What is NDC 58264-0088?

58264-0088 is the product NDC for D-83-4 (candida albicans), Candida albicans 500 [hp_X]/mL solution, listed with the FDA by DNA Labs, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

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 D-83-4?

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.

D-83-4 NDC 58264-0088 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)58264-0088Labeler and product segments. Claims need a package NDC.

Product NDC at billing width58264-0088Add 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
58264-0088-1	5826400880158264008801	29.57 mL in 1 BOTTLE, GLASS (58264-0088-1)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): D-83-4
Generic name (nonproprietary): candida albicans
Active ingredients: Candida albicans — 500 [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: Allergens (Chemical structure)Cell-mediated Immunity (Physiologic effect)Fungal Proteins (Chemical structure)Increased Histamine Release (Physiologic effect)Increased IgG Production (Physiologic effect)
Identifiers: Product ID 58264-0088_2b9ec8dd-73b4-e366-e063-6394a90ae792SPL ID 2b9ec8dd-73b4-e366-e063-6394a90ae792SPL set ID 946e4de4-04a3-42c2-ba23-e79eda234807UNII 4D7G21HDBC
Pharmacologic class: Non-Standardized Fungal Allergenic Extract

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

N458264008801 followed by a unit qualifier and the quantity

Package 58264-0088-01. 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 13, 2025.

Indications (excerpt from the label)

INDICATIONS Sensitivity to molds, yeast infection, bladder infection.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 58264-0088

What is NDC 58264-0088?: 58264-0088 is the product NDC for D-83-4 (candida albicans), Candida albicans 500 [hp_X]/mL 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?: D-83-4 (Candida albicans).
What is the active ingredient?: Candida albicans.
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 D-83-4?: 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.

D-83-4 (Candida albicans) NDC 58264-0088