Acarbose
- Product NDC
- 0054-0140
- 11-digit product format
- 000540140
- Labeler code
- 0054
- Product ID
- 0054-0140_2d7f6918-65c3-4db3-b775-b74e1e637cea
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Acarbose
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- ANDA078470
- Marketing category
- ANDA
- Marketing start
- 2008-05-07
- Substance
- ACARBOSE
- Active strength
- 25 mg/1
- Pharmacologic classes
- alpha Glucosidase Inhibitors [MoA], alpha-Glucosidase Inhibitor [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Acarbose
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ACARBOSE | 25 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | T58MSI464G |
| Rxcui | 199149, 199150, 200132 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0054-0140-25 | Acarbose | 100 in 1 BOTTLE | TABLET | 100 | | 11 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ACARBOSE | ACTIVE INGREDIENT | T58MSI464G | ACARBOSE TABLET [ROXANE LABORATORIES, INC] | 6 | |
| ACARBOSE | ACTIVE MOIETY | T58MSI464G | ACARBOSE TABLET [ROXANE LABORATORIES, INC] | 6 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | ACARBOSE TABLET [ROXANE LABORATORIES, INC] | 6 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | ACARBOSE TABLET [ROXANE LABORATORIES, INC] | 6 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | ACARBOSE TABLET [ROXANE LABORATORIES, INC] | 6 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | ACARBOSE TABLET [ROXANE LABORATORIES, INC] | 6 | |
| ACARBOSE | ACTIVE INGREDIENT | T58MSI464G | ACARBOSE TABLET [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| ACARBOSE | ACTIVE MOIETY | T58MSI464G | ACARBOSE TABLET [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | ACARBOSE TABLET [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | ACARBOSE TABLET [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | ACARBOSE TABLET [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | ACARBOSE TABLET [PHYSICIANS TOTAL CARE, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0054-0140 | ACARBOSE TABLET [HIKMA PHARMACEUTICALS USA INC.] | 11 | Current NDC, Legacy NDC, 1 package rows | 20240724_352dd336-d3f9-4ac5-a000-91d3aef7aca3.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 |
|---|
| 0054-0140-25 | 00054014025 | 100 TABLET in 1 BOTTLE (0054-0140-25) | 100 tablet | 2008-05-07 | 0000-00-00 | No | No | Current |