NDC codes

FDA NDC Directory
Product NDC (as listed)49643-162Labeler and product segments. Claims need a package NDC.
Product NDC at billing width49643-0162Add 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
49643-162-05496430162055 mL in 1 VIAL, MULTI-DOSE (49643-162-05)Marketed from Mar 12, 1974
49643-162-104964301621010 mL in 1 VIAL, MULTI-DOSE (49643-162-10)Marketed from Mar 12, 1974
49643-162-304964301623030 mL in 1 VIAL, MULTI-DOSE (49643-162-30)Marketed from Mar 12, 1974
49643-162-504964301625050 mL in 1 VIAL, MULTI-DOSE (49643-162-50)Marketed from Mar 12, 1974

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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)
Aspergillus niger
Generic name (nonproprietary)
aspergillus niger
Active ingredients
Aspergillus niger var. Niger — .1 g/mL
Dosage form
Liquid
Route
Percutaneous, Subcutaneous
Labeler
Allermed Laboratories, Inc.NDC labeler code 49643
Product type
Non-standardized allergenic
Marketing category
BLA — Biologics License ApplicationApplication BLA 102211
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 49643-162_36ad277a-1b95-6b09-e063-6294a90ac5a9SPL ID 36ad277a-1b95-6b09-e063-6294a90ac5a9
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

N449643016205 followed by a unit qualifier and the quantity

Package 49643-0162-05. 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 49643-162

What is NDC 49643-162?
49643-162 is the product NDC for Aspergillus niger, Aspergillus niger var. Niger .1 g/mL liquid, listed with the FDA by Allermed Laboratories, Inc.. It has 4 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Aspergillus niger.
What is the active ingredient?
Aspergillus niger var. Niger.
Who is the labeler?
Allermed Laboratories, Inc., NDC labeler code 49643. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Aspergillus niger?
5 other product NDCs are listed under this name. See all Aspergillus niger 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 Aspergillus niger NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Aspergillus nigerAspergillus niger var. Niger .05 g/mLSolutionIntradermal, Percutaneous, SubcutaneousGreer Laboratories, Inc.22840-560622840-5606-0222840-5606-0422840-5606-05
Aspergillus nigerAspergillus niger var. Niger .1 g/mLSolutionIntradermal, Percutaneous, SubcutaneousGreer Laboratories, Inc.22840-162522840-1625-0222840-1625-04
Aspergillus nigerAspergillus niger var. Niger .05 g/mLSolutionIntradermal, Percutaneous, SubcutaneousGreer Laboratories, Inc.22840-162622840-1626-04
Aspergillus nigerAspergillus niger var. Niger 20000 [PNU]/mLSolutionIntradermal, Percutaneous, SubcutaneousGreer Laboratories, Inc.22840-162722840-1627-04
Aspergillus nigerAspergillus niger var. Niger .001 g/mLSolutionIntradermal, Percutaneous, SubcutaneousGreer Laboratories, Inc.22840-162822840-1628-01

Other NDCs under BLA 102211

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

FDA NDC Directory listings under BLA 102211
ProductStrengthForm · routeLabelerProduct NDC
Beech Pollenfagus grandifoliaFagus grandifolia pollen .05 g/mLInjectionCutaneous, Intradermal, SubcutaneousAllermed Laboratories, Inc.49643-349
Russian Olive Pollenelaeagnus angustifoliaElaeagnus angustifolia pollen .05 g/mLInjectionCutaneous, Intradermal, SubcutaneousAllermed Laboratories, Inc.49643-346
Eucalyptus Polleneucalyptus globulusEucalyptus globulus pollen .05 g/mLInjectionCutaneous, Intradermal, SubcutaneousAllermed Laboratories, Inc.49643-347
Winterfat Polleneurotia lanataKrascheninnikovia lanata pollen .05 g/mLInjectionCutaneous, Intradermal, SubcutaneousAllermed Laboratories, Inc.49643-348
Iodine Bush Pollenallenrolfea occidentalisAllenrolfea occidentalis pollen .05 g/mLInjectionCutaneous, Intradermal, SubcutaneousAllermed Laboratories, Inc.49643-311
Western Wheatgrass Pollenagropyron smithiiPascopyrum smithii pollen .05 g/mLInjectionCutaneous, Intradermal, SubcutaneousAllermed Laboratories, Inc.49643-308
Tree of Heaven Pollenailanthus altissimaAilanthus altissima pollen .05 g/mLInjectionCutaneous, Intradermal, SubcutaneousAllermed Laboratories, Inc.49643-310
Redroot Pigweed Pollenamaranthus retroflexusAmaranthus retroflexus pollen .05 g/mLInjectionCutaneous, Intradermal, SubcutaneousAllermed Laboratories, Inc.49643-314
Alder, White Pollenalnus rhombifoliaAlnus rhombifolia pollen .05 g/mLInjectionCutaneous, Intradermal, SubcutaneousAllermed Laboratories, Inc.49643-312
Careless Weed Pollenamaranthus palmeriiAmaranthus palmeri pollen .05 g/mLInjectionCutaneous, Intradermal, SubcutaneousAllermed Laboratories, Inc.49643-313
Western Ragweed Pollenambrosia psilostachiaAmbrosia psilostachya pollen .05 g/mLInjectionCutaneous, Intradermal, SubcutaneousAllermed Laboratories, Inc.49643-316
Giant Ragweed Pollenambrosia trifidaAmbrosia trifida pollen .05 g/mLInjectionCutaneous, Intradermal, SubcutaneousAllermed Laboratories, Inc.49643-317
Cultivated Oat Pollenavena sativaAvena sativa pollen .05 g/mLInjectionCutaneous, Intradermal, SubcutaneousAllermed Laboratories, Inc.49643-322
Wormwood Sage Pollenartemisia absinthiumArtemisia absinthium pollen .05 g/mLInjectionCutaneous, Intradermal, SubcutaneousAllermed Laboratories, Inc.49643-319
Common Sage Pollenartemisia tridentataArtemisia tridentata pollen .05 g/mLInjectionCutaneous, Intradermal, SubcutaneousAllermed Laboratories, Inc.49643-320
Mugwort Sage Pollenartemisia vulgarisArtemisia vulgaris pollen .05 g/mLInjectionCutaneous, Intradermal, SubcutaneousAllermed Laboratories, Inc.49643-321
Sugar Beet Pollenbeta vulgarisBeta vulgaris pollen .05 g/mLInjectionCutaneous, Intradermal, SubcutaneousAllermed Laboratories, Inc.49643-324
Bassia Pollenbassia hyssopifoliaBassia hyssopifolia pollen .05 g/mLInjectionCutaneous, Intradermal, SubcutaneousAllermed Laboratories, Inc.49643-323
Smooth Brome Pollenbromus inermisBromus inermis pollen .05 g/mLInjectionCutaneous, Intradermal, SubcutaneousAllermed Laboratories, Inc.49643-328
Gray (White) Birch Pollenbetula populifoliaBetula populifolia pollen .05 g/mLInjectionCutaneous, Intradermal, SubcutaneousAllermed Laboratories, Inc.49643-325

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