Thiamine
- Product NDC
- 63323-013
- 11-digit product format
- 633230013
- Labeler code
- 63323
- Product ID
- 63323-013_3b09217b-e746-4523-95fa-b78fad431e32
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- THIAMINE HYDROCHLORIDE
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Fresenius Kabi USA, LLC
- Application
- ANDA080556
- Marketing category
- ANDA
- Marketing start
- 2000-09-01
- Substance
- THIAMINE HYDROCHLORIDE
- Active strength
- 100 mg/mL
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Thiamine
- Listing expiration
- 2027-12-31
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 |
|---|
| 63323-013-01 | Thiamine | 2 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 2 | | 6 |
| 63323-013-02 | Thiamine | 25 in 1 TRAY | INJECTION, SOLUTION | 25 | | 6 |
| 63323-013-09 | Thiamine | 25 in 1 TRAY | INJECTION, SOLUTION | 25 | | 5 |
| 63323-013-21 | Thiamine | 2 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 2 | | 5 |
| 63323-013-26 | Thiamine | 25 in 1 TRAY | INJECTION, SOLUTION | 25 | | 3 |
| 63323-013-41 | Thiamine | 2 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 2 | | 3 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| THIAMINE HYDROCHLORIDE | ACTIVE INGREDIENT | M572600E5P | THIAMINE (THIAMINE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 2 | |
| THIAMINE ION | ACTIVE MOIETY | 4ABT0J945J | THIAMINE (THIAMINE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 2 | |
| CHLOROBUTANOL | INACTIVE INGREDIENT | HM4YQM8WRC | THIAMINE (THIAMINE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 2 | |
| MONOTHIOGLYCEROL | INACTIVE INGREDIENT | AAO1P0WSXJ | THIAMINE (THIAMINE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 2 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | THIAMINE (THIAMINE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 2 | |
| Thiamine Hydrochloride | ACTIVE INGREDIENT | M572600E5P | THIAMINE HYDROCHLORIDE INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| THIAMINE HYDROCHLORIDE | ACTIVE INGREDIENT | M572600E5P | THIAMINE (THIAMINE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 1 | |
| Thiamine | ACTIVE MOIETY | X66NSO3N35 | THIAMINE HYDROCHLORIDE INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| THIAMINE ION | ACTIVE MOIETY | 4ABT0J945J | THIAMINE (THIAMINE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 1 | |
| CHLOROBUTANOL | INACTIVE INGREDIENT | HM4YQM8WRC | THIAMINE (THIAMINE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 1 | |
| MONOTHIOGLYCEROL | INACTIVE INGREDIENT | AAO1P0WSXJ | THIAMINE (THIAMINE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 1 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | THIAMINE (THIAMINE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63323-013 | THIAMINE (THIAMINE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 5 | Current NDC, Legacy NDC, 2 package rows | 20241017_ca4899c6-cea1-48d6-b0ae-9efcf67f6fcb.zip |
| 63323-013 | THIAMINE (THIAMINE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 4 | Current NDC, Legacy NDC, 2 package rows | 20241017_c3c9db74-95d4-487c-90c3-c810786fbaec.zip |
| 63323-013 | THIAMINE (THIAMINE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 2 | Current NDC, Legacy NDC, 2 package rows | 20200527_af3f9344-f743-4bad-b319-53b96e13fee2.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 |
|---|
| 63323-013-01 | 63323001301 | 2 mL in 1 VIAL, MULTI-DOSE | 2 ml | | | | | Historical |
| 63323-013-02 | 63323001302 | 25 VIAL, MULTI-DOSE in 1 TRAY (63323-013-02) / 2 mL in 1 VIAL, MULTI-DOSE (63323-013-01) | | 2000-09-01 | 0000-00-00 | No | No | Current |
| 63323-013-09 | 63323001309 | 25 VIAL, MULTI-DOSE in 1 TRAY (63323-013-09) / 2 mL in 1 VIAL, MULTI-DOSE (63323-013-21) | | 2000-09-01 | 0000-00-00 | No | No | Current |
| 63323-013-21 | 63323001321 | 2 mL in 1 VIAL, MULTI-DOSE | 2 ml | | | | | Historical |
| 63323-013-26 | 63323001326 | 25 VIAL, MULTI-DOSE in 1 TRAY (63323-013-26) / 2 mL in 1 VIAL, MULTI-DOSE (63323-013-41) | | 2000-09-01 | 0000-00-00 | No | No | Current |
| 63323-013-41 | 63323001341 | 2 mL in 1 VIAL, MULTI-DOSE | 2 ml | | | | | Historical |