What is NDC 58264-0344?

58264-0344 is the product NDC for Am-5, Helleborus niger whole 8 [hp_X]/mL + 2 more ingredients solution, listed with the FDA by DNA Labs, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Am-5 (HELLEBORUS NIGER WHOLE, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, and BOS TAURUS BILE).

What is the active ingredient?

Helleborus niger whole, Magnesium phosphate, Dibasic trihydrate, Bos taurus bile.

DNA Labs, Inc., NDC labeler code 58264. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Am-5?

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.

Am-5 NDC 58264-0344 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)58264-0344Labeler and product segments. Claims need a package NDC.

Product NDC at billing width58264-0344Add 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 NDC	11-digit (billing)	Package	Copy
58264-0344-1	5826403440158264034401	29.57 mL in 1 BOTTLE, GLASS (58264-0344-1)Marketed from Jan 1, 1990

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): Am-5
Generic name (nonproprietary): helleborus niger whole, magnesium phosphate, dibasic trihydrate, and bos taurus bile
Active ingredients: Helleborus niger whole — 8 [hp_X]/mLMagnesium phosphate, Dibasic trihydrate — 8 [hp_X]/mLBos taurus bile — 12 [hp_X]/mL
Dosage form: Solution
Route: Sublingual
Labeler: DNA Labs, Inc.NDC labeler code 58264
Product type: Over-the-counter drug
Marketing category: Unapproved homeopathic
Marketing start: Jan 1, 1990
Listing expires: Dec 31, 2026
Other FDA classes: Increased Large Intestinal Motility (Physiologic effect)Inhibition Large Intestine Fluid/Electrolyte Absorption (Physiologic effect)Inhibition Small Intestine Fluid/Electrolyte Absorption (Physiologic effect)Magnesium Ion Exchange Activity (Mechanism)Osmotic Activity (Mechanism)Stimulation Large Intestine Fluid/Electrolyte Secretion (Physiologic effect)
Identifiers: Product ID 58264-0344_2b52dd9d-5dee-a801-e063-6294a90aeffaSPL ID 2b52dd9d-5dee-a801-e063-6294a90aeffaSPL set ID 0d4b5527-cc14-4dd0-84d9-b403e281f1feUNII H0NO2VNJ61, HF539G9L3Q, ET3651ZLOU
Pharmacologic class: Calculi Dissolution Agent; Osmotic Laxative

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. Sublingual products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N458264034401 followed by a unit qualifier and the quantity

Package 58264-0344-01. 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 Jan 9, 2025.

Indications (excerpt from the label)

INDICATIONS Regulates energy flow in the large intestine meridian.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 58264-0344

What is NDC 58264-0344?: 58264-0344 is the product NDC for Am-5, Helleborus niger whole 8 [hp_X]/mL + 2 more ingredients solution, listed with the FDA by DNA Labs, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Am-5 (HELLEBORUS NIGER WHOLE, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, and BOS TAURUS BILE).
What is the active ingredient?: Helleborus niger whole, Magnesium phosphate, Dibasic trihydrate, Bos taurus bile.
Who is the labeler?: DNA Labs, Inc., NDC labeler code 58264. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Am-5?: 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.