Cilostazol
- Product NDC
- 0054-0044
- 11-digit product format
- 000540044
- Labeler code
- 0054
- Product ID
- 0054-0044_d872300b-ff60-4709-a667-aab53462bfac
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cilostazol
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- West-Ward Pharmaceuticals Corp.
- Application
- ANDA077024
- Marketing category
- ANDA
- Marketing start
- 2005-05-17
- Marketing end
- 0000-00-00
- Substance
- CILOSTAZOL
- Active strength
- 100 mg/1
- Pharmacologic classes
- Phosphodiesterase 3 Inhibitor [EPC], Phosphodiesterase 3 Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| c114def4-591e-cde9-1a9f-29af28d4c1ea | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 0054-0044-21 | 2022-08-05 | C162847 | 48780-1 | e4f33bdf-a8c0-d8a0-e053-dadaa90a6e4e | 9ffdb1e8-fdc8-44d4-b558-210954138b2f |
| 0054-0044-29 | 2022-08-05 | C162847 | 48780-1 | e4f33bdf-a8c0-d8a0-e053-dadaa90a6e4e | 9ffdb1e8-fdc8-44d4-b558-210954138b2f |
| 0054-0044-21 | 2022-07-29 | C162847 | 48780-1 | e4f33bdf-a8c0-d8a0-e053-dadaa90a6e4e | 9ffdb1e8-fdc8-44d4-b558-210954138b2f |
| 0054-0044-29 | 2022-07-29 | C162847 | 48780-1 | e4f33bdf-a8c0-d8a0-e053-dadaa90a6e4e | 9ffdb1e8-fdc8-44d4-b558-210954138b2f |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0054-0044-21 | EA - Each | 0054-0044 | 07a314f3-f5a7-4730-b33b-574f4b31581c | 1 | 2012-07-24 |
| 0054-0044-29 | EA - Each | 0054-0044 | 7c21aeb0-3e8b-49ec-b8bc-ccfd2cc3239c | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| CILOSTAZOL | ACTIVE INGREDIENT | N7Z035406B | CILOSTAZOL TABLET [CARILION MATERIALS MANAGEMENT] | 2 | |
| CILOSTAZOL | ACTIVE MOIETY | N7Z035406B | CILOSTAZOL TABLET [CARILION MATERIALS MANAGEMENT] | 2 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | CILOSTAZOL TABLET [CARILION MATERIALS MANAGEMENT] | 2 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | CILOSTAZOL TABLET [CARILION MATERIALS MANAGEMENT] | 2 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | CILOSTAZOL TABLET [CARILION MATERIALS MANAGEMENT] | 2 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | CILOSTAZOL TABLET [CARILION MATERIALS MANAGEMENT] | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | CILOSTAZOL TABLET [CARILION MATERIALS MANAGEMENT] | 2 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | CILOSTAZOL TABLET [CARILION MATERIALS MANAGEMENT] | 2 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 242461 | cilostazol 100 MG Oral Tablet | PSN | 50fc64ac-7eb3-4bab-8de2-83cd5404d169 | 3 |
| 242461 | cilostazol 100 MG Oral Tablet | SCD | 50fc64ac-7eb3-4bab-8de2-83cd5404d169 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0054-0044-21 | 00054004421 | 60 TABLET in 1 BOTTLE (0054-0044-21) | 60 tablet | 2005-05-17 | 0000-00-00 | No | No | Current |
| 0054-0044-29 | 00054004429 | 500 TABLET in 1 BOTTLE (0054-0044-29) | 500 tablet | 2005-05-17 | 0000-00-00 | No | No | Current |