What is NDC 49643-342?

49643-342 is the product NDC for Standardized Bermuda Grass (cynodon dactylon), Cynodon dactylon pollen 10000 [BAU]/mL injection, listed with the FDA by Allermed Laboratories, Inc.. It has 4 package NDCs, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Standardized Bermuda Grass (Cynodon dactylon).

Allermed Laboratories, Inc., NDC labeler code 49643. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Standardized Bermuda Grass?

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.

Standardized Bermuda Grass NDC 49643-342

NDC codes

FDA NDC Directory

Product NDC (as listed)49643-342Labeler and product segments. Claims need a package NDC.

Product NDC at billing width49643-0342Add 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
49643-342-05	49643034205	5 mL in 1 VIAL, MULTI-DOSE (49643-342-05)Marketed from Dec 2, 1996
49643-342-10	49643034210	10 mL in 1 VIAL, MULTI-DOSE (49643-342-10)Marketed from Dec 2, 1996
49643-342-30	49643034230	30 mL in 1 VIAL, MULTI-DOSE (49643-342-30)Marketed from Dec 2, 1996
49643-342-50	49643034250	50 mL in 1 VIAL, MULTI-DOSE (49643-342-50)Marketed from Dec 2, 1996

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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): Standardized Bermuda Grass
Generic name (nonproprietary): cynodon dactylon
Active ingredients: Cynodon dactylon pollen — 10000 [BAU]/mL
Dosage form: Injection
Route: Cutaneous, Intradermal, Subcutaneous
Labeler: Allermed Laboratories, Inc.NDC labeler code 49643
Product type: Prescription drug
Marketing category: BLA — Biologics License ApplicationApplication BLA 102214
Marketing start: Dec 2, 1996
Listing expires: Dec 31, 2026
Other FDA classes: Allergens (Chemical structure)Cell-mediated Immunity (Physiologic effect)Increased Histamine Release (Physiologic effect)Increased IgG Production (Physiologic effect)Pollen (Chemical structure)
Identifiers: Product ID 49643-342_36ad5f03-e686-f1d0-e063-6394a90adfe8SPL ID 36ad5f03-e686-f1d0-e063-6394a90adfe8SPL set ID d33c3aed-f487-45ed-a465-365170c6450aRxCUI 851873, 852157, 853027, 853047, 853278, 854054, 854162, 897496UNII 83N78IDA7P, A0WFQ8P6N1, HU8V6E7HOA, 4T81LB52R0, 65M88RW2EG, SCB8J7LS3T, 2KIK19R45Y, 175F461W10
Pharmacologic class: Standardized Pollen 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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

Administration

Drug administration (CPT 96360–96549)

When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.

How CPT relates to drug billing

NDC on a medical claim

N449643034205 followed by a unit qualifier and the quantity

Package 49643-0342-05. 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 Jun 3, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Standardized grass pollen extract is indicated for use in the diagnosis of grass allergy in patients with a history of allergic symptoms that occur during grass pollination. Skin tests with standardized grass pollen extract should be done first by the puncture method using 10,000 BAU/mL extract. If these tests are negative, they may be repeated by the puncture method with 100,000 BAU/mL extract, or by the intradermal method using an appropriate dilution (see DOSAGE AND ADMINISTRATION). The extract also is indicated for use in the treatment of allergic symptoms by immunotherapy in patients with a history of grass pollen allergy and established sensitivity to grass pollen…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 49643-342

What is NDC 49643-342?: 49643-342 is the product NDC for Standardized Bermuda Grass (cynodon dactylon), Cynodon dactylon pollen 10000 [BAU]/mL injection, listed with the FDA by Allermed Laboratories, Inc.. It has 4 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Standardized Bermuda Grass (Cynodon dactylon).
What is the active ingredient?: Cynodon dactylon pollen.
Who is the labeler?: Allermed Laboratories, Inc., NDC labeler code 49643. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Standardized Bermuda Grass?: 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.

Standardized Bermuda Grass (Cynodon dactylon) NDC 49643-342