What is NDC 49643-022?

49643-022 is the product NDC for Tobacco Leaf, Tobacco leaf .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.

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 Tobacco Leaf?

5 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Tobacco Leaf NDC 49643-022 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)49643-022Labeler and product segments. Claims need a package NDC.

Product NDC at billing width49643-0022Add 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 NDC	11-digit (billing)	Package
49643-022-05	49643002205	5 mL in 1 VIAL, MULTI-DOSE (49643-022-05)Marketed from Mar 12, 1974
49643-022-10	49643002210	10 mL in 1 VIAL, MULTI-DOSE (49643-022-10)Marketed from Mar 12, 1974
49643-022-30	49643002230	30 mL in 1 VIAL, MULTI-DOSE (49643-022-30)Marketed from Mar 12, 1974
49643-022-50	49643002250	50 mL in 1 VIAL, MULTI-DOSE (49643-022-50)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): Tobacco Leaf
Generic name (nonproprietary): tobacco leaf
Active ingredients: Tobacco leaf — .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: Mar 12, 1974
Listing expires: Dec 31, 2026
Other FDA classes: Allergens (Chemical structure)Cell-mediated Immunity (Physiologic effect)Increased Histamine Release (Physiologic effect)Increased IgG Production (Physiologic effect)Plant Proteins (Chemical structure)
Identifiers: Product ID 49643-022_36ad1e17-751d-e226-e063-6394a90ab328SPL ID 36ad1e17-751d-e226-e063-6394a90ab328
Pharmacologic class: Non-Standardized Plant 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

N449643002205 followed by a unit qualifier and the quantity

Package 49643-0022-05. 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 49643-022

What is NDC 49643-022?: 49643-022 is the product NDC for Tobacco Leaf, Tobacco leaf .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?: Tobacco Leaf.
What is the active ingredient?: Tobacco leaf.
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 Tobacco Leaf?: 5 other product NDCs are listed under this name. See all Tobacco Leaf 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 Tobacco Leaf NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Tobacco, Leafnicotiana tabacum	Tobacco leaf .05 g/mL	SolutionIntradermal, Percutaneous, Subcutaneous	Greer Laboratories, Inc.	22840-5518	22840-5518-0222840-5518-05
Tobacco, Leafnicotiana tabacum	Tobacco leaf .1 g/mL	SolutionIntradermal, Percutaneous, Subcutaneous	Greer Laboratories, Inc.	22840-1540	22840-1540-0222840-1540-04
Tobacco, Leafnicotiana tabacum	Tobacco leaf 10000 [PNU]/mL	SolutionIntradermal, Percutaneous, Subcutaneous	Greer Laboratories, Inc.	22840-1542	22840-1542-02
Tobacco, Leafnicotiana tabacum	Tobacco leaf .001 g/mL	SolutionIntradermal, Percutaneous, Subcutaneous	Greer Laboratories, Inc.	22840-1543	22840-1543-01
Tobacco, Leafnicotiana tabacum	Tobacco leaf .05 g/mL	SolutionIntradermal, Percutaneous, Subcutaneous	Greer Laboratories, Inc.	22840-1560	22840-1560-02

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
Product	Strength	Form · route	Labeler	Product NDC
Cladosporium cladosporioides	Cladosporium cladosporioides .1 g/mL	LiquidPercutaneous, Subcutaneous	Allermed Laboratories, Inc.	49643-178
Smut, Oatustilago avenae	Ustilago avenae .05 g/mL	LiquidPercutaneous, Subcutaneous	Allermed Laboratories, Inc.	49643-176
Smut, Wheatustilago tritici	Ustilago tritici .033 g/mL	LiquidPercutaneous, Subcutaneous	Allermed Laboratories, Inc.	49643-177
Cockroach, Americanperiplaneta americana	Periplaneta americana .1 g/mL	InjectionCutaneous, Intradermal, Subcutaneous	Allermed Laboratories, Inc.	49643-047
Orris Root	Iris germanica var. Florentina root .1 g/mL	InjectionCutaneous, Intradermal, Subcutaneous	Allermed Laboratories, Inc.	49643-020
Sisal	Agave sisalana fiber .1 g/mL	InjectionCutaneous, Intradermal, Subcutaneous	Allermed Laboratories, Inc.	49643-021
Candidacandida albicans	Candida albicans .05 g/mL	InjectionCutaneous, Intradermal, Subcutaneous	Allermed Laboratories, Inc.	49643-105
Cockroach, Germanblattella germanica	Blattella germanica .1 g/mL	InjectionCutaneous, Intradermal, Subcutaneous	Allermed Laboratories, Inc.	49643-048
Alternariaalternaria alternata	Alternaria alternata .1 g/mL	InjectionCutaneous, Intradermal, Subcutaneous	Allermed Laboratories, Inc.	49643-101
Botrytisbotrytis cinerea	Botrytis cinerea .1 g/mL	InjectionCutaneous, Intradermal, Subcutaneous	Allermed Laboratories, Inc.	49643-104
Cladosporiumcladosporium herbarum	Cladosporium herbarum .1 g/mL	InjectionCutaneous, Intradermal, Subcutaneous	Allermed Laboratories, Inc.	49643-108
Cephalosporiumcephalosporium roseum	Cephalosporium roseum .1 g/mL	InjectionCutaneous, Intradermal, Subcutaneous	Allermed Laboratories, Inc.	49643-106
Chaetomiumchaetomium globosum	Chaetomium globosum .1 g/mL	InjectionCutaneous, Intradermal, Subcutaneous	Allermed Laboratories, Inc.	49643-107
Helminthosporium sativum	Cochliobolus sativus .1 g/mL	InjectionCutaneous, Intradermal, Subcutaneous	Allermed Laboratories, Inc.	49643-112
Curvulariacurvularia lunata	Cochliobolus lunatus .1 g/mL	InjectionCutaneous, Intradermal, Subcutaneous	Allermed Laboratories, Inc.	49643-109
Epicoccumepicoccum nigrum	Epicoccum nigrum .1 g/mL	InjectionCutaneous, Intradermal, Subcutaneous	Allermed Laboratories, Inc.	49643-110
Fusariumfusarium solani	Haematonectria haematococca .1 g/mL	InjectionCutaneous, Intradermal, Subcutaneous	Allermed Laboratories, Inc.	49643-111
Moniliamonilia sitophila	Chrysonilia sitophila .1 g/mL	InjectionCutaneous, Intradermal, Subcutaneous	Allermed Laboratories, Inc.	49643-113
Mucormucor racemosus	Mucor racemosus .1 g/mL	InjectionCutaneous, Intradermal, Subcutaneous	Allermed Laboratories, Inc.	49643-114
Penicilliumpenicillium chrysogenum	Penicillium chrysogenum var. Chrysogenum .1 g/mL	InjectionCutaneous, Intradermal, Subcutaneous	Allermed Laboratories, Inc.	49643-115

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