METFORMIN HYDROCHLORIDE
- Product NDC
- 21695-472
- 11-digit product format
- 216950472
- Labeler code
- 21695
- Product ID
- 21695-472_495738b9-2511-446b-833c-164c0119035b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- METFORMIN HYDROCHLORIDE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Rebel Distributors Corp.
- Application
- ANDA075967
- Marketing category
- ANDA
- Marketing start
- 2002-01-29
- 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 |
|---|---|---|---|---|---|
| 21695-472-30 | 2019-09-24 | C162847 | 48780-1 | 934fe258-4a01-48b1-e053-8cdaa90a720a | METFORMIN HYDROCHLORIDE |
| 21695-472-60 | 2019-09-24 | C162847 | 48780-1 | 934fe258-4a01-48b1-e053-8cdaa90a720a | METFORMIN HYDROCHLORIDE |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 21695-472-30 | METFORMIN HYDROCHLORIDE | 30 in 1 BOTTLE | TABLET | 30 | 1 | |
| 21695-472-60 | METFORMIN HYDROCHLORIDE | 60 in 1 BOTTLE | TABLET | 60 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 21695-472-30 | EA - Each | 21695-472 | 5ce80d4d-c7c7-4578-94cf-d932ddfc9328 | 1 | 2012-07-24 |
| 21695-472-60 | EA - Each | 21695-472 | d90991c4-8810-4107-802b-9790b6788db6 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| METFORMIN HYDROCHLORIDE | ACTIVE INGREDIENT | 786Z46389E | METFORMIN HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP.] | 1 | |
| METFORMIN | ACTIVE MOIETY | 9100L32L2N | METFORMIN HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP.] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | METFORMIN HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP.] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | METFORMIN HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP.] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | METFORMIN HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP.] | 1 | |
| POLYETHYLENE GLYCOL | INACTIVE INGREDIENT | 3WJQ0SDW1A | METFORMIN HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP.] | 1 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | METFORMIN HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP.] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | METFORMIN HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP.] | 1 | |
| TRIACETIN | INACTIVE INGREDIENT | XHX3C3X673 | METFORMIN HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP.] | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 861004 | metFORMIN HCl 1000 MG Oral Tablet | PSN | 495738b9-2511-446b-833c-164c0119035b | 1 |
| 861007 | metFORMIN HCl 500 MG Oral Tablet | PSN | 495738b9-2511-446b-833c-164c0119035b | 1 |
| 861010 | metFORMIN HCl 850 MG Oral Tablet | PSN | 495738b9-2511-446b-833c-164c0119035b | 1 |
| 861004 | metformin hydrochloride 1000 MG Oral Tablet | SCD | 495738b9-2511-446b-833c-164c0119035b | 1 |
| 861007 | metformin hydrochloride 500 MG Oral Tablet | SCD | 495738b9-2511-446b-833c-164c0119035b | 1 |
| 861010 | metformin hydrochloride 850 MG Oral Tablet | SCD | 495738b9-2511-446b-833c-164c0119035b | 1 |
| 861004 | metformin HCl 1 GM Oral Tablet | SY | 495738b9-2511-446b-833c-164c0119035b | 1 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 21695-472-30 | 21695047230 | 30 in 1 BOTTLE | Historical |
| 21695-472-60 | 21695047260 | 60 in 1 BOTTLE | Historical |