PENTOXIFYLLINE
- Product NDC
- 0904-5448
- 11-digit product format
- 009045448
- Labeler code
- 0904
- Product ID
- 0904-5448_e41391a6-e956-41ab-8169-45f6e48d4fa2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- PENTOXIFYLLINE
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- Application
- ANDA075191
- Marketing category
- ANDA
- Marketing start
- 1999-06-10
- Substance
- PENTOXIFYLLINE
- Active strength
- 400 mg/1
- Pharmacologic classes
- Blood Viscosity Reducer [EPC], Hematologic Activity Alteration [PE]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- PENTOXIFYLLINE
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PENTOXIFYLLINE | 400 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | SD6QCT3TSU |
| Rxcui | 312301 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0904-5448-61 | PENTOXIFYLLINE | 1 in 1 BLISTER PACK | TABLET, EXTENDED RELEASE | 1 | | 6 |
| 0904-5448-61 | PENTOXIFYLLINE | 100 in 1 CARTON | TABLET, EXTENDED RELEASE | 100 | | 6 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| PENTOXIFYLLINE | ACTIVE INGREDIENT | SD6QCT3TSU | PENTOXIFYLLINE TABLET, EXTENDED RELEASE [MAJOR PHARMACEUTICALS] | 1 | |
| PENTOXIFYLLINE | ACTIVE MOIETY | SD6QCT3TSU | PENTOXIFYLLINE TABLET, EXTENDED RELEASE [MAJOR PHARMACEUTICALS] | 1 | |
| HYDROXYPROPYL CELLULOSE | INACTIVE INGREDIENT | RFW2ET671P | PENTOXIFYLLINE TABLET, EXTENDED RELEASE [MAJOR PHARMACEUTICALS] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | PENTOXIFYLLINE TABLET, EXTENDED RELEASE [MAJOR PHARMACEUTICALS] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | PENTOXIFYLLINE TABLET, EXTENDED RELEASE [MAJOR PHARMACEUTICALS] | 1 | |
| POLYETHYLENE GLYCOL 8000 | INACTIVE INGREDIENT | Q662QK8M3B | PENTOXIFYLLINE TABLET, EXTENDED RELEASE [MAJOR PHARMACEUTICALS] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | PENTOXIFYLLINE TABLET, EXTENDED RELEASE [MAJOR PHARMACEUTICALS] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | PENTOXIFYLLINE TABLET, EXTENDED RELEASE [MAJOR PHARMACEUTICALS] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0904-5448 | PENTOXIFYLLINE TABLET, EXTENDED RELEASE [MAJOR PHARMACEUTICALS] | 5 | Current NDC, Legacy NDC, 2 package rows | 20241030_59c9a583-1f93-480f-879c-457a574374da.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 |
|---|
| 0904-5448-61 | 00904544861 | 100 BLISTER PACK in 1 CARTON (0904-5448-61) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | 100 blister pack | 1999-06-10 | 0000-00-00 | No | No | Current |