Emtricitabine
- Product NDC
- 65862-301
- 11-digit product format
- 658620301
- Labeler code
- 65862
- Product ID
- 65862-301_b4553ee9-214c-43d5-b704-16f4eee5f2b6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Emtricitabine
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA079188
- Marketing category
- ANDA
- Marketing start
- 2023-03-15
- Substance
- EMTRICITABINE
- Active strength
- 200 mg/1
- Pharmacologic classes
- Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleosides [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| G70B4ETF4S | EMTRICITABINE | 143491-57-0 | EMTRICITABINE |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 65862-301-05 | 65862030105 | 500 CAPSULE in 1 BOTTLE (65862-301-05) | 500 capsule | 2023-03-15 | No | No | Historical |
| 65862-301-30 | 65862030130 | 30 CAPSULE in 1 BOTTLE (65862-301-30) | 30 capsule | 2023-03-15 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Emtricitabine | Aurobindo Pharma Limited | 2024-02-07 | Human Prescription Drug Label | 2 |