Metformin Hydrochloride
- Product NDC
- 67877-414
- 11-digit product format
- 678770414
- Labeler code
- 67877
- Product ID
- 67877-414_4fa6bd66-7f2c-4b63-9809-be460cbc2527
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metformin Hydrochloride
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Ascend Laboratories, LLC
- Application
- ANDA206145
- Marketing category
- ANDA
- Marketing start
- 2018-10-27
- Substance
- METFORMIN HYDROCHLORIDE
- Active strength
- 750 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 | 750 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 |
|---|
| 67877-414-01 | Metformin Hydrochloride | 100 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 100 | | 24 |
| 67877-414-05 | Metformin Hydrochloride | 500 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 500 | | 24 |
| 67877-414-10 | Metformin Hydrochloride | 1000 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 1000 | | 24 |
| 67877-414-33 | Metformin Hydrochloride | 10 in 1 CARTON | TABLET, EXTENDED RELEASE | 10 | | 24 |
| 67877-414-33 | Metformin Hydrochloride | 10 in 1 BLISTER PACK | TABLET, EXTENDED RELEASE | 10 | | 24 |
| 67877-414-90 | Metformin Hydrochloride | 90 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 90 | | 24 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| METFORMIN HYDROCHLORIDE | ACTIVE INGREDIENT | 786Z46389E | METFORMIN HYDROCHLORIDE TABLET, FILM COATED [ASCEND LABORATORIES, LLC] | 11 | |
| METFORMIN | ACTIVE MOIETY | 9100L32L2N | METFORMIN HYDROCHLORIDE TABLET, FILM COATED [ASCEND LABORATORIES, LLC] | 11 | |
| HYPROMELLOSE 2910 (15 MPA.S) | INACTIVE INGREDIENT | 36SFW2JZ0W | METFORMIN HYDROCHLORIDE TABLET, FILM COATED [ASCEND LABORATORIES, LLC] | 11 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | METFORMIN HYDROCHLORIDE TABLET, FILM COATED [ASCEND LABORATORIES, LLC] | 11 | |
| POLYETHYLENE GLYCOL 6000 | INACTIVE INGREDIENT | 30IQX730WE | METFORMIN HYDROCHLORIDE TABLET, FILM COATED [ASCEND LABORATORIES, LLC] | 11 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | METFORMIN HYDROCHLORIDE TABLET, FILM COATED [ASCEND LABORATORIES, LLC] | 11 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | METFORMIN HYDROCHLORIDE TABLET, FILM COATED [ASCEND LABORATORIES, LLC] | 11 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | METFORMIN HYDROCHLORIDE TABLET, FILM COATED [ASCEND LABORATORIES, LLC] | 11 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | METFORMIN HYDROCHLORIDE TABLET, FILM COATED [ASCEND LABORATORIES, LLC] | 11 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | METFORMIN HYDROCHLORIDE TABLET, FILM COATED [ASCEND LABORATORIES, LLC] | 11 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 67877-414 | METFORMIN HYDROCHLORIDE TABLET, FILM COATED METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [ASCEND LABORATORIES, LLC] | 23 | Current NDC, Legacy NDC, 6 package rows | 20231101_0ff1ba75-3c86-4baf-a6b1-1bb883839866.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 67877-414-01 | 67877041401 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (67877-414-01) | | 2018-10-27 | 0000-00-00 | No | No | Current |
| 67877-414-05 | 67877041405 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (67877-414-05) | | 2018-10-27 | 0000-00-00 | No | No | Current |
| 67877-414-10 | 67877041410 | 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (67877-414-10) | | 2018-10-27 | 0000-00-00 | No | No | Current |
| 67877-414-33 | 67877041433 | 10 BLISTER PACK in 1 CARTON (67877-414-33) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | 10 blister pack | 2018-10-27 | 0000-00-00 | No | No | Current |
| 67877-414-90 | 67877041490 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (67877-414-90) | | 2019-12-27 | 0000-00-00 | No | No | Current |