NDC codes

FDA NDC Directory
Product NDC (as listed)0268-8081Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00268-8081Add 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
0268-8081-10002688081100026880811010.5 mL in 1 VIAL (0268-8081-10)Marketed from Jan 1, 1965
0268-8081-50002688081500026880815053 mL in 1 VIAL (0268-8081-50)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)
Sarocladium Strictum
Generic name (nonproprietary)
sarocladium strictum
Active ingredients
Sarocladium strictum — .05 g/mL
Dosage form
Injection, Solution
Route
Percutaneous, 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)Fungal Proteins (Chemical structure)Increased Histamine Release (Physiologic effect)Increased IgG Production (Physiologic effect)
Identifiers
Product ID 0268-8081_8c93c301-de0c-466d-b914-7ec864c7c0a6SPL ID 8c93c301-de0c-466d-b914-7ec864c7c0a6
Pharmacologic class
Non-Standardized Fungal 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

N400268808110 followed by a unit qualifier and the quantity

Package 00268-8081-10. 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 0268-8081

What is NDC 0268-8081?
0268-8081 is the product NDC for Sarocladium Strictum, Sarocladium strictum .05 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?
Sarocladium Strictum.
What is the active ingredient?
Sarocladium strictum.
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 Sarocladium Strictum?
1 other product NDC are listed under this name. See all Sarocladium Strictum 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 Sarocladium Strictum NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Sarocladium StrictumSarocladium strictum .1 g/mLInjection, SolutionSubcutaneousALK-Abello, Inc.0268-808000268-8080-1000268-8080-50

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
Liquidambar Styraciflua PollensweetgumLiquidambar styraciflua pollen .05 g/mLInjection, SolutionSubcutaneousALK-Abello, Inc.0268-1494
Morus Rubra Pollenmulberry redMorus rubra pollen .1 g/mLInjection, SolutionSubcutaneousALK-Abello, Inc.0268-1304
Plantago Lanceolata Pollenplantain englishPlantago lanceolata pollen .1 g/mLInjection, SolutionSubcutaneousALK-Abello, Inc.0268-1394
Fraxinus Americana Pollenwhite ashFraxinus americana pollen .05 g/mLInjection, SolutionPercutaneousALK-Abello, Inc.0268-6603
Nettleurtica dioica pollenUrtica dioica pollen .05 g/mLInjection, SolutionPercutaneousALK-Abello, Inc.0268-7110
Codfishgadus morhuaAtlantic cod .1 g/mLInjection, SolutionPercutaneousALK-Abello, Inc.0268-6128
Squashcurcubita pepoZucchini .1 g/mLInjection, SolutionPercutaneousALK-Abello, Inc.0268-6219
Artemisia Tridentata Pollencommon sagebrushArtemisia tridentata pollen .05 g/mLInjection, SolutionPercutaneousALK-Abello, Inc.0268-6670
Applemalus domesticaApple .1 g/mLInjection, SolutionPercutaneousALK-Abello, Inc.0268-6101
Onionallium cepaOnion .1 g/mLInjection, SolutionPercutaneousALK-Abello, Inc.0268-6186
Equus Caballus Skinhorse epitheliaEquus caballus skin .05 g/mLInjection, SolutionSubcutaneousALK-Abello, Inc.0268-0631
Populus Deltoides Pollencottonwood eastern commonPopulus deltoides pollen .1 g/mLInjection, SolutionSubcutaneousALK-Abello, Inc.0268-1126
Paspalum Notatum Pollenbahia grassPaspalum notatum pollen .1 g/mLInjection, SolutionSubcutaneousALK-Abello, Inc.0268-1034
AcaciaAcacia .05 g/mLInjection, SolutionPercutaneousALK-Abello, Inc.0268-6600
Ligustrum Vulgare PollenprivetLigustrum vulgare pollen .05 g/mLInjection, SolutionPercutaneousALK-Abello, Inc.0268-6656
Epicoccum NigrumEpicoccum nigrum .05 g/mLInjection, SolutionPercutaneous, SubcutaneousALK-Abello, Inc.0268-8097
Mold Mix Bepicoccum nigrum, gibberella zeae and mucor plumbeusEpicoccum nigrum .05 g/mL + 2 more ingredientsInjection, SolutionPercutaneous, SubcutaneousALK-Abello, Inc.0268-8112
Carya Ovata Pollenshagbark hickoryCarya ovata pollen .05 g/mLInjection, SolutionPercutaneousALK-Abello, Inc.0268-6627
Maple Mixacer negundo pollen and acer rubrum pollenAcer negundo pollen .05 g/mL; Acer rubrum pollen .05 g/mLInjection, SolutionPercutaneousALK-Abello, Inc.0268-8032
Populus Deltoides Pollencottonwood eastern commonPopulus deltoides pollen .05 g/mLInjection, SolutionSubcutaneousALK-Abello, Inc.0268-1127

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