NDC codes

FDA NDC Directory
Product NDC (as listed)49643-106Labeler and product segments. Claims need a package NDC.
Product NDC at billing width49643-0106Add 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
49643-106-05496430106055 mL in 1 VIAL, MULTI-DOSE (49643-106-05)Marketed from Mar 12, 1974
49643-106-104964301061010 mL in 1 VIAL, MULTI-DOSE (49643-106-10)Marketed from Mar 12, 1974
49643-106-304964301063030 mL in 1 VIAL, MULTI-DOSE (49643-106-30)Marketed from Mar 12, 1974
49643-106-504964301065050 mL in 1 VIAL, MULTI-DOSE (49643-106-50)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)
Cephalosporium
Generic name (nonproprietary)
cephalosporium roseum
Active ingredients
Cephalosporium roseum — .1 g/mL
Dosage form
Injection
Route
Cutaneous, Intradermal, 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 49643-106_36ad1e17-751d-e226-e063-6394a90ab328SPL ID 36ad1e17-751d-e226-e063-6394a90ab328
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

N449643010605 followed by a unit qualifier and the quantity

Package 49643-0106-05. 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 49643-106

What is NDC 49643-106?
49643-106 is the product NDC for Cephalosporium (cephalosporium roseum), Cephalosporium roseum .1 g/mL injection, 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?
Cephalosporium (Cephalosporium roseum).
What is the active ingredient?
Cephalosporium roseum.
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 Cephalosporium?
None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

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
Cladosporium cladosporioidesCladosporium cladosporioides .1 g/mLLiquidPercutaneous, SubcutaneousAllermed Laboratories, Inc.49643-178
Smut, Oatustilago avenaeUstilago avenae .05 g/mLLiquidPercutaneous, SubcutaneousAllermed Laboratories, Inc.49643-176
Smut, Wheatustilago triticiUstilago tritici .033 g/mLLiquidPercutaneous, SubcutaneousAllermed Laboratories, Inc.49643-177
Cockroach, Americanperiplaneta americanaPeriplaneta americana .1 g/mLInjectionCutaneous, Intradermal, SubcutaneousAllermed Laboratories, Inc.49643-047
Orris RootIris germanica var. Florentina root .1 g/mLInjectionCutaneous, Intradermal, SubcutaneousAllermed Laboratories, Inc.49643-020
SisalAgave sisalana fiber .1 g/mLInjectionCutaneous, Intradermal, SubcutaneousAllermed Laboratories, Inc.49643-021
Tobacco LeafTobacco leaf .1 g/mLInjectionCutaneous, Intradermal, SubcutaneousAllermed Laboratories, Inc.49643-022
Candidacandida albicansCandida albicans .05 g/mLInjectionCutaneous, Intradermal, SubcutaneousAllermed Laboratories, Inc.49643-105
Cockroach, Germanblattella germanicaBlattella germanica .1 g/mLInjectionCutaneous, Intradermal, SubcutaneousAllermed Laboratories, Inc.49643-048
Alternariaalternaria alternataAlternaria alternata .1 g/mLInjectionCutaneous, Intradermal, SubcutaneousAllermed Laboratories, Inc.49643-101
Botrytisbotrytis cinereaBotrytis cinerea .1 g/mLInjectionCutaneous, Intradermal, SubcutaneousAllermed Laboratories, Inc.49643-104
Cladosporiumcladosporium herbarumCladosporium herbarum .1 g/mLInjectionCutaneous, Intradermal, SubcutaneousAllermed Laboratories, Inc.49643-108
Chaetomiumchaetomium globosumChaetomium globosum .1 g/mLInjectionCutaneous, Intradermal, SubcutaneousAllermed Laboratories, Inc.49643-107
Helminthosporium sativumCochliobolus sativus .1 g/mLInjectionCutaneous, Intradermal, SubcutaneousAllermed Laboratories, Inc.49643-112
Curvulariacurvularia lunataCochliobolus lunatus .1 g/mLInjectionCutaneous, Intradermal, SubcutaneousAllermed Laboratories, Inc.49643-109
Epicoccumepicoccum nigrumEpicoccum nigrum .1 g/mLInjectionCutaneous, Intradermal, SubcutaneousAllermed Laboratories, Inc.49643-110
Fusariumfusarium solaniHaematonectria haematococca .1 g/mLInjectionCutaneous, Intradermal, SubcutaneousAllermed Laboratories, Inc.49643-111
Moniliamonilia sitophilaChrysonilia sitophila .1 g/mLInjectionCutaneous, Intradermal, SubcutaneousAllermed Laboratories, Inc.49643-113
Mucormucor racemosusMucor racemosus .1 g/mLInjectionCutaneous, Intradermal, SubcutaneousAllermed Laboratories, Inc.49643-114
Penicilliumpenicillium chrysogenumPenicillium chrysogenum var. Chrysogenum .1 g/mLInjectionCutaneous, Intradermal, SubcutaneousAllermed Laboratories, Inc.49643-115

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