Metformin Hydrochloride
- Product NDC
- 68094-804
- 11-digit product format
- 680940804
- Labeler code
- 68094
- Product ID
- 68094-804_6dc13e06-f6e2-4478-9981-212f5ae23b4c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metformin Hydrochloride
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Precision Dose, Inc.
- Application
- ANDA078321
- Marketing category
- ANDA
- Marketing start
- 2024-02-15
- Substance
- METFORMIN HYDROCHLORIDE
- Active strength
- 750 mg/1
- 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
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| METFORMIN HYDROCHLORIDE | 750 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 786Z46389E |
| Rxcui | 860975, 860981 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68094-804-50 | Metformin Hydrochloride | 100 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 100 | | 5 |
| 68094-804-60 | Metformin Hydrochloride | 500 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 500 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68094-804 | METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [PRECISION DOSE, INC.] | 1 | Current NDC, 2 package rows | 20240215_60142fb2-16da-4f54-a542-74f9a70b9c8b.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 68094-804-50 | 68094080450 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68094-804-50) | 2024-02-15 | No | No | Current |
| 68094-804-60 | 68094080460 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (68094-804-60) | 2024-02-15 | No | No | Current |