NDC codes

FDA NDC Directory
Product NDC (as listed)0268-0291Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00268-0291Add 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
0268-0291-100026802911010 mL in 1 VIAL, MULTI-DOSE (0268-0291-10)Marketed from Dec 18, 1997
0268-0291-500026802915050 mL in 1 VIAL, MULTI-DOSE (0268-0291-50)Marketed from Dec 18, 1997

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)
Meadow Fescue Grass, Standardized
Generic name (nonproprietary)
meadow fescue grass, standardized
Active ingredients
Festuca pratensis pollen — 100000 [BAU]/mL
Dosage form
Injection, Solution
Route
Subcutaneous
Labeler
ALK-Abello, Inc.NDC labeler code 0268
Product type
Standardized allergenic
Marketing category
BLA — Biologics License ApplicationApplication BLA 103053
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 0268-0291_2e2db5ce-9bd5-4ad3-94c0-45e59370fb28SPL ID 2e2db5ce-9bd5-4ad3-94c0-45e59370fb28
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

N400268029110 followed by a unit qualifier and the quantity

Package 00268-0291-10. 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 0268-0291

What is NDC 0268-0291?
0268-0291 is the product NDC for Meadow Fescue Grass, Standardized, Festuca pratensis pollen 100000 [BAU]/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?
Meadow Fescue Grass, Standardized.
What is the active ingredient?
Festuca pratensis 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 Meadow Fescue Grass, Standardized?
1 other product NDC are listed under this name. See all Meadow Fescue Grass, Standardized 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 Meadow Fescue Grass, Standardized NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Meadow Fescue Grass, StandardizedFestuca pratensis pollen 100000 [BAU]/mLSolutionPercutaneousALK-Abello, Inc.0268-305300268-3053-06

Other NDCs under BLA 103053

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

FDA NDC Directory listings under BLA 103053
ProductStrengthForm · routeLabelerProduct NDC
Meadow Fescue Grass, StandardizedFestuca pratensis pollen 100000 [BAU]/mLSolutionPercutaneousALK-Abello, Inc.0268-3053

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