NDC codes

FDA NDC Directory
Product NDC (as listed)0268-8024Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00268-8024Add 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
0268-8024-06002688024065.5 mL in 1 VIAL (0268-8024-06)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)
Birch Mix
Generic name (nonproprietary)
betula nigra pollen and betula populifolia pollen
Active ingredients
Betula nigra pollen — .05 g/mLBetula populifolia pollen — .05 g/mL
Dosage form
Injection, Solution
Route
Percutaneous
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)Allergens (Chemical structure)Cell-mediated Immunity (Physiologic effect)Cell-mediated Immunity (Physiologic effect)Increased Histamine Release (Physiologic effect)Increased Histamine Release (Physiologic effect)Increased IgG Production (Physiologic effect)Increased IgG Production (Physiologic effect)Pollen (Chemical structure)Pollen (Chemical structure)
Identifiers
Product ID 0268-8024_0521d788-9ddb-4e34-a990-62ccf60a4402SPL ID 0521d788-9ddb-4e34-a990-62ccf60a4402
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.

NDC on a medical claim

N400268802406 followed by a unit qualifier and the quantity

Package 00268-8024-06. 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 0268-8024

What is NDC 0268-8024?
0268-8024 is the product NDC for Birch Mix, Betula nigra pollen .05 g/mL; Betula populifolia pollen .05 g/mL injection, solution, listed with the FDA by ALK-Abello, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Birch Mix (BETULA NIGRA POLLEN and BETULA POPULIFOLIA POLLEN).
What is the active ingredient?
Betula nigra pollen, Betula populifolia 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 Birch Mix?
1 other product NDC are listed under this name. See all Birch Mix NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

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
Mold Mix Bepicoccum nigrum, gibberella zeae and mucor plumbeusEpicoccum nigrum .05 g/mL + 2 more ingredientsInjection, SolutionPercutaneous, SubcutaneousALK-Abello, Inc.0268-8112
Maple Mixacer negundo pollen and acer rubrum pollenAcer negundo pollen .05 g/mL; Acer rubrum pollen .05 g/mLInjection, SolutionPercutaneousALK-Abello, Inc.0268-8032
Sarocladium StrictumSarocladium strictum .05 g/mLInjection, SolutionPercutaneousALK-Abello, Inc.0268-8081
Epicoccum NigrumEpicoccum nigrum .05 g/mLInjection, SolutionPercutaneous, SubcutaneousALK-Abello, Inc.0268-8097
Riceoryza sativaWhite rice .1 g/mLInjection, SolutionPercutaneousALK-Abello, Inc.0268-6208
Amaranthus Retroflexus Pollenrough pigweedAmaranthus retroflexus pollen .05 g/mLInjection, SolutionPercutaneousALK-Abello, Inc.0268-6649
Lobsterhomarus americanusAmerican lobster .1 g/mLInjection, SolutionPercutaneousALK-Abello, Inc.0268-6174
Rumex Crispus Pollenyellow dockRumex crispus pollen .05 g/mLInjection, SolutionPercutaneousALK-Abello, Inc.0268-6622
Salsola Kali Pollenrussian thistleSalsola kali pollen .1 g/mLInjection, SolutionSubcutaneousALK-Abello, Inc.0268-1453
Celeryapium graveolensCelery .1 g/mLInjection, SolutionPercutaneousALK-Abello, Inc.0268-6120
Artemisia Vulgaris Pollenmugwort commonArtemisia vulgaris pollen .1 g/mLInjection, SolutionSubcutaneousALK-Abello, Inc.0268-1297
Amaranthus Spinosus Pollenpigweed spinyAmaranthus spinosus pollen .1 g/mLInjection, SolutionSubcutaneousALK-Abello, Inc.0268-1371
Morella Cerifera Pollenbayberry wax myrtleMorella cerifera pollen .1 g/mLInjection, SolutionSubcutaneousALK-Abello, Inc.0268-1041
Populus Deltoides Ssp Monilifera Pollencottonwood westernPopulus deltoides subsp. Monilifera pollen .1 g/mLInjection, SolutionSubcutaneousALK-Abello, Inc.0268-1138
Sorghum Halepense Pollenjohnson grassSorghum halepense pollen .05 g/mLInjection, SolutionSubcutaneousALK-Abello, Inc.0268-1215
RabbitRabbit .1 g/mLInjection, SolutionSubcutaneousALK-Abello, Inc.0268-0650
Cladosporium CladosporioidesCladosporium cladosporioides .05 g/mLInjection, SolutionPercutaneous, SubcutaneousALK-Abello, Inc.0268-8095
Mold Mix Aalternaria alternata, aspergillus fumigatus, cladosporium cladosporioides and penicillium chrysogenum var. chrysogenumAlternaria alternata .05 g/mL + 3 more ingredientsInjection, SolutionPercutaneous, SubcutaneousALK-Abello, Inc.0268-8110
WEED MIX Number 7Bamaranthus retroflexus pollen, artemisia vulgaris root, chenopodium album pollen, plantago lanceolata pollen, rumex acetosella pollen, rumex crispus pollen and strumarium pollenXanthium strumarium pollen .05 g/mL + 6 more ingredientsInjection, SolutionSubcutaneousALK-Abello, Inc.0268-8078
Amaranthus Tuberculatus Pollenwater hempAmaranthus tuberculatus pollen .025 g/mLInjection, SolutionPercutaneousALK-Abello, Inc.0268-6771

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