METFORMIN HYDROCHLORIDE
- Product NDC
- 75834-500
- 11-digit product format
- 758340500
- Labeler code
- 75834
- Product ID
- 75834-500_a85b9b37-34f0-4a0d-e053-2995a90ab1ce
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- metformin hydrochloride
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Nivagen Pharmaceuticals Inc
- Application
- ANDA201991
- Marketing category
- ANDA
- Marketing start
- 2013-11-01
- 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
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 75834-500-01 | 2020-06-19 | C162847 | 48780-1 | 9855e2a2-4eea-60a7-e053-dbdaa90a05bd | d01b63e6-70e5-4679-b377-1e0fb78a87b5 |
| 75834-500-05 | 2020-06-19 | C162847 | 48780-1 | 9855e2a2-4eea-60a7-e053-dbdaa90a05bd | d01b63e6-70e5-4679-b377-1e0fb78a87b5 |
| 75834-500-10 | 2020-06-19 | C162847 | 48780-1 | 9855e2a2-4eea-60a7-e053-dbdaa90a05bd | d01b63e6-70e5-4679-b377-1e0fb78a87b5 |
| 75834-500-01 | 2019-11-27 | C162847 | 48780-1 | 9855e2a2-4eea-60a7-e053-dbdaa90a05bd | d01b63e6-70e5-4679-b377-1e0fb78a87b5 |
| 75834-500-05 | 2019-11-27 | C162847 | 48780-1 | 9855e2a2-4eea-60a7-e053-dbdaa90a05bd | d01b63e6-70e5-4679-b377-1e0fb78a87b5 |
| 75834-500-10 | 2019-11-27 | C162847 | 48780-1 | 9855e2a2-4eea-60a7-e053-dbdaa90a05bd | d01b63e6-70e5-4679-b377-1e0fb78a87b5 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 75834-500-01 | EA - Each | 75834-500 | 180deecf-1870-46fa-ba76-7d96bc744e6f | 1 | 2020-08-06 |
| 75834-500-05 | EA - Each | 75834-500 | e5bca3a5-2146-4ebf-b473-580e1cae9714 | 1 | 2020-08-06 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 860975 | metFORMIN HCl 500 MG 24HR Extended Release Oral Tablet | PSN | d738aacf-b2aa-7846-e053-2995a90a1617 | 1 |
| 860975 | 24 HR metformin hydrochloride 500 MG Extended Release Oral Tablet | SCD | d738aacf-b2aa-7846-e053-2995a90a1617 | 1 |
| 860975 | metformin HCl 500 MG 24 HR Extended Release Oral Tablet | SY | d738aacf-b2aa-7846-e053-2995a90a1617 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 75834-500-01 | 75834050001 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (75834-500-01) | 2020-06-16 | 0000-00-00 | No | No | Current |
| 75834-500-05 | 75834050005 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (75834-500-05) | 2020-06-16 | 0000-00-00 | No | No | Current |