Over-the-counter drug · UNAPPROVED HOMEOPATHIC
Simplex NDC 34666-008
passiflora incarnata, ignatia amara, valeriana officinalis · Passiflora incarnata flower 3 [hp_X]/1 + 2 more ingredients · Tablet · Oral · Nartex Laboratories
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 34666-008-06 | 3466600080634666000806 | 6 TABLET in 1 BOX (34666-008-06)Marketed from Dec 23, 2010 | |
| 34666-008-60 | 3466600086034666000860 | 60 TABLET in 1 BOX (34666-008-60)Marketed from Dec 23, 2010 |
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)
- Simplex
- Generic name (nonproprietary)
- passiflora incarnata, ignatia amara, valeriana officinalis
- Active ingredients
- Passiflora incarnata flower — 3 [hp_X]/1Strychnos ignatii seed — 3 [hp_X]/1Valerian — 3 [hp_X]/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Nartex LaboratoriesNDC labeler code 34666
- Product type
- Over-the-counter drug
- Marketing category
- Unapproved homeopathic
- Marketing start
- Listing expires
- Identifiers
- Product ID 34666-008_47467544-a0d0-1d4e-e063-6394a90a1bb3SPL ID 47467544-a0d0-1d4e-e063-6394a90a1bb3SPL set ID d9047378-5d03-4ef5-98f9-3eb78840222cUNII K8F3G29S6Z, 1NM3M2487K, JWF5YAW3QW
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
N434666000806followed by a unit qualifier and the quantityPackage 34666-0008-06. 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)
For relief of symptoms of sleeplessness and stress as per homeopathic materia medica. Claims based on traditional homeopathic practice, not accepted medical evidence. These uses have not been evaluated by FDA, and poduct has not been clinically tested.
Excerpt only. Read the full label for complete information.
About NDC 34666-008
- What is NDC 34666-008?
- 34666-008 is the product NDC for Simplex, Passiflora incarnata flower 3 [hp_X]/1 + 2 more ingredients tablet, listed with the FDA by Nartex Laboratories. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Simplex (Passiflora incarnata, Ignatia Amara, Valeriana Officinalis).
- What is the active ingredient?
- Passiflora incarnata flower, Strychnos ignatii seed, Valerian.
- Who is the labeler?
- Nartex Laboratories, NDC labeler code 34666. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Simplex?
- 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.