Prescription drug · ANDA
Thiamine (thiamine hydrochloride) NDC 72603-139
Thiamine hydrochloride 100 mg/mL · Injection, Solution · Intramuscular, Intravenous · NorthStar Rx LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72603-139-25 | 72603013925 | 25 VIAL, MULTI-DOSE in 1 CARTON (72603-139-25) / 2 mL in 1 VIAL, MULTI-DOSE (72603-139-01)Marketed from Apr 20, 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)
- Thiamine
- Generic name (nonproprietary)
- thiamine hydrochloride
- Active ingredients
- Thiamine hydrochloride — 100 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intramuscular, Intravenous
- Labeler
- NorthStar Rx LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215692
- Marketing start
- Listing expires
- Identifiers
- Product ID 72603-139_f4790075-a740-4550-9d4c-69a00dac354cSPL ID f4790075-a740-4550-9d4c-69a00dac354cSPL set ID f4790075-a740-4550-9d4c-69a00dac354cRxCUI 313324UNII M572600E5PUPC 0372603139013, 0372603139259
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
N472603013925followed by a unit qualifier and the quantityPackage 72603-0139-25. 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 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 ind…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 215692
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 |
|---|---|---|---|---|
| Thiaminethiamine hydrochloride | Thiamine hydrochloride 100 mg/mL | Injection, SolutionIntramuscular, Intravenous | Caplin Steriles Limited | 65145-129 |
| Thiaminethiamine hydrochloride | Thiamine hydrochloride 100 mg/mL | Injection, SolutionIntramuscular, Intravenous | Armas Pharmaceuticals Inc. | 72485-507 |