Metformin hydrochloride
- Product NDC
- 33342-143
- 11-digit product format
- 333420143
- Labeler code
- 33342
- Product ID
- 33342-143_3ce6010c-10dd-4e6f-9517-d71c0489a7c5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metformin hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Macleods Pharmaceuticals Limited
- Application
- ANDA205330
- Marketing category
- ANDA
- Marketing start
- 2017-11-01
- Substance
- METFORMIN HYDROCHLORIDE
- Active strength
- 1000 mg/1
- 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
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| METFORMIN HYDROCHLORIDE | 1000 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 786Z46389E |
| Rxcui | 860975, 860981, 861004, 861007, 861010 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 33342-143-10 | Metformin hydrochloride | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 6 |
| 33342-143-11 | Metformin hydrochloride | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 6 |
| 33342-143-44 | Metformin hydrochloride | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 6 |
| 33342-143-10 | Metformin Hydrochloride | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 1 |
| 33342-143-11 | Metformin Hydrochloride | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 1 |
| 33342-143-44 | Metformin Hydrochloride | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 33342-143 | METFORMIN HYDROCHLORIDE TABLET, FILM COATED METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [MACLEODS PHARMACEUTICALS LIMITED] | 6 | Current NDC, Legacy NDC, 3 package rows | 20230204_623b3bc6-1b07-4a04-bc7a-7fc695adf063.zip |
| 33342-143 | METFORMIN HYDROCHLORIDE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] | 1 | Current NDC, Legacy NDC, 3 package rows | 20180216_b8f22f07-c6b2-4d0d-85c5-573bc6f0d1b0.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 33342-143-10 | 33342014310 | 90 TABLET, FILM COATED in 1 BOTTLE (33342-143-10) | 2017-11-01 | No | No | Historical |
| 33342-143-11 | 33342014311 | 100 TABLET, FILM COATED in 1 BOTTLE (33342-143-11) | 2017-11-01 | No | No | Historical |
| 33342-143-44 | 33342014344 | 1000 TABLET, FILM COATED in 1 BOTTLE (33342-143-44) | 2017-11-01 | No | No | Historical |