thiamine hydrochloride
- Product NDC
- 68083-567
- 11-digit product format
- 680830567
- Labeler code
- 68083
- Product ID
- 68083-567_809c6495-dfc8-4a9e-ab98-9a5e607075ab
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- thiamine hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Gland Pharma Limited
- Application
- ANDA217800
- Marketing category
- ANDA
- Marketing start
- 2025-02-24
- Substance
- THIAMINE HYDROCHLORIDE
- Active strength
- 200 mg/2mL
- 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 | 200 mg/2mL |
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 |
|---|
| 68083-567-25 | thiamine hydrochloride | 25 in 1 CARTON | INJECTION, SOLUTION | 25 | | 3 |
| 68083-567-25 | thiamine hydrochloride | 2 mL in 1 VIAL | INJECTION, SOLUTION | 2 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68083-567 | THIAMINE HYDROCHLORIDE INJECTION, SOLUTION [GLAND PHARMA LIMITED] | 3 | Current NDC, 2 package rows | 20250302_fc0265cd-d13a-477c-8c2c-8d44fd86444e.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 68083-567-25 | 68083056725 | 25 VIAL in 1 CARTON (68083-567-25) / 2 mL in 1 VIAL | 25 vial | 2025-02-24 | No | No | Current |