What is NDC 58264-0314?

58264-0314 is the product NDC for A-22, Aspergillus flavus 30 [hp_X]/mL + 8 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?

A-22 (ASPERGILLUS FLAVUS, ASPERGILLUS FUMIGATUS, EUROTIUM HERBARIORUM, ASPERGILLUS NIDULANS, ASPERGILLUS NIGER VAR. NIGER, PENICILLIUM CAMEMBERTI, PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM, PENICILLIUM DIGITATUM, and PENICILLIUM ROQUEFORTI).

What is the active ingredient?

Aspergillus flavus, Aspergillus fumigatus, Eurotium herbariorum, Aspergillus nidulans, Aspergillus niger var. Niger, Penicillium camemberti, Penicillium chrysogenum var. Chrysogenum, Penicillium digitatum, Penicillium roqueforti.

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 A-22?

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.

A-22 NDC 58264-0314 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)58264-0314Labeler and product segments. Claims need a package NDC.

Product NDC at billing width58264-0314Add 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
58264-0314-1	58264031401	29.57 mL in 1 BOTTLE, GLASS (58264-0314-1)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): A-22
Generic name (nonproprietary): aspergillus flavus, aspergillus fumigatus, eurotium herbariorum, aspergillus nidulans, aspergillus niger var. niger, penicillium camemberti, penicillium chrysogenum var. chrysogenum, penicillium digitatum, and penicillium roqueforti
Active ingredients: Aspergillus flavus — 30 [hp_X]/mLAspergillus fumigatus — 30 [hp_X]/mLEurotium herbariorum — 30 [hp_X]/mLAspergillus nidulans — 30 [hp_X]/mLAspergillus niger var. Niger — 30 [hp_X]/mLPenicillium camemberti — 30 [hp_X]/mLPenicillium chrysogenum var. Chrysogenum — 30 [hp_X]/mLPenicillium digitatum — 30 [hp_X]/mLPenicillium roqueforti — 30 [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)Allergens (Chemical structure)Allergens (Chemical structure)Allergens (Chemical structure)Allergens (Chemical structure)Allergens (Chemical structure)Allergens (Chemical structure)Allergens (Chemical structure)Allergens (Chemical structure)Cell-mediated Immunity (Physiologic effect)Cell-mediated Immunity (Physiologic effect)Cell-mediated Immunity (Physiologic effect)Cell-mediated Immunity (Physiologic effect)Cell-mediated Immunity (Physiologic effect)Cell-mediated Immunity (Physiologic effect)Cell-mediated Immunity (Physiologic effect)Cell-mediated Immunity (Physiologic effect)Cell-mediated Immunity (Physiologic effect)Fungal Proteins (Chemical structure)Fungal Proteins (Chemical structure)Fungal Proteins (Chemical structure)Fungal Proteins (Chemical structure)Fungal Proteins (Chemical structure)Fungal Proteins (Chemical structure)Fungal Proteins (Chemical structure)Fungal Proteins (Chemical structure)Fungal Proteins (Chemical structure)Increased Histamine Release (Physiologic effect)Increased Histamine Release (Physiologic effect)Increased Histamine Release (Physiologic effect)Increased Histamine Release (Physiologic effect)Increased Histamine Release (Physiologic effect)Increased Histamine Release (Physiologic effect)Increased Histamine Release (Physiologic effect)Increased Histamine Release (Physiologic effect)Increased Histamine Release (Physiologic effect)Increased IgG Production (Physiologic effect)Increased IgG Production (Physiologic effect)Increased IgG Production (Physiologic effect)Increased IgG Production (Physiologic effect)Increased IgG Production (Physiologic effect)Increased IgG Production (Physiologic effect)Increased IgG Production (Physiologic effect)
Identifiers: Product ID 58264-0314_2b50d0ac-9542-eba3-e063-6394a90ade3dSPL ID 2b50d0ac-9542-eba3-e063-6394a90ade3dSPL set ID b8a80814-603c-4941-bc2d-4f3d888769a6UNII 3J888Y9L13, X88DF51T48, 49W168AES4, 242A53RB80, 9IOA40ANG6, T069R9OPVG, 3Y1PE1GCIG, 1SB49SV239, 7ORP6R724L
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

N458264031401 followed by a unit qualifier and the quantity

Package 58264-0314-01. 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 Allergies.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 58264-0314

What is NDC 58264-0314?: 58264-0314 is the product NDC for A-22, Aspergillus flavus 30 [hp_X]/mL + 8 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?: A-22 (ASPERGILLUS FLAVUS, ASPERGILLUS FUMIGATUS, EUROTIUM HERBARIORUM, ASPERGILLUS NIDULANS, ASPERGILLUS NIGER VAR. NIGER, PENICILLIUM CAMEMBERTI, PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM, PENICILLIUM DIGITATUM, and PENICILLIUM ROQUEFORTI).
What is the active ingredient?: Aspergillus flavus, Aspergillus fumigatus, Eurotium herbariorum, Aspergillus nidulans, Aspergillus niger var. Niger, Penicillium camemberti, Penicillium chrysogenum var. Chrysogenum, Penicillium digitatum, Penicillium roqueforti.
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 A-22?: 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.