Prescription drug · ANDA
thiamine hydrochloride NDC 68083-567
Thiamine hydrochloride 200 mg/2mL · Injection, Solution · Intramuscular, Intravenous · Gland Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68083-567-25 | 6808305672568083056725 | 25 VIAL in 1 CARTON (68083-567-25) / 2 mL in 1 VIALMarketed from Feb 24, 2025 |
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 hydrochloride
- Generic name (nonproprietary)
- thiamine hydrochloride
- Active ingredients
- Thiamine hydrochloride — 200 mg/2mL
- Dosage form
- Injection, Solution
- Route
- Intramuscular, Intravenous
- Labeler
- Gland Pharma LimitedNDC labeler code 68083
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 217800
- Marketing start
- Listing expires
- Identifiers
- Product ID 68083-567_809c6495-dfc8-4a9e-ab98-9a5e607075abSPL ID 809c6495-dfc8-4a9e-ab98-9a5e607075abSPL set ID fc0265cd-d13a-477c-8c2c-8d44fd86444eRxCUI 313324UNII M572600E5P
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
N468083056725followed by a unit qualifier and the quantityPackage 68083-0567-25. 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 AND 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 i…
Excerpt only. Read the full label for complete information.
About NDC 68083-567
- What is NDC 68083-567?
- 68083-567 is the product NDC for thiamine hydrochloride, Thiamine hydrochloride 200 mg/2mL injection, solution, listed with the FDA by Gland Pharma Limited. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- thiamine hydrochloride.
- What is the active ingredient?
- Thiamine hydrochloride.
- Who is the labeler?
- Gland Pharma Limited, NDC labeler code 68083. 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 hydrochloride?
- 15 other product NDCs are listed under this name. See all thiamine hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other thiamine hydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Thiamine Hydrochloride | Thiamine hydrochloride 100 mg/mL | Injection, SolutionIntramuscular, Intravenous | NorthStar RxLLC | 72603-565 | 72603-0565-25 |
| Thiamine Hydrochloride | Thiamine hydrochloride 100 mg/mL | Injection, SolutionIntramuscular, Intravenous | Lifestar Pharma LLC | 70756-684 | 70756-0684-25 |
| Thiamine Hydrochloride | Thiamine hydrochloride 100 mg/mL | Injection, SolutionIntramuscular, Intravenous | Meitheal Pharmaceuticals Inc. | 71288-804 | 71288-0804-03 |
| Thiamine Hydrochloride | Thiamine hydrochloride 100 mg/mL | Injection, SolutionIntramuscular, Intravenous | ONESOURCE SPECIALTY PHARMA LIMITED | 83270-004 | 83270-0004-03 |
| Thiamine Hydrochloride | Thiamine hydrochloride 100 mg/mL | Injection, SolutionIntramuscular, Intravenous | Fosun Pharma USA Inc. | 72266-260 | 72266-0260-25 |
| Thiamine Hydrochloride | Thiamine hydrochloride 100 mg/mL | Injection, SolutionIntramuscular, Intravenous | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-933 | 23155-0933-41 |
| Thiamine Hydrochloride | Thiamine hydrochloride 100 mg/mL | Injection, SolutionIntramuscular, Intravenous | REMEDYREPACK INC. | 70518-4230 | 70518-4230-00 |
| Thiamine Hydrochloride | Thiamine hydrochloride 100 mg/mL | Injection, SolutionIntramuscular, Intravenous | Camber Pharmaceuticals, Inc. | 31722-363 | 31722-0363-32 |
| Thiamine Hydrochloride | Thiamine hydrochloride 100 mg/mL | Injection, SolutionIntramuscular, Intravenous | Henry Schein, Inc. | 0404-9799 | 00404-9799-20 |
| Thiamine Hydrochloride | Thiamine hydrochloride 100 mg/mL | Injection, SolutionIntramuscular, Intravenous | Dr. Reddy's Laboratories Inc. | 43598-050 | 43598-0050-25 |