Metformin Hydrochloride
- Product NDC
- 65162-174
- 11-digit product format
- 651620174
- Labeler code
- 65162
- Product ID
- 65162-174_6fc4d215-86ac-416e-8e9a-5f84b78ef2db
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metformin
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals
- Application
- ANDA077880
- Marketing category
- ANDA
- Marketing start
- 2009-06-01
- Marketing end
- 0000-00-00
- Substance
- METFORMIN HYDROCHLORIDE
- Active strength
- 850 mg/1
- Pharmacologic classes
- Biguanide [EPC],Biguanides [CS]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 65162-174-10 | 2021-01-29 | C162847 | 48780-1 | 97449f38-c24b-f6ea-e053-dbdaa90aa703 | Metformin Hydrochloride Tablets, USP |
| 65162-174-11 | 2021-01-29 | C162847 | 48780-1 | 97449f38-c24b-f6ea-e053-dbdaa90aa703 | Metformin Hydrochloride Tablets, USP |
| 65162-174-50 | 2021-01-29 | C162847 | 48780-1 | 97449f38-c24b-f6ea-e053-dbdaa90aa703 | Metformin Hydrochloride Tablets, USP |
| 65162-174-10 | 2019-11-13 | C162847 | 48780-1 | 97449f38-c24b-f6ea-e053-dbdaa90aa703 | Metformin Hydrochloride Tablets, USP |
| 65162-174-11 | 2019-11-13 | C162847 | 48780-1 | 97449f38-c24b-f6ea-e053-dbdaa90aa703 | Metformin Hydrochloride Tablets, USP |
| 65162-174-50 | 2019-11-13 | C162847 | 48780-1 | 97449f38-c24b-f6ea-e053-dbdaa90aa703 | Metformin Hydrochloride Tablets, USP |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 65162-174-10 | Metformin Hydrochloride | 100 in 1 BOTTLE | TABLET | 100 | 9 | |
| 65162-174-11 | Metformin Hydrochloride | 1000 in 1 BOTTLE | TABLET | 1000 | 9 | |
| 65162-174-50 | Metformin Hydrochloride | 500 in 1 BOTTLE | TABLET | 500 | 9 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 65162-174-10 | EA - Each | 65162-174 | 526c775a-23f0-4378-8184-e6267da1ad4c | 1 | 2013-02-13 |
| 65162-174-11 | EA - Each | 65162-174 | c05ab81d-a7d4-48ba-9c4f-2be987abaa18 | 1 | 2013-02-13 |
| 65162-174-50 | EA - Each | 65162-174 | ddbd2eac-de61-4146-813d-77a208724b19 | 1 | 2013-02-13 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| METFORMIN HYDROCHLORIDE | ACTIVE INGREDIENT | 786Z46389E | METFORMIN HYDROCHLORIDE (METFORMIN) TABLET [AMNEAL PHARMACEUTICALS] | 9 | |
| METFORMIN | ACTIVE MOIETY | 9100L32L2N | METFORMIN HYDROCHLORIDE (METFORMIN) TABLET [AMNEAL PHARMACEUTICALS] | 9 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 861004 | metFORMIN HCl 1000 MG Oral Tablet | PSN | 45cc673a-e125-4d76-8013-89a089eb0ae9 | 9 |
| 861007 | metFORMIN HCl 500 MG Oral Tablet | PSN | 45cc673a-e125-4d76-8013-89a089eb0ae9 | 9 |
| 861010 | metFORMIN HCl 850 MG Oral Tablet | PSN | 45cc673a-e125-4d76-8013-89a089eb0ae9 | 9 |
| 861004 | metformin hydrochloride 1000 MG Oral Tablet | SCD | 45cc673a-e125-4d76-8013-89a089eb0ae9 | 9 |
| 861007 | metformin hydrochloride 500 MG Oral Tablet | SCD | 45cc673a-e125-4d76-8013-89a089eb0ae9 | 9 |
| 861010 | metformin hydrochloride 850 MG Oral Tablet | SCD | 45cc673a-e125-4d76-8013-89a089eb0ae9 | 9 |
| 861004 | metformin HCl 1 GM Oral Tablet | SY | 45cc673a-e125-4d76-8013-89a089eb0ae9 | 9 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 65162-174-10 | 65162017410 | 100 in 1 BOTTLE | Historical |
| 65162-174-11 | 65162017411 | 1000 in 1 BOTTLE | Historical |
| 65162-174-50 | 65162017450 | 500 in 1 BOTTLE | Historical |