Prescription drug · ANDA
Thiamine (Thiamine hydrochloride) NDC 63323-013
Thiamine hydrochloride 100 mg/mL · Injection, Solution · Intramuscular, Intravenous · Fresenius Kabi USA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63323-013-02 | 63323001302 | 25 VIAL, MULTI-DOSE in 1 TRAY (63323-013-02) / 2 mL in 1 VIAL, MULTI-DOSE (63323-013-01)Marketed from Sep 1, 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)
- Thiamine
- Generic name (nonproprietary)
- thiamine hydrochloride
- Active ingredients
- Thiamine 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 080556
- Marketing start
- Listing expires
- Identifiers
- Product ID 63323-013_3bda958c-8ec2-4039-a7f0-96e2b94f9c26SPL ID 3bda958c-8ec2-4039-a7f0-96e2b94f9c26SPL set ID ca4899c6-cea1-48d6-b0ae-9efcf67f6fcbRxCUI 313324UNII M572600E5PUPC 0363323013011
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
N463323001302followed by a unit qualifier and the quantityPackage 63323-0013-02. 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)
INDICATIONS: Thiamine hydrochloride injection is effective for the treatment of thiamine deficiency or beriberi whether of the dry (major symptoms related to the nervous system) or wet (major symptoms related to the cardiovascular system) variety. Thiamine hydrochloride injection should be used where rapid restoration of thiamine is necessary, as in Wernicke’s encephalopathy, infantile beriberi with acute collapse, cardiovascular disease due to thiamine deficiency, or neuritis of pregnancy if vomiting is severe. It is also indicated when giving IV dextrose to individuals with marginal thiamine status to avoid precipitation of heart failure. Thiamine hydrochloride injection is also indicated …
Excerpt only. Read the full label for complete information.
About NDC 63323-013
- What is NDC 63323-013?
- 63323-013 is the product NDC for Thiamine (thiamine hydrochloride), Thiamine 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?
- Thiamine (Thiamine hydrochloride).
- What is the active ingredient?
- Thiamine 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 Thiamine?
- 5 other product NDCs are listed under this name. See all Thiamine NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Thiamine products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Thiaminethiamine hydrochloride | Thiamine hydrochloride 100 mg/mL | Injection, SolutionIntramuscular, Intravenous | Caplin Steriles Limited | 65145-129 | 65145-0129-25 |
| Thiaminethiamine hydrochloride | Thiamine hydrochloride 100 mg/mL | Injection, SolutionIntramuscular, Intravenous | Armas Pharmaceuticals Inc. | 72485-507 | 72485-0507-25 |
| Thiaminethiamine hydrochloride | Thiamine hydrochloride 100 mg/mL | Injection, SolutionIntramuscular, Intravenous | NorthStar Rx LLC | 72603-139 | 72603-0139-25 |
Other NDCs under ANDA 080556
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 |
|---|---|---|---|---|
| THIAMINE HCl | Thiamine hydrochloride 100 mg/mL | Injection, SolutionIntramuscular, Intravenous | HF Acquisition Co LLC, DBA HealthFirst | 51662-1523 |