NDC codes

FDA NDC Directory
Product NDC (as listed)0268-1080Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00268-1080Add 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
0268-1080-100026810801010 mL in 1 VIAL, MULTI-DOSE (0268-1080-10)Marketed from Jan 1, 1965
0268-1080-500026810805050 mL in 1 VIAL, MULTI-DOSE (0268-1080-50)Marketed from Jan 1, 1965

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
Acer Negundo Pollen
Generic name (nonproprietary)
box elder ash leaf maple
Active ingredients
Acer negundo pollen — .1 g/mL
Dosage form
Injection, Solution
Route
Subcutaneous
Labeler
ALK-Abello, Inc.NDC labeler code 0268
Product type
Non-standardized allergenic
Marketing category
BLA — Biologics License ApplicationApplication BLA 103753
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 0268-1080_a3200b5f-95f3-43cf-a26f-27a503470956SPL ID a3200b5f-95f3-43cf-a26f-27a503470956
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

N400268108010 followed by a unit qualifier and the quantity

Package 00268-1080-10. 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 0268-1080

What is NDC 0268-1080?
0268-1080 is the product NDC for Acer Negundo Pollen (box elder ash leaf maple), Acer negundo pollen .1 g/mL injection, solution, listed with the FDA by ALK-Abello, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Acer Negundo Pollen (Box Elder Ash Leaf Maple).
What is the active ingredient?
Acer negundo pollen.
Who is the labeler?
ALK-Abello, Inc., NDC labeler code 0268. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Acer Negundo Pollen?
2 other product NDCs are listed under this name. See all Acer Negundo 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 Acer Negundo Pollen NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Acer Negundo Pollenbox elder ash leaf mapleAcer negundo pollen .05 g/mLInjection, SolutionSubcutaneousALK-Abello, Inc.0268-108100268-1081-1000268-1081-50
Acer Negundo Pollenbox elder ash leaf mapleAcer negundo pollen .05 g/mLInjection, SolutionPercutaneousALK-Abello, Inc.0268-661200268-6612-06

Other NDCs under BLA 103753

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

FDA NDC Directory listings under BLA 103753
ProductStrengthForm · routeLabelerProduct NDC
Paspalum Notatum Pollenbahia grassPaspalum notatum pollen .05 g/mLInjection, SolutionSubcutaneousALK-Abello, Inc.0268-1035
Populus Deltoides Pollencottonwood eastern commonPopulus deltoides pollen .05 g/mLInjection, SolutionSubcutaneousALK-Abello, Inc.0268-1127
Sorghum Halepense Pollenjohnson grassSorghum halepense pollen .1 g/mLInjection, SolutionSubcutaneousALK-Abello, Inc.0268-1214
Caseinbos taurusCasein .1 g/mLInjection, SolutionPercutaneousALK-Abello, Inc.0268-6118
Lima Beanphaseolus lunatusLima bean .1 g/mLInjection, SolutionPercutaneousALK-Abello, Inc.0268-6173
Rumex Acetosella Pollensour dock sheep sorrelRumex acetosella pollen .05 g/mLInjection, SolutionPercutaneousALK-Abello, Inc.0268-6621
Ambrosia Psilostachya Pollenragweed westernAmbrosia psilostachya pollen .05 g/mLInjection, SolutionSubcutaneousALK-Abello, Inc.0268-1446
Prosopis Juliflora PollenmesquiteProsopis juliflora pollen .05 g/mLInjection, SolutionSubcutaneousALK-Abello, Inc.0268-1280
Amaranthus Retroflexus Pollenpigweed rough redrootAmaranthus retroflexus pollen .05 g/mLInjection, SolutionSubcutaneousALK-Abello, Inc.0268-1365
Saccharomyces CerevisiaeSaccharomyces cerevisiae .05 g/mLInjection, SolutionPercutaneousALK-Abello, Inc.0268-8106
Canis Lupus Familiaris Skindog epitheliaCanis lupus familiaris skin .05 [PNU]/mLInjection, SolutionSubcutaneousALK-Abello, Inc.0268-0621
Cabbagebrassica oleracea var. capitataCabbage .1 g/mLInjection, SolutionPercutaneousALK-Abello, Inc.0268-6114
Botrytis CinereaBotrytis cinerea .05 g/mLInjection, SolutionPercutaneousALK-Abello, Inc.0268-8091
Birch Mixbetula nigra pollen and betula populifolia pollenBetula nigra pollen .05 g/mL; Betula populifolia pollen .05 g/mLInjection, SolutionPercutaneousALK-Abello, Inc.0268-8024
Canis Lupus Familiaris Skindog epitheliumCanis lupus familiaris skin .05 g/mLInjection, SolutionPercutaneousALK-Abello, Inc.0268-6306
Oak Mixquercus rubra, quercus alba, quercus virginianaQuercus rubra pollen .05 g/mL + 2 more ingredientsInjection, SolutionSubcutaneousALK-Abello, Inc.0268-8070
Schinus Molle Pollencalifornia pepper treeSchinus molle pollen .05 g/mLInjection, SolutionPercutaneousALK-Abello, Inc.0268-6743
Lambovis ariesLamb .1 g/mLInjection, SolutionPercutaneousALK-Abello, Inc.0268-6149
Plumprunus domesticaPlum .1 g/mLInjection, SolutionPercutaneousALK-Abello, Inc.0268-6203
Populus Deltoides Polleneastern cottonwood commonPopulus deltoides pollen .05 g/mLInjection, SolutionPercutaneousALK-Abello, Inc.0268-6618

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Acer Negundo Pollen NDC 0268-1080 | National Drug Code | Med-Code