Metformin Hydrochloride
- Product NDC
- 70934-788
- 11-digit product format
- 709340788
- Labeler code
- 70934
- Product ID
- 70934-788_be26137f-8312-fc8f-e053-2995a90aae05
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metformin Hydrochloride
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Denton Pharma, Inc. dba Northwind Pharmaceuticals
- Application
- ANDA206145
- Marketing category
- ANDA
- Marketing start
- 2020-08-03
- Marketing end
- 0000-00-00
- Substance
- METFORMIN HYDROCHLORIDE
- Active strength
- 500 mg/1
- Pharmacologic classes
- Biguanide [EPC],Biguanides [CS]
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 70934-788-30 | 2023-02-01 | C162847 | 48780-1 | f386c649-feba-0266-e053-dadaa90a7c1a | ac9a71b7-c39f-383a-e053-2995a90a7fb4 |
| 70934-788-60 | 2023-02-01 | C162847 | 48780-1 | f386c649-feba-0266-e053-dadaa90a7c1a | ac9a71b7-c39f-383a-e053-2995a90a7fb4 |
| 70934-788-90 | 2023-02-01 | C162847 | 48780-1 | f386c649-feba-0266-e053-dadaa90a7c1a | ac9a71b7-c39f-383a-e053-2995a90a7fb4 |
| 70934-788-98 | 2023-02-01 | C162847 | 48780-1 | f386c649-feba-0266-e053-dadaa90a7c1a | ac9a71b7-c39f-383a-e053-2995a90a7fb4 |
| 70934-788-30 | 2023-01-30 | C162847 | 48780-1 | f386c649-feba-0266-e053-dadaa90a7c1a | ac9a71b7-c39f-383a-e053-2995a90a7fb4 |
| 70934-788-60 | 2023-01-30 | C162847 | 48780-1 | f386c649-feba-0266-e053-dadaa90a7c1a | ac9a71b7-c39f-383a-e053-2995a90a7fb4 |
| 70934-788-90 | 2023-01-30 | C162847 | 48780-1 | f386c649-feba-0266-e053-dadaa90a7c1a | ac9a71b7-c39f-383a-e053-2995a90a7fb4 |
| 70934-788-98 | 2023-01-30 | C162847 | 48780-1 | f386c649-feba-0266-e053-dadaa90a7c1a | ac9a71b7-c39f-383a-e053-2995a90a7fb4 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 70934-788-30 | EA - Each | 70934-788 | ec9a6d56-df66-4f9f-bee4-fac9e4d03a93 | 1 | 2022-12-07 |
| 70934-788-60 | EA - Each | 70934-788 | 40970de6-015e-4d68-a765-81ff0af0e4f5 | 1 | 2022-12-07 |
| 70934-788-90 | EA - Each | 70934-788 | 50a34ad2-58d1-41da-bc0d-d1da7cf4bdc6 | 1 | 2021-10-08 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 70934-788-30 | 70934078830 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70934-788-30) | 2021-03-22 | 0000-00-00 | No | No | Current |
| 70934-788-60 | 70934078860 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70934-788-60) | 2021-03-22 | 0000-00-00 | No | No | Current |
| 70934-788-90 | 70934078890 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70934-788-90) | 2020-10-05 | 0000-00-00 | No | No | Current |
| 70934-788-98 | 70934078898 | 120 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70934-788-98) | 2020-08-03 | 0000-00-00 | No | No | Current |