Prescription drug · ANDA
THIAMINE HCl NDC 51662-1523
Thiamine hydrochloride 100 mg/mL · Injection, Solution · Intramuscular, Intravenous · HF Acquisition Co LLC, DBA HealthFirst
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51662-1523-1 | 5166215230151662152301 | 2 mL in 1 VIAL, MULTI-DOSE (51662-1523-1)Marketed from Jun 14, 2021 | |
| 51662-1523-3 | 5166215230351662152303 | 25 POUCH in 1 CASE (51662-1523-3) / 1 VIAL, MULTI-DOSE in 1 POUCH (51662-1523-2) / 2 mL in 1 VIAL, MULTI-DOSEMarketed from Nov 10, 2022 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 HCl
- Generic name (nonproprietary)
- thiamine hcl
- Active ingredients
- Thiamine hydrochloride — 100 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intramuscular, Intravenous
- Labeler
- HF Acquisition Co LLC, DBA HealthFirstNDC labeler code 51662
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 080556
- Marketing start
- Listing expires
- Identifiers
- Product ID 51662-1523_101e59b2-b8c3-3079-e063-6294a90a0a80SPL ID 101e59b2-b8c3-3079-e063-6294a90a0a80SPL set ID c4c436ab-cbb7-9429-e053-2995a90a58aeRxCUI 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
N451662152301followed by a unit qualifier and the quantityPackage 51662-1523-01. 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 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 i…
Excerpt only. Read the full label for complete information.
About NDC 51662-1523
- What is NDC 51662-1523?
- 51662-1523 is the product NDC for THIAMINE HCl, Thiamine hydrochloride 100 mg/mL injection, solution, listed with the FDA by HF Acquisition Co LLC, DBA HealthFirst. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- THIAMINE HCl.
- What is the active ingredient?
- Thiamine hydrochloride.
- Who is the labeler?
- HF Acquisition Co LLC, DBA HealthFirst, NDC labeler code 51662. 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 HCl?
- 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 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 |
|---|---|---|---|---|
| Thiaminethiamine hydrochloride | Thiamine hydrochloride 100 mg/mL | Injection, SolutionIntramuscular, Intravenous | Fresenius Kabi USA, LLC | 63323-013 |