Metformin Hydrochloride Oral Solution
- Product NDC
- 71656-017
- 11-digit product format
- 716560017
- Labeler code
- 71656
- Product ID
- 71656-017_29f72dd3-74fc-29f4-e063-6294a90a4755
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metformin Hydrochloride
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Saptalis Pharmaceuticals, LLC.
- Application
- ANDA211309
- Marketing category
- ANDA
- Marketing start
- 2024-07-31
- 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 |
|---|
| 71656-017-04 | Metformin Hydrochloride Oral Solution | 118 mL in 1 BOTTLE | SOLUTION | 118 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71656-017 | METFORMIN HYDROCHLORIDE ORAL SOLUTION (METFORMIN HYDROCHLORIDE) SOLUTION [SAPTALIS PHARMACEUTICALS, LLC.] | 6 | Current NDC, 1 package rows | 20241225_df61d56e-18ff-404c-b671-42b39aa23574.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 |
|---|
| 71656-017-04 | 71656001704 | 118 mL in 1 BOTTLE (71656-017-04) | 118 ml | 2024-07-31 | No | No | Current |