Prescription drug · ANDA
Thiamine (Thiamine hydrochloride) NDC 72485-507
Thiamine hydrochloride 100 mg/mL · Injection, Solution · Intramuscular, Intravenous · Armas Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72485-507-25 | 7248505072572485050725 | 25 VIAL, MULTI-DOSE in 1 CARTON (72485-507-25) / 2 mL in 1 VIAL, MULTI-DOSE (72485-507-01)Marketed from May 22, 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
- Armas Pharmaceuticals Inc.NDC labeler code 72485
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215692
- Marketing start
- Listing expires
- Identifiers
- Product ID 72485-507_9ecbf165-bd2e-4bc1-a52c-1f40d1c2bbd9SPL ID 9ecbf165-bd2e-4bc1-a52c-1f40d1c2bbd9SPL set ID 9ecbf165-bd2e-4bc1-a52c-1f40d1c2bbd9RxCUI 313324UNII M572600E5PUPC 0372485507016
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
N472485050725followed by a unit qualifier and the quantityPackage 72485-0507-25. 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.
About NDC 72485-507
- What is NDC 72485-507?
- 72485-507 is the product NDC for Thiamine (thiamine hydrochloride), Thiamine hydrochloride 100 mg/mL injection, solution, listed with the FDA by Armas Pharmaceuticals Inc.. 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?
- Armas Pharmaceuticals Inc., NDC labeler code 72485. 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?
- 3 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 | NorthStar Rx LLC | 72603-139 | 72603-0139-25 |
| Thiaminethiamine hydrochloride | Thiamine hydrochloride 100 mg/mL | Injection, SolutionIntramuscular, Intravenous | Fresenius Kabi USA, LLC | 63323-013 | 63323-0013-02 |
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 | NorthStar Rx LLC | 72603-139 |