Metformin Hydrochloride
- Product NDC
- 69367-182
- 11-digit product format
- 693670182
- Labeler code
- 69367
- Product ID
- 69367-182_67a94e43-0280-4469-a2f1-35eced77f9a7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- METFORMIN HYDROCHLORIDE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Westminster Pharmaceuticals, LLC
- Application
- ANDA203769
- Marketing category
- ANDA
- Marketing start
- 2017-11-21
- Marketing end
- 2027-01-01
- Substance
- METFORMIN HYDROCHLORIDE
- Active strength
- 1000 mg/1
- Pharmacologic classes
- Biguanide [EPC], Biguanides [CS]
- NDC exclude flag
- No
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Metformin Hydrochloride
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| METFORMIN HYDROCHLORIDE | 1000 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 786Z46389E |
| Rxcui | 861004, 861007, 861010 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 69367-182-01 | Metformin Hydrochloride | 100 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 100 | | 3 |
| 69367-182-05 | Metformin Hydrochloride | 500 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 500 | | 3 |
| 69367-182-10 | Metformin Hydrochloride | 1000 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 1000 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69367-182 | METFORMIN HYDROCHLORIDE TABLET, FILM COATED [WESTMINSTER PHARMACEUTICALS, LLC] | 2 | Current NDC, Legacy NDC, 3 package rows | 20200429_836f3647-bfef-40d1-b475-c0d240241a67.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 |
|---|
| 69367-182-01 | 69367018201 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69367-182-01) | 2017-11-21 | 2027-01-01 | No | No | Current |
| 69367-182-05 | 69367018205 | 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69367-182-05) | 2017-11-21 | 2027-01-01 | No | No | Current |
| 69367-182-10 | 69367018210 | 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69367-182-10) | 2020-04-21 | 2027-01-01 | No | No | Current |