DRIZALMA SPRINKLE
- Product NDC
- 47335-617
- 11-digit product format
- 473350617
- Labeler code
- 47335
- Product ID
- 47335-617_67134e3c-1819-4262-a36f-460afdbb165d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Duloxetine
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- SUN PHARMACEUTICAL INDUSTRIES, INC.
- Application
- NDA212516
- Marketing category
- NDA
- Marketing start
- 2024-06-10
- Substance
- DULOXETINE HYDROCHLORIDE
- Active strength
- 30 mg/1
- Pharmacologic classes
- Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake 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
- DRIZALMA SPRINKLE
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DULOXETINE HYDROCHLORIDE | 30 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 9044SC542W |
| Rxcui | 2200168, 2200174, 2200175, 2200177, 2200178, 2200180, 2200181, 2200183 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| aebfdb62-b550-4c4f-9225-d5d3bbc7ab88 | Product name | 9 | 20210727 |
| 7dd29e28-6b69-499b-9257-12a3b46ca283 | Product name | 1 | 20191120 |
| c5cd4727-ac49-4409-82b1-5bd8006c3ec7 | Product name | 1 | 20171122 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 47335-617-10 | DRIZALMA SPRINKLE | 1000 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 1000 | 6 | |
| 47335-617-30 | DRIZALMA SPRINKLE | 30 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 30 | 6 | |
| 47335-617-60 | DRIZALMA SPRINKLE | 60 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 60 | 6 | |
| 47335-617-90 | DRIZALMA SPRINKLE | 90 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 90 | 6 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2200174 | DRIZALMA 20 MG Delayed Release Oral Capsule | PSN | b41423b8-dfec-4d79-ba3c-e43a87803d85 | 6 |
| 2200177 | DRIZALMA 30 MG Delayed Release Oral Capsule | PSN | b41423b8-dfec-4d79-ba3c-e43a87803d85 | 6 |
| 2200180 | Drizalma 40 MG Delayed Release Oral Capsule | PSN | b41423b8-dfec-4d79-ba3c-e43a87803d85 | 6 |
| 2200183 | Drizalma 60 MG Delayed Release Oral Capsule | PSN | b41423b8-dfec-4d79-ba3c-e43a87803d85 | 6 |
| 2200168 | DULoxetine 20 MG Sprinkle Delayed Release Oral Capsule | PSN | b41423b8-dfec-4d79-ba3c-e43a87803d85 | 6 |
| 2200175 | DULoxetine 30 MG Sprinkle Delayed Release Oral Capsule | PSN | b41423b8-dfec-4d79-ba3c-e43a87803d85 | 6 |
| 2200178 | DULoxetine 40 MG Sprinkle Delayed Release Oral Capsule | PSN | b41423b8-dfec-4d79-ba3c-e43a87803d85 | 6 |
| 2200181 | DULoxetine 60 MG Sprinkle Delayed Release Oral Capsule | PSN | b41423b8-dfec-4d79-ba3c-e43a87803d85 | 6 |
| 2200174 | Sprinkle duloxetine 20 MG Delayed Release Oral Capsule [Drizalma] | SBD | b41423b8-dfec-4d79-ba3c-e43a87803d85 | 6 |
| 2200177 | Sprinkle duloxetine 30 MG Delayed Release Oral Capsule [Drizalma] | SBD | b41423b8-dfec-4d79-ba3c-e43a87803d85 | 6 |
| 2200180 | Sprinkle duloxetine 40 MG Delayed Release Oral Capsule [Drizalma] | SBD | b41423b8-dfec-4d79-ba3c-e43a87803d85 | 6 |
| 2200183 | Sprinkle duloxetine 60 MG Delayed Release Oral Capsule [Drizalma] | SBD | b41423b8-dfec-4d79-ba3c-e43a87803d85 | 6 |
| 2200168 | Sprinkle duloxetine 20 MG Delayed Release Oral Capsule | SCD | b41423b8-dfec-4d79-ba3c-e43a87803d85 | 6 |
| 2200175 | Sprinkle duloxetine 30 MG Delayed Release Oral Capsule | SCD | b41423b8-dfec-4d79-ba3c-e43a87803d85 | 6 |
| 2200178 | Sprinkle duloxetine 40 MG Delayed Release Oral Capsule | SCD | b41423b8-dfec-4d79-ba3c-e43a87803d85 | 6 |
| 2200181 | Sprinkle duloxetine 60 MG Delayed Release Oral Capsule | SCD | b41423b8-dfec-4d79-ba3c-e43a87803d85 | 6 |
| 2200174 | Drizalma 20 MG Delayed Release Oral Capsule | SY | b41423b8-dfec-4d79-ba3c-e43a87803d85 | 6 |
| 2200177 | Drizalma 30 MG Delayed Release Oral Capsule | SY | b41423b8-dfec-4d79-ba3c-e43a87803d85 | 6 |
| 2200180 | Drizalma 40 MG Delayed Release Oral Capsule | SY | b41423b8-dfec-4d79-ba3c-e43a87803d85 | 6 |
| 2200183 | Drizalma 60 MG Delayed Release Oral Capsule | SY | b41423b8-dfec-4d79-ba3c-e43a87803d85 | 6 |
| 2200168 | duloxetine 20 MG Sprinkle (as duloxetine HCl 22.4 MG) Delayed Release Oral Capsule | SY | b41423b8-dfec-4d79-ba3c-e43a87803d85 | 6 |
| 2200175 | duloxetine 30 MG Sprinkle (as duloxetine HCl 33.6 MG) Delayed Release Oral Capsule | SY | b41423b8-dfec-4d79-ba3c-e43a87803d85 | 6 |
| 2200178 | duloxetine 40 MG Sprinkle (as duloxetine HCl 44.9 MG) Delayed Release Oral Capsule | SY | b41423b8-dfec-4d79-ba3c-e43a87803d85 | 6 |
| 2200181 | duloxetine 60 MG Sprinkle (as duloxetine HCl 67.3 MG) Delayed Release Oral Capsule | SY | b41423b8-dfec-4d79-ba3c-e43a87803d85 | 6 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 47335-617-10 | 47335061710 | 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (47335-617-10) | 2024-06-10 | 0000-00-00 | No | No | Current |
| 47335-617-30 | 47335061730 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (47335-617-30) | 2024-06-10 | 0000-00-00 | No | No | Current |
| 47335-617-60 | 47335061760 | 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (47335-617-60) | 2024-06-10 | 0000-00-00 | No | No | Current |
| 47335-617-90 | 47335061790 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (47335-617-90) | 2024-06-10 | 0000-00-00 | No | No | Current |