Flucytosine
- Product NDC
- 42385-983
- 11-digit product format
- 423850983
- Labeler code
- 42385
- Product ID
- 42385-983_2aaf23f5-9b8f-4c5a-8c90-5c83765ad889
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Flucytosine
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Laurus Labs Limited
- Application
- ANDA218005
- Marketing category
- ANDA
- Marketing start
- 2025-07-24
- Substance
- FLUCYTOSINE
- Active strength
- 250 mg/1
- Pharmacologic classes
- Nucleoside Analog Antifungal [EPC], Nucleoside Analog [EXT]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Flucytosine
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| FLUCYTOSINE | 250 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | D83282DT06 |
| Rxcui | 197702, 197703 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 42385-983-01 | Flucytosine | 100 in 1 BOTTLE | CAPSULE | 100 | | 1 |
| 42385-983-27 | Flucytosine | 10 in 1 BLISTER PACK | CAPSULE | 10 | | 1 |
| 42385-983-27 | Flucytosine | 10 in 1 CARTON | CAPSULE | 10 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 42385-983-01 | 42385098301 | 100 CAPSULE in 1 BOTTLE (42385-983-01) | 100 capsule | 2025-07-24 | No | No | Historical |
| 42385-983-27 | 42385098327 | 10 BLISTER PACK in 1 CARTON (42385-983-27) / 10 CAPSULE in 1 BLISTER PACK | 10 blister pack | 2025-07-24 | No | No | Historical |