Prescription drug · BLA
Standardized Orchard Grass (dactylis glomerata) NDC 49643-343
Dactylis glomerata pollen 100000 [BAU]/mL · Injection · Cutaneous, Intradermal, Subcutaneous · Allermed Laboratories, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 49643-343-05 | 49643034305 | 5 mL in 1 VIAL, MULTI-DOSE (49643-343-05)Marketed from Dec 2, 1996 | |
| 49643-343-10 | 49643034310 | 10 mL in 1 VIAL, MULTI-DOSE (49643-343-10)Marketed from Dec 2, 1996 | |
| 49643-343-30 | 49643034330 | 30 mL in 1 VIAL, MULTI-DOSE (49643-343-30)Marketed from Dec 2, 1996 | |
| 49643-343-50 | 49643034350 | 50 mL in 1 VIAL, MULTI-DOSE (49643-343-50)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 Orchard Grass
- Generic name (nonproprietary)
- dactylis glomerata
- Active ingredients
- Dactylis glomerata pollen — 100000 [BAU]/mL
- Dosage form
- Injection
- Route
- Cutaneous, Intradermal, Subcutaneous
- Labeler
- Allermed Laboratories, Inc.
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 102217
- Marketing start
- Listing expires
- 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 49643-343_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 2KIK19R45Y, 175F461W10, HU8V6E7HOA, A0WFQ8P6N1, 83N78IDA7P, 4T81LB52R0, 65M88RW2EG, SCB8J7LS3T
- 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.
- NDC on a medical claim
N449643034305followed by a unit qualifier and the quantityPackage 49643-0343-05. 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 . 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.