Thiamine Hydrochloride
- Product NDC
- 0641-6228
- 11-digit product format
- 006416228
- Labeler code
- 0641
- Product ID
- 0641-6228_54a057cd-6e3d-40e6-8329-98e47da7dd68
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Thiamine Hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- ANDA080575
- Marketing category
- ANDA
- Marketing start
- 2021-02-12
- Substance
- THIAMINE HYDROCHLORIDE
- Active strength
- 100 mg/mL
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Thiamine Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| THIAMINE HYDROCHLORIDE | 100 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | M572600E5P |
| Rxcui | 313324 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0641-6228-01 | Thiamine Hydrochloride | 2 mL in 1 VIAL | INJECTION, SOLUTION | 2 | | 4 |
| 0641-6228-25 | Thiamine Hydrochloride | 25 in 1 CARTON | INJECTION, SOLUTION | 25 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0641-6228 | THIAMINE HYDROCHLORIDE INJECTION, SOLUTION [HIKMA PHARMACEUTICALS USA INC.] | 4 | Current NDC, Legacy NDC, 2 package rows | 20240413_63f3631b-ba1e-430c-a30b-dd05b2c00c13.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0641-6228-01 | 00641622801 | 2 mL in 1 VIAL | 2 ml | | | | | Historical |
| 0641-6228-25 | 00641622825 | 25 VIAL in 1 CARTON (0641-6228-25) / 2 mL in 1 VIAL (0641-6228-01) | 25 vial | 2021-02-12 | 0000-00-00 | No | No | Current |