NDC codes

FDA NDC Directory
Product NDC (as listed)53645-1581Labeler and product segments. Claims need a package NDC.
Product NDC at billing width53645-1581Add 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
53645-1581-6536451581065364515810630 mL in 1 BOTTLE (53645-1581-6)Marketed from Nov 19, 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)
Histaminum Hydrochloricum 30X
Generic name (nonproprietary)
histaminum hydrochloricum 30x
Active ingredients
Histamine dihydrochloride — 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 53645-1581_1f1dbf41-cb8a-37d4-e063-6394a90ae294SPL ID 1f1dbf41-cb8a-37d4-e063-6394a90ae294SPL set ID 1f1dcae4-6076-3a67-e063-6294a90a5543UNII 3POA0Q644U

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

N453645158106 followed by a unit qualifier and the quantity

Package 53645-1581-06. 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 allergic reactions. 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 53645-1581

What is NDC 53645-1581?
53645-1581 is the product NDC for Histaminum Hydrochloricum 30X, Histamine dihydrochloride 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?
Histaminum Hydrochloricum 30X.
What is the active ingredient?
Histamine dihydrochloride.
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 Histaminum Hydrochloricum 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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