Metformin Hydrochloride
- Product NDC
- 70247-019
- 11-digit product format
- 702470019
- Labeler code
- 70247
- Product ID
- 70247-019_48514b70-3b57-8897-e063-6294a90aa52f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metformin Hydrochloride Extended-Release Tablets
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Qingdao BAHEAL Pharmaceutical Co., Ltd.
- Application
- ANDA209993
- Marketing category
- ANDA
- Marketing start
- 2019-03-01
- Substance
- METFORMIN HYDROCHLORIDE
- Active strength
- 500 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 | 500 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 786Z46389E |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70247-019-60 | Metformin Hydrochloride | 60 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED, EXTENDED RE | 60 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70247-019 | METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS) TABLET, FILM COATED, EXTENDED RELEASE [QINGDAO BAHEAL PHARMACEUTICAL CO., LTD.] | 3 | Current NDC, Legacy NDC, 1 package rows | 20240123_7ea6e623-4073-4671-e053-2a91aa0a3ca3.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 70247-019-60 | 70247001960 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70247-019-60) | 2019-03-01 | 0000-00-00 | No | No | Current |