Metformin Hydrochloride
- Product NDC
- 70518-0512
- 11-digit product format
- 705180512
- Labeler code
- 70518
- Product ID
- 70518-0512_ebde6ef6-eac0-a800-e053-2a95a90aa40b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metformin Hydrochloride
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA078321
- Marketing category
- ANDA
- Marketing start
- 2017-05-09
- 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
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70518-0512 | METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [REMEDYREPACK INC.] | 15 | Legacy NDC | 20250112_c3502555-ef47-4a00-8a4f-98c83e158012.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 70518-0512-0 | 70518051200 | 30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (70518-0512-0) | | 2017-05-09 | 0000-00-00 | No | No | Current |
| 70518-0512-1 | 70518051201 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70518-0512-1) | | 2019-06-20 | 0000-00-00 | No | No | Current |
| 70518-0512-2 | 70518051202 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70518-0512-2) | | 2019-09-23 | 0000-00-00 | No | No | Current |
| 70518-0512-3 | 70518051203 | 100 POUCH in 1 BOX (70518-0512-3) > 1 TABLET, EXTENDED RELEASE in 1 POUCH (70518-0512-4) | 100 pouch | 2020-10-12 | 0000-00-00 | No | No | Current |