Prescription drug · NDA
Emtriva (Emtricitabine) NDC 61958-0601
Emtricitabine 200 mg/1 · Capsule · Oral · Gilead Sciences, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 61958-0601-1 | 6195806010161958060101 | 30 CAPSULE in 1 BOTTLE, PLASTIC (61958-0601-1)Marketed from Jul 2, 2003 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Emtriva
- Generic name (nonproprietary)
- emtricitabine
- Active ingredients
- Emtricitabine — 200 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Gilead Sciences, Inc.NDC labeler code 61958
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021500
- Marketing start
- Listing expires
- Other FDA classes
- Nucleoside Reverse Transcriptase Inhibitors (Mechanism)Nucleosides (Chemical structure)
- Identifiers
- Product ID 61958-0601_13ed3577-67a4-4828-b886-f35206f149a6SPL ID 13ed3577-67a4-4828-b886-f35206f149a6SPL set ID d6599395-3944-44f9-97f2-e0424c6b6a1fRxCUI 403875, 404587, 597291, 616148UNII G70B4ETF4S
- Pharmacologic class
- Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N461958060101followed by a unit qualifier and the quantityPackage 61958-0601-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
EMTRIVA ® is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. EMTRIVA, a nucleoside analog HIV-1 reverse transcriptase inhibitor, is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 61958-0601
- What is NDC 61958-0601?
- 61958-0601 is the product NDC for Emtriva (emtricitabine), Emtricitabine 200 mg/1 capsule, listed with the FDA by Gilead Sciences, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Emtriva (Emtricitabine).
- What is the active ingredient?
- Emtricitabine.
- Who is the labeler?
- Gilead Sciences, Inc., NDC labeler code 61958. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Emtriva?
- 1 other product NDC are listed under this name. See all Emtriva NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Emtriva products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Emtrivaemtricitabine | Emtricitabine 10 mg/mL | SolutionOral | Gilead Sciences, Inc. | 61958-0602 | 61958-0602-01 |