Thiamine Hydrochloride
- Product NDC
- 71288-804
- 11-digit product format
- 712880804
- Labeler code
- 71288
- Product ID
- 71288-804_ab453c44-b01b-4500-82b1-865d5ab1aa03
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Thiamine Hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Meitheal Pharmaceuticals Inc.
- Application
- ANDA213131
- Marketing category
- ANDA
- Marketing start
- 2026-09-25
- Substance
- THIAMINE HYDROCHLORIDE
- Active strength
- 100 mg/mL
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Source provenance: Browse the complete Orange Book source catalog.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Thiamine Hydrochloride
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| THIAMINE HYDROCHLORIDE | 100 mg/mL |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 71288-804-03 | 71288080403 | 25 VIAL, MULTI-DOSE in 1 CARTON (71288-804-03) / 2 mL in 1 VIAL, MULTI-DOSE (71288-804-02) | 2026-09-25 | No | No | Current |