NDC codes

FDA NDC Directory
Product NDC (as listed)0268-3050Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00268-3050Add 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
0268-3050-06002683050065 mL in 1 VIAL, MULTI-DOSE (0268-3050-06)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)
Bermuda Grass, Standardized
Generic name (nonproprietary)
bermuda grass, standardized
Active ingredients
Cynodon dactylon pollen — 10000 [BAU]/mL
Dosage form
Solution
Route
Percutaneous
Labeler
ALK-Abello, Inc.NDC labeler code 0268
Product type
Standardized allergenic
Marketing category
BLA — Biologics License ApplicationApplication BLA 103051
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 0268-3050_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.

NDC on a medical claim

N400268305006 followed by a unit qualifier and the quantity

Package 00268-3050-06. 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 0268-3050

What is NDC 0268-3050?
0268-3050 is the product NDC for Bermuda Grass, Standardized, Cynodon dactylon pollen 10000 [BAU]/mL 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?
Bermuda Grass, Standardized.
What is the active ingredient?
Cynodon dactylon 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 Bermuda Grass, Standardized?
1 other product NDC are listed under this name. See all Bermuda 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 Bermuda Grass, Standardized NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Bermuda Grass, StandardizedCynodon dactylon pollen 10000 [BAU]/mLInjection, SolutionSubcutaneousALK-Abello, Inc.0268-029300268-0293-1000268-0293-3000268-0293-50

Other NDCs under BLA 103051

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

FDA NDC Directory listings under BLA 103051
ProductStrengthForm · routeLabelerProduct NDC
Bermuda Grass, StandardizedCynodon dactylon pollen 10000 [BAU]/mLInjection, SolutionSubcutaneousALK-Abello, Inc.0268-0293

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