Darunavir
- Product NDC
- 72205-185
- 11-digit product format
- 722050185
- Labeler code
- 72205
- Product ID
- 72205-185_ea6e0136-75b2-4793-9500-04e6658a0a73
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Darunavir
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Novadoz Pharmaceuticals LLC
- Application
- ANDA215389
- Marketing category
- ANDA
- Marketing start
- 2023-11-28
- Substance
- DARUNAVIR
- Active strength
- 800 mg/1
- Pharmacologic classes
- Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], HIV Protease Inhibitors [MoA], Protease Inhibitor [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 81157882-d7f5-4b49-9a52-b2a0c7e54020 | Product name | 2 | 20260107 |
| 12fd8c59-0b3a-2882-9cdb-92782ec03e2f | Product name | 6 | 20251113 |
| 362d7abb-94e6-4c60-9a58-266894157713 | Product name | 1 | 20231023 |
| 816b97af-edc5-4060-aff1-b814bdbcad50 | Product name | 1 | 20190415 |
| a56d673d-fa42-4b0e-b5ce-e65a5eab34b7 | Product name | 1 | 20180911 |
| 419aab54-5d5a-4146-9453-026d4a9991be | Product name | 2 | 20170525 |
| 89dac932-b90a-4410-9ab1-84c53e57de25 | Product name | 1 | 20150316 |
| d723478e-ad4a-ec23-6bd7-cfe33e1e3840 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 72205-185-30 | Darunavir | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 30 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 72205-185-30 | EA - Each | 72205-185 | 625044f3-2abf-4abd-aa43-5bd4ca1169a4 | 1 | 2023-12-05 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1359269 | darunavir 800 MG Oral Tablet | PSN | e80e44f8-1987-4b78-a63d-a4e4d5122ddb | 100 |
| 1359269 | darunavir 800 MG Oral Tablet | SCD | e80e44f8-1987-4b78-a63d-a4e4d5122ddb | 100 |
| 1359269 | darunavir (as darunavir ethanolate) 800 MG Oral Tablet | SY | e80e44f8-1987-4b78-a63d-a4e4d5122ddb | 100 |
| 670026 | darunavir 600 MG Oral Tablet | PSN | ea6e0136-75b2-4793-9500-04e6658a0a73 | 1 |
| 1359269 | darunavir 800 MG Oral Tablet | PSN | ea6e0136-75b2-4793-9500-04e6658a0a73 | 1 |
| 670026 | darunavir 600 MG Oral Tablet | SCD | ea6e0136-75b2-4793-9500-04e6658a0a73 | 1 |
| 1359269 | darunavir 800 MG Oral Tablet | SCD | ea6e0136-75b2-4793-9500-04e6658a0a73 | 1 |
| 670026 | darunavir (as darunavir ethanolate) 600 MG Oral Tablet | SY | ea6e0136-75b2-4793-9500-04e6658a0a73 | 1 |
| 1359269 | darunavir (as darunavir ethanolate) 800 MG Oral Tablet | SY | ea6e0136-75b2-4793-9500-04e6658a0a73 | 1 |
| 670026 | darunavir (as darunavir hydrate) 600 MG Oral Tablet | SY | ea6e0136-75b2-4793-9500-04e6658a0a73 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 72205-185-30 | 72205018530 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72205-185-30) | 2023-11-29 | No | No | Historical |