Metformin Hydrochloride Oral Solution
- Product NDC
- 52817-820
- 11-digit product format
- 528170820
- Labeler code
- 52817
- Product ID
- 52817-820_2a4320c6-8080-9ddc-e063-6294a90aa921
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metformin Hydrochloride
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- TRUPHARMA, LLC
- Application
- ANDA211309
- Marketing category
- ANDA
- Marketing start
- 2022-01-25
- Substance
- METFORMIN HYDROCHLORIDE
- Active strength
- 500 mg/5mL
- Pharmacologic classes
- Biguanide [EPC], Biguanides [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Metformin Hydrochloride Oral Solution
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| METFORMIN HYDROCHLORIDE | 500 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 786Z46389E |
| Rxcui | 861025 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 52817-820-50 | Metformin Hydrochloride Oral Solution | 10 in 1 TRAY | SOLUTION | 10 | | 2 |
| 52817-820-50 | Metformin Hydrochloride Oral Solution | 5 in 1 CASE | SOLUTION | 5 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 52817-820 | METFORMIN HYDROCHLORIDE ORAL SOLUTION (METFORMIN HYDROCHLORIDE) SOLUTION [TRUPHARMA, LLC] | 2 | Current NDC, Legacy NDC, 2 package rows | 20241228_73691c6c-8841-4c5d-b4a5-c3ed3b5effa1.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 |
|---|
| 52817-820-50 | 52817082050 | 5 TRAY in 1 CASE (52817-820-50) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE | 5 tray | 2022-01-25 | 0000-00-00 | No | No | Current |