NDC codes

FDA NDC Directory
Product NDC (as listed)53645-2021Labeler and product segments. Claims need a package NDC.
Product NDC at billing width53645-2021Add 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
53645-2021-65364520210630 mL in 1 BOTTLE (53645-2021-6)Marketed from Oct 7, 2024

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)
Granite 30X
Generic name (nonproprietary)
granite 30x
Active ingredients
Silicon dioxide — 30 [hp_X]/30mLMica — 30 [hp_X]/30mL
Dosage form
Liquid
Route
Oral
Labeler
True Botanica, LLCNDC labeler code 53645
Product type
Over-the-counter drug
Marketing category
Unapproved homeopathic
Marketing start
Listing expires
Identifiers
Product ID 53645-2021_21b271f4-a129-a54d-e063-6394a90adc6eSPL ID 21b271f4-a129-a54d-e063-6394a90adc6eSPL set ID 21b2bae6-8176-ccbf-e063-6394a90a97b5UNII ETJ7Z6XBU4, V8A1AW0880

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

N453645202106 followed by a unit qualifier and the quantity

Package 53645-2021-06. 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)

Use: For temporary relief of nervous tremor, occasional headache. Supports healthy brain/nerves metabolism. May also be used for standard homeopathic indications or as directed by your physician.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 53645-2021

What is NDC 53645-2021?
53645-2021 is the product NDC for Granite 30X, Silicon dioxide 30 [hp_X]/30mL; Mica 30 [hp_X]/30mL liquid, listed with the FDA by True Botanica, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Granite 30X.
What is the active ingredient?
Silicon dioxide, Mica.
Who is the labeler?
True Botanica, LLC, NDC labeler code 53645. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Granite 30X?
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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