NDC codes

FDA NDC Directory
Product NDC (as listed)49643-450Labeler and product segments. Claims need a package NDC.
Product NDC at billing width49643-0450Add 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 NDC11-digit (billing)PackageCopy
49643-450-05496430450055 mL in 1 VIAL, MULTI-DOSE (49643-450-05)Marketed from Mar 12, 1974
49643-450-104964304501010 mL in 1 VIAL, MULTI-DOSE (49643-450-10)Marketed from Mar 12, 1974
49643-450-304964304503030 mL in 1 VIAL, MULTI-DOSE (49643-450-30)Marketed from Mar 12, 1974
49643-450-504964304505050 mL in 1 VIAL, MULTI-DOSE (49643-450-50)Marketed from Mar 12, 1974

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)
Red Oak Pollen
Generic name (nonproprietary)
quercus rubra
Active ingredients
Quercus rubra pollen — .05 g/mL
Dosage form
Injection
Route
Cutaneous, Intradermal, Subcutaneous
Labeler
Allermed Laboratories, Inc.NDC labeler code 49643
Product type
Non-standardized allergenic
Marketing category
BLA — Biologics License ApplicationApplication BLA 102211
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 49643-450_36ad1e17-751d-e226-e063-6394a90ab328SPL ID 36ad1e17-751d-e226-e063-6394a90ab328
Pharmacologic class
Non-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

N449643045005 followed by a unit qualifier and the quantity

Package 49643-0450-05. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 49643-450

What is NDC 49643-450?
49643-450 is the product NDC for Red Oak Pollen (quercus rubra), Quercus rubra pollen .05 g/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?
Red Oak Pollen (Quercus rubra).
What is the active ingredient?
Quercus rubra 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 Red Oak Pollen?
7 other product NDCs are listed under this name. See all Red Oak Pollen NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Red Oak Pollen NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Red Oak Pollenquercus rubraQuercus rubra pollen .05 g/mLSolutionIntradermal, Percutaneous, SubcutaneousGreer Laboratories, Inc.22840-545322840-5453-0222840-5453-0322840-5453-04+1 more
Red Oak Pollenquercus rubraQuercus rubra pollen 40000 [PNU]/mLSolutionIntradermal, Percutaneous, SubcutaneousGreer Laboratories, Inc.22840-249322840-2493-0222840-2493-04
Red Oak Pollenquercus rubraQuercus rubra pollen .1 g/mLSolutionIntradermal, Percutaneous, SubcutaneousGreer Laboratories, Inc.22840-249022840-2490-0222840-2490-04
Red Oak Pollenquercus rubraQuercus rubra pollen 10000 [PNU]/mLSolutionIntradermal, Percutaneous, SubcutaneousGreer Laboratories, Inc.22840-249122840-2491-02
Red Oak Pollenquercus rubraQuercus rubra pollen 20000 [PNU]/mLSolutionIntradermal, Percutaneous, SubcutaneousGreer Laboratories, Inc.22840-249222840-2492-0222840-2492-04
Red Oak Pollenquercus rubraQuercus rubra pollen .05 g/mLSolutionIntradermal, Percutaneous, SubcutaneousGreer Laboratories, Inc.22840-249422840-2494-0222840-2494-04
Red Oak Pollenquercus rubraQuercus rubra pollen .001 g/mLSolutionIntradermal, Percutaneous, SubcutaneousGreer Laboratories, Inc.22840-249522840-2495-01

Other NDCs under BLA 102211

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under BLA 102211
ProductStrengthForm · routeLabelerProduct NDC
Yellow Pine Pollenpinus ponderosaPinus ponderosa pollen .05 g/mLInjectionCutaneous, Intradermal, SubcutaneousAllermed Laboratories, Inc.49643-449
Red Mulberry Pollenmorus rubraMorus rubra pollen .05 g/mLInjectionCutaneous, Intradermal, SubcutaneousAllermed Laboratories, Inc.49643-447
Shortleaf Pine Pollenpinus echinataPinus echinata pollen .05 g/mLInjectionCutaneous, Intradermal, SubcutaneousAllermed Laboratories, Inc.49643-448
Linden Pollentilia cordataTilia cordata pollen .05 g/mLInjectionCutaneous, Intradermal, SubcutaneousAllermed Laboratories, Inc.49643-460
Black Oak Pollenquercus velutinaQuercus velutina pollen .05 g/mLInjectionCutaneous, Intradermal, SubcutaneousAllermed Laboratories, Inc.49643-451
Hard Maple Pollenacer saccharumAcer saccharum pollen .05 g/mLInjectionCutaneous, Intradermal, SubcutaneousAllermed Laboratories, Inc.49643-452
Alder Mixalnus rhombifolia/alnus rubra/alnus rugosaAlnus rhombifolia pollen .0167 g/mL + 2 more ingredientsLiquidPercutaneous, SubcutaneousAllermed Laboratories, Inc.49643-501
Maple, California Mixacer macrophyllum/acer negundoAcer negundo pollen .025 g/mL; Acer macrophyllum pollen .025 g/mLLiquidPercutaneous, SubcutaneousAllermed Laboratories, Inc.49643-520
Pine Mixpinus echinata/pinus ponderosa/pinus strobusPinus echinata pollen .0167 g/mL + 2 more ingredientsLiquidPercutaneous, SubcutaneousAllermed Laboratories, Inc.49643-524
Walnut MixJuglans nigra pollen .0167 g/mL + 2 more ingredientsInjectionPercutaneous, SubcutaneousAllermed Laboratories, Inc.49643-544
Trichophyton Mixtrichophyton mentagrophytes/trichophyton rubrumTrichophyton rubrum .005 g/mL; Trichophyton mentagrophytes .0005 g/mLLiquidPercutaneous, SubcutaneousAllermed Laboratories, Inc.49643-802
Glycerol-Saline Controlglycerol-saline diluentGlycerin .53 g/mLInjectionCutaneous, Intradermal, SubcutaneousAllermed Laboratories, Inc.49643-818
CottonseedCotton seed .1 g/mLInjectionCutaneous, Intradermal, SubcutaneousAllermed Laboratories, Inc.49643-005
Cattle EpitheliaBos taurus skin .1 g/mLInjectionCutaneous, Intradermal, SubcutaneousAllermed Laboratories, Inc.49643-003
Cotton LintersCotton fiber .1 g/mLInjectionCutaneous, Intradermal, SubcutaneousAllermed Laboratories, Inc.49643-004
House DustHouse dust .02 g/mLInjectionCutaneous, Intradermal, SubcutaneousAllermed Laboratories, Inc.49643-008
Dog HairCanis lupus familiaris hair .1 g/mLInjectionCutaneous, Intradermal, SubcutaneousAllermed Laboratories, Inc.49643-006
Hamster EpitheliaMesocricetus auratus skin .05 g/mLInjectionCutaneous, Intradermal, SubcutaneousAllermed Laboratories, Inc.49643-013
FlaxseedFlax seed .05 g/mLInjectionCutaneous, Intradermal, SubcutaneousAllermed Laboratories, Inc.49643-010
Goat EpitheliaCapra hircus skin .05 g/mLInjectionCutaneous, Intradermal, SubcutaneousAllermed Laboratories, Inc.49643-011

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