Fresenius Kabi USA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63323-180-01 | 63323018001 | 25 VIAL in 1 TRAY (63323-180-01) / 1 mL in 1 VIAL (63323-180-00)Marketed from Sep 5, 2000 |
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)
- Pyridoxine Hydrochloride
- Generic name (nonproprietary)
- pyridoxine hydrochloride
- Active ingredients
- Pyridoxine hydrochloride — 100 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intramuscular, Intravenous
- Labeler
- Fresenius Kabi USA, LLCNDC labeler code 63323
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 080618
- Marketing start
- Listing expires
- Other FDA classes
- Analogs/Derivatives (Chemical/Ingredient)Vitamin B 6 (Chemical/Ingredient)
- Identifiers
- Product ID 63323-180_621c0b5c-be50-4bb5-9475-6acba6114cbeSPL ID 621c0b5c-be50-4bb5-9475-6acba6114cbeSPL set ID a56d11c0-b033-4201-85ff-fc710506481aRxCUI 312736UNII 68Y4CF58BV
- Pharmacologic class
- Vitamin B6 Analog
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
N463323018001followed by a unit qualifier and the quantityPackage 63323-0180-01. 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 .
Indications (excerpt from the label)
INDICATIONS AND USAGE: Pyridoxine Hydrochloride Injection is effective for the treatment of pyridoxine deficiency as seen in the following: Inadequate dietary intake. Drug-induced deficiency, as from isoniazid (INH) or oral contraceptives. Inborn errors of metabolism, e.g., vitamin B 6 dependent convulsions or vitamin B 6 responsive anemia. The parenteral route is indicated when oral administration is not feasible as in anorexia, nausea and vomiting, and preoperative and postoperative conditions. It is also indicated when gastrointestinal absorption is impaired.
Excerpt only. Read the full label for complete information.
About NDC 63323-180
- What is NDC 63323-180?
- 63323-180 is the product NDC for Pyridoxine Hydrochloride, Pyridoxine hydrochloride 100 mg/mL injection, solution, listed with the FDA by Fresenius Kabi USA, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Pyridoxine Hydrochloride.
- What is the active ingredient?
- Pyridoxine hydrochloride.
- Who is the labeler?
- Fresenius Kabi USA, LLC, NDC labeler code 63323. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Pyridoxine Hydrochloride?
- 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.
Other NDCs under ANDA 080618
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 |
|---|---|---|---|---|
| Pyridoxine Hci | Pyridoxine hydrochloride 100 mg/mL | Injection, SolutionIntramuscular, Intravenous | HF Acquisition Co LLC, DBA HealthFirst | 51662-1410 |