NDC codes

FDA NDC Directory
Product NDC (as listed)69676-0054Labeler and product segments. Claims need a package NDC.
Product NDC at billing width69676-0054Add 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
69676-0054-169676005401696760054011 BOTTLE, PLASTIC in 1 CARTON (69676-0054-1) / 60 TABLET, CHEWABLE in 1 BOTTLE, PLASTICMarketed from Feb 1, 2021

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)
Genexa Kids Calm Keeper
Generic name (nonproprietary)
aconitum napellus, calcarea phosphorica, chamomilla, gelsemium sepervirens, ignatia amara, kali carbonicum, passiflora incarnata, valeriana officinalis
Active ingredients
Tribasic calcium phosphate — 8 [hp_X]/1Matricaria chamomilla whole — 6 [hp_X]/1Gelsemium sempervirens root — 12 [hp_X]/1Strychnos ignatii seed — 12 [hp_X]/1Potassium carbonate — 8 [hp_X]/1Valerian — 3 [hp_X]/1Passiflora incarnata flowering top — 3 [hp_X]/1Aconitum napellus — 12 [hp_X]/1
Dosage form
Tablet, Chewable
Route
Oral
Labeler
Genexa Inc.NDC labeler code 69676
Product type
Over-the-counter drug
Marketing category
Unapproved homeopathic
Marketing start
Listing expires
Other FDA classes
Calcium (Chemical structure)Divalent (Chemical structure)Increased Coagulation Factor Activity (Physiologic effect)Phosphate Chelating Activity (Mechanism)
Identifiers
Product ID 69676-0054_4471ce51-53e1-f3bd-e063-6294a90a4898SPL ID 4471ce51-53e1-f3bd-e063-6294a90a4898SPL set ID ba5de524-dac6-8b54-e053-2995a90ac6efUNII 91D9GV0Z28, G0R4UBI2ZZ, 639KR60Q1Q, 1NM3M2487K, BQN1B9B9HA, JWF5YAW3QW, CLF5YFS11O, U0NQ8555JDUPC 0857630006106
Pharmacologic class
Blood Coagulation Factor; Phosphate Binder

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

N469676005401 followed by a unit qualifier and the quantity

Package 69676-0054-01. 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)

Uses* addresses the following symptoms associated with stress: irritability sleeplessness restlessness nervousness oversensitivity

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 69676-0054

What is NDC 69676-0054?
69676-0054 is the product NDC for Genexa Kids Calm Keeper, Tribasic calcium phosphate 8 [hp_X]/1 + 7 more ingredients tablet, chewable, listed with the FDA by Genexa Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Genexa Kids Calm Keeper (Aconitum napellus, Calcarea phosphorica, Chamomilla, Gelsemium sepervirens, Ignatia amara, Kali carbonicum, Passiflora incarnata, Valeriana officinalis).
What is the active ingredient?
Tribasic calcium phosphate, Matricaria chamomilla whole, Gelsemium sempervirens root, Strychnos ignatii seed, Potassium carbonate, Valerian, Passiflora incarnata flowering top, Aconitum napellus.
Who is the labeler?
Genexa Inc., NDC labeler code 69676. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Genexa Kids Calm Keeper?
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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