NDC codes

FDA NDC Directory
Product NDC (as listed)34666-008Labeler and product segments. Claims need a package NDC.
Product NDC at billing width34666-0008Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
34666-008-0634666000806346660008066 TABLET in 1 BOX (34666-008-06)Marketed from Dec 23, 2010
34666-008-60346660008603466600086060 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

N434666000806 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

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.

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