Metformin HCl
- Product NDC
- 49483-622
- 11-digit product format
- 494830622
- Labeler code
- 49483
- Product ID
- 49483-622_2dc48b61-581f-fe5c-e063-6394a90aa557
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metformin HCl
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- TIME CAP LABORATORIES, INC
- Application
- ANDA090888
- Marketing category
- ANDA
- Marketing start
- 2016-11-14
- Substance
- METFORMIN HYDROCHLORIDE
- Active strength
- 500 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 HCl
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| METFORMIN HYDROCHLORIDE | 500 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 786Z46389E |
| Rxcui | 861004, 861007, 861010 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 49483-622-01 | 2025-02-10 | C162847 | 48780-1 | 2cef2736-80e8-d83d-e063-dadaa90ab31f | These highlights do not include all the information needed to use Metformin Hydrochloride Tablets, USP safely and effectively. See full prescribing information for Metformin Hydrochloride Tablets, USP. Metformin Hydrochloride Tablets, USP for oral use Initial U.S. Approval: 1995 |
| 49483-622-10 | 2025-02-10 | C162847 | 48780-1 | 2cef2736-80e8-d83d-e063-dadaa90ab31f | These highlights do not include all the information needed to use Metformin Hydrochloride Tablets, USP safely and effectively. See full prescribing information for Metformin Hydrochloride Tablets, USP. Metformin Hydrochloride Tablets, USP for oral use Initial U.S. Approval: 1995 |
| 49483-622-50 | 2025-02-10 | C162847 | 48780-1 | 2cef2736-80e8-d83d-e063-dadaa90ab31f | These highlights do not include all the information needed to use Metformin Hydrochloride Tablets, USP safely and effectively. See full prescribing information for Metformin Hydrochloride Tablets, USP. Metformin Hydrochloride Tablets, USP for oral use Initial U.S. Approval: 1995 |
| 49483-622-81 | 2025-02-10 | C162847 | 48780-1 | 2cef2736-80e8-d83d-e063-dadaa90ab31f | These highlights do not include all the information needed to use Metformin Hydrochloride Tablets, USP safely and effectively. See full prescribing information for Metformin Hydrochloride Tablets, USP. Metformin Hydrochloride Tablets, USP for oral use Initial U.S. Approval: 1995 |
| 49483-622-01 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-80e8-d83d-e063-dadaa90ab31f | These highlights do not include all the information needed to use Metformin Hydrochloride Tablets, USP safely and effectively. See full prescribing information for Metformin Hydrochloride Tablets, USP. Metformin Hydrochloride Tablets, USP for oral use Initial U.S. Approval: 1995 |
| 49483-622-10 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-80e8-d83d-e063-dadaa90ab31f | These highlights do not include all the information needed to use Metformin Hydrochloride Tablets, USP safely and effectively. See full prescribing information for Metformin Hydrochloride Tablets, USP. Metformin Hydrochloride Tablets, USP for oral use Initial U.S. Approval: 1995 |
| 49483-622-50 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-80e8-d83d-e063-dadaa90ab31f | These highlights do not include all the information needed to use Metformin Hydrochloride Tablets, USP safely and effectively. See full prescribing information for Metformin Hydrochloride Tablets, USP. Metformin Hydrochloride Tablets, USP for oral use Initial U.S. Approval: 1995 |
| 49483-622-81 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-80e8-d83d-e063-dadaa90ab31f | These highlights do not include all the information needed to use Metformin Hydrochloride Tablets, USP safely and effectively. See full prescribing information for Metformin Hydrochloride Tablets, USP. Metformin Hydrochloride Tablets, USP for oral use Initial U.S. Approval: 1995 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 49483-622-01 | Metformin HCl | 100 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 100 | | 6 |
| 49483-622-10 | Metformin HCl | 1000 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 1000 | | 6 |
| 49483-622-50 | Metformin HCl | 500 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 500 | | 6 |
| 49483-622-81 | Metformin HCl | 180 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 180 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 49483-622 | METFORMIN HCL TABLET, FILM COATED [TIME CAP LABORATORIES, INC] | 6 | Current NDC, Legacy NDC, 4 package rows | 20250212_542cec22-eeae-4704-9bb6-4176640e5ea8.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 49483-622-01 | 49483062201 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (49483-622-01) | 2016-11-16 | 0000-00-00 | No | No | Current |
| 49483-622-10 | 49483062210 | 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (49483-622-10) | 2017-06-05 | 0000-00-00 | No | No | Current |
| 49483-622-50 | 49483062250 | 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (49483-622-50) | 2016-11-16 | 0000-00-00 | No | No | Current |
| 49483-622-81 | 49483062281 | 180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (49483-622-81) | 2017-06-05 | 0000-00-00 | No | No | Current |