Metformin Hydrochloride Oral Solution
- Product NDC
- 42571-360
- 11-digit product format
- 425710360
- Labeler code
- 42571
- Product ID
- 42571-360_4d2a345b-54cc-2188-e063-6294a90ac6bf
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metformin Hydrochloride
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- MICRO LABS LIMITED
- Application
- ANDA211309
- Marketing category
- ANDA
- Marketing start
- 2020-04-20
- Substance
- METFORMIN HYDROCHLORIDE
- Active strength
- 500 mg/5mL
- Pharmacologic classes
- Biguanide [EPC], Biguanides [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Metformin Hydrochloride Oral Solution
- Listing expiration
- 2027-12-31
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#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 42571-360-07 | Metformin Hydrochloride Oral Solution | 473 mL in 1 BOTTLE | SOLUTION | 473 | | 5 |
| 42571-360-10 | Metformin Hydrochloride Oral Solution | 118 mL in 1 BOTTLE | SOLUTION | 118 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42571-360 | METFORMIN HYDROCHLORIDE ORAL SOLUTION (METFORMIN HYDROCHLORIDE) SOLUTION [MICRO LABS LIMITED] | 3 | Current NDC, Legacy NDC, 2 package rows | 20241228_fb90693a-074a-45be-94f4-ed6298b1f4e4.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 |
|---|
| 42571-360-07 | 42571036007 | 473 mL in 1 BOTTLE (42571-360-07) | 473 ml | 2020-04-20 | 0000-00-00 | No | No | Current |
| 42571-360-10 | 42571036010 | 118 mL in 1 BOTTLE (42571-360-10) | 118 ml | 2020-04-20 | 0000-00-00 | No | No | Current |