Viokace
- Product NDC
- 73562-104
- 11-digit product format
- 735620104
- Labeler code
- 73562
- Product ID
- 73562-104_95ece3e2-a51f-4f4c-81ec-71aa2930a158
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Pancrelipase
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aimmune Therapeutics, Inc.
- Application
- BLA022542
- Marketing category
- BLA
- Marketing start
- 2021-03-01
- Substance
- PANCRELIPASE AMYLASE; PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE
- Active strength
- 39150; 10440; 39150 [USP'U]/1; [USP'U]/1; [USP'U]/1
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Viokace
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PANCRELIPASE AMYLASE | 39150 [USP'U]/1 |
| PANCRELIPASE LIPASE | 10440 [USP'U]/1 |
| PANCRELIPASE PROTEASE | 39150 [USP'U]/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 3560D81V50, 8MYC33932O, YOJ58O116E |
| Rxcui | 1247379, 1247381, 1247386, 1247388 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 73562-104-10 | Viokace | 100 in 1 BOTTLE | TABLET | 100 | | 7 |
| 73562-104-10 | Viokace | 1 in 1 CARTON | TABLET | 1 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 73562-104 | VIOKACE (PANCRELIPASE) TABLET [AIMMUNE THERAPEUTICS, INC] | 4 | Current NDC, Legacy NDC, 2 package rows | 20240315_58bdb8de-582d-44e6-9b72-8d5a42fdf501.zip |
DailyMed RxNorm Mappings#
RxCUI, RxNorm string, TTY table| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|
| 1247386 | lipase 10,400 UNT / amylase 39,150 UNT / protease 39,150 UNT Oral Tablet | PSN | 58bdb8de-582d-44e6-9b72-8d5a42fdf501 | 7 |
| 1247379 | lipase 20,880 UNT / amylase 78,300 UNT / protease 78,300 UNT Oral Tablet | PSN | 58bdb8de-582d-44e6-9b72-8d5a42fdf501 | 7 |
| 1247388 | Viokace 10,440 UNT / 39,150 UNT / 39,150 UNT Oral Tablet | PSN | 58bdb8de-582d-44e6-9b72-8d5a42fdf501 | 7 |
| 1247381 | Viokace 20,880 UNT / 78,300 UNT / 78,300 UNT Oral Tablet | PSN | 58bdb8de-582d-44e6-9b72-8d5a42fdf501 | 7 |
| 1247388 | amylase 39150 UNT / lipase 10440 UNT / protease 39150 UNT Oral Tablet [Viokace] | SBD | 58bdb8de-582d-44e6-9b72-8d5a42fdf501 | 7 |
| 1247381 | amylase 78300 UNT / lipase 20880 UNT / protease 78300 UNT Oral Tablet [Viokace] | SBD | 58bdb8de-582d-44e6-9b72-8d5a42fdf501 | 7 |
| 1247386 | amylase 39150 UNT / lipase 10440 UNT / protease 39150 UNT Oral Tablet | SCD | 58bdb8de-582d-44e6-9b72-8d5a42fdf501 | 7 |
| 1247379 | amylase 78300 UNT / lipase 20880 UNT / protease 78300 UNT Oral Tablet | SCD | 58bdb8de-582d-44e6-9b72-8d5a42fdf501 | 7 |
| 1247386 | amylase 39,150 UNT / lipase 10,440 UNT / protease 39,150 UNT Oral Tablet | SY | 58bdb8de-582d-44e6-9b72-8d5a42fdf501 | 7 |
| 1247379 | amylase 78,300 UNT / lipase 20,880 UNT / protease 78,300 UNT Oral Tablet | SY | 58bdb8de-582d-44e6-9b72-8d5a42fdf501 | 7 |
| 1247386 | amylases 39,150 UNT / endopeptidases 39,150 UNT / lipase 10,440 UNT Oral Tablet | SY | 58bdb8de-582d-44e6-9b72-8d5a42fdf501 | 7 |
| 1247379 | amylases 78,300 UNT / endopeptidases 78,300 UNT / lipase 20,880 UNT Oral Tablet | SY | 58bdb8de-582d-44e6-9b72-8d5a42fdf501 | 7 |
| 1247388 | Viokace 10 (amylase 39,150 UNT / lipase 10,440 UNT / protease 39,150 UNT) Oral Tablet | SY | 58bdb8de-582d-44e6-9b72-8d5a42fdf501 | 7 |
| 1247381 | Viokace 20 (amylase 78,300 UNT / lipase 20,880 UNT / protease 78,300 UNT) Oral Tablet | SY | 58bdb8de-582d-44e6-9b72-8d5a42fdf501 | 7 |
| 1247388 | Viokase 10 Oral Tablet | SY | 58bdb8de-582d-44e6-9b72-8d5a42fdf501 | 7 |
| 1247388 | Viokase 20 (amylases 39,150 UNT / endopeptidases 39,150 UNT / lipase 10,440 UNT) Oral Tablet | SY | 58bdb8de-582d-44e6-9b72-8d5a42fdf501 | 7 |
| 1247381 | Viokase 20 (amylases 78,300 UNT / endopeptidases 78,300 UNT / lipase 20,880 UNT) Oral Tablet | SY | 58bdb8de-582d-44e6-9b72-8d5a42fdf501 | 7 |
| 1247381 | Viokase 20 Oral Tablet | SY | 58bdb8de-582d-44e6-9b72-8d5a42fdf501 | 7 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 73562-104-10 | 73562010410 | 1 BOTTLE in 1 CARTON (73562-104-10) / 100 TABLET in 1 BOTTLE | 1 bottle | 2021-03-01 | 0000-00-00 | No | No | Current |