Miglitol
- Product NDC
- 76333-125
- 11-digit product format
- 763330125
- Labeler code
- 76333
- Product ID
- 76333-125_9590040d-c6bd-dbf7-e053-2a95a90a834c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Miglitol
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- Orient Pharma Co., Ltd.
- Application
- ANDA203965
- Marketing category
- ANDA
- Marketing start
- 2015-07-31
- Marketing end
- 0000-00-00
- Substance
- MIGLITOL
- Active strength
- 25 mg/1
- Pharmacologic classes
- alpha Glucosidase Inhibitors [MoA],alpha-Glucosidase Inhibitor [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 76333-125-11 | Miglitol | 100 in 1 BOTTLE | TABLET, COATED | 100 | | 7 |
| 76333-125-12 | Miglitol | 1000 in 1 BOTTLE | TABLET, COATED | 1000 | | 7 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Miglitol | ACTIVE INGREDIENT | 0V5436JAQW | MIGLITOL TABLET, COATED [ORIENT PHARMA CO., LTD.] | 5 | |
| Miglitol | ACTIVE MOIETY | 0V5436JAQW | MIGLITOL TABLET, COATED [ORIENT PHARMA CO., LTD.] | 5 | |
| Cellulose, Microcrystalline | INACTIVE INGREDIENT | OP1R32D61U | MIGLITOL TABLET, COATED [ORIENT PHARMA CO., LTD.] | 5 | |
| Hypromelloses | INACTIVE INGREDIENT | 3NXW29V3WO | MIGLITOL TABLET, COATED [ORIENT PHARMA CO., LTD.] | 5 | |
| Magnesium Stearate | INACTIVE INGREDIENT | 70097M6I30 | MIGLITOL TABLET, COATED [ORIENT PHARMA CO., LTD.] | 5 | |
| Polyethylene glycol 400 | INACTIVE INGREDIENT | B697894SGQ | MIGLITOL TABLET, COATED [ORIENT PHARMA CO., LTD.] | 5 | |
| Polysorbate 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | MIGLITOL TABLET, COATED [ORIENT PHARMA CO., LTD.] | 5 | |
| Starch, Corn | INACTIVE INGREDIENT | O8232NY3SJ | MIGLITOL TABLET, COATED [ORIENT PHARMA CO., LTD.] | 5 | |
| Titanium dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | MIGLITOL TABLET, COATED [ORIENT PHARMA CO., LTD.] | 5 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 76333-125 | MIGLITOL TABLET, COATED [ORIENT PHARMA CO., LTD.] | 7 | Legacy NDC, 2 package rows | 20191024_192e6ed7-9e8c-4772-9e3b-5912a1c63a31.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 |
|---|
| 76333-125-11 | 76333012511 | 100 TABLET, COATED in 1 BOTTLE (76333-125-11) | 2019-10-23 | 0000-00-00 | No | No | Current |
| 76333-125-12 | 76333012512 | 1000 TABLET, COATED in 1 BOTTLE (76333-125-12) | 2019-10-23 | 0000-00-00 | No | No | Current |