Prescription drug · NDA
Solosec (Secnidazole) NDC 69751-400
Secnidazole 2 g/4.8g · Granule · Oral · Evofem Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69751-400-01 | 69751040001 | 1 PACKET in 1 CARTON (69751-400-01) / 2 g in 1 PACKETMarketed from May 31, 2018 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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)
- Solosec
- Generic name (nonproprietary)
- secnidazole
- Active ingredients
- Secnidazole — 2 g/4.8g
- Dosage form
- Granule
- Route
- Oral
- Labeler
- Evofem Inc.NDC labeler code 69751
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 209363
- Marketing start
- Listing expires
- Other FDA classes
- Nitroimidazoles (Chemical structure)
- Identifiers
- Product ID 69751-400_4a3aa8e8-bb23-46ce-998d-69dc7c9fb386SPL ID 4a3aa8e8-bb23-46ce-998d-69dc7c9fb386SPL set ID 056485b6-8bba-4a21-ae00-cdb4e7ae4bfaRxCUI 1946692, 1946698UNII R3459K699KUPC 0369751400010
- Pharmacologic class
- Nitroimidazole Antimicrobial
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
N469751040001followed by a unit qualifier and the quantityPackage 69751-0400-01. 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 .
Indications (excerpt from the label)
SOLOSEC ® is a nitroimidazole antimicrobial indicated for: Treatment of bacterial vaginosis in female patients 12 years of age and older. ( 1.1 ) Treatment of trichomoniasis in patients 12 years of age and older. ( 1.2 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of SOLOSEC and other antibacterial drugs, SOLOSEC should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. ( 1.3 ) 1.1 Bacterial Vaginosis SOLOSEC is indicated for the treatment of bacterial vaginosis in female patients 12 years of age and older [see Use in Specific Populations (8.1) and Clinical Studies (14) ]. 1.2 Trichomoniasis SOLO…
Excerpt only. Read the full label for complete information.
About NDC 69751-400
- What is NDC 69751-400?
- 69751-400 is the product NDC for Solosec (secnidazole), Secnidazole 2 g/4.8g granule, listed with the FDA by Evofem Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Solosec (Secnidazole).
- What is the active ingredient?
- Secnidazole.
- Who is the labeler?
- Evofem Inc., NDC labeler code 69751. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Solosec?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.