NDC codes

FDA NDC Directory
Product NDC (as listed)49643-460Labeler and product segments. Claims need a package NDC.
Product NDC at billing width49643-0460Add 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
49643-460-0549643046005496430460055 mL in 1 VIAL, MULTI-DOSE (49643-460-05)Marketed from Mar 12, 1974
49643-460-10496430460104964304601010 mL in 1 VIAL, MULTI-DOSE (49643-460-10)Marketed from Mar 12, 1974
49643-460-30496430460304964304603030 mL in 1 VIAL, MULTI-DOSE (49643-460-30)Marketed from Mar 12, 1974
49643-460-50496430460504964304605050 mL in 1 VIAL, MULTI-DOSE (49643-460-50)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)
Linden Pollen
Generic name (nonproprietary)
tilia cordata
Active ingredients
Tilia cordata pollen — .05 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)Increased Histamine Release (Physiologic effect)Increased IgG Production (Physiologic effect)Pollen (Chemical structure)
Identifiers
Product ID 49643-460_36ad1e17-751d-e226-e063-6394a90ab328SPL ID 36ad1e17-751d-e226-e063-6394a90ab328
Pharmacologic class
Non-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.

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

N449643046005 followed by a unit qualifier and the quantity

Package 49643-0460-05. 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 49643-460

What is NDC 49643-460?
49643-460 is the product NDC for Linden Pollen (tilia cordata), Tilia cordata pollen .05 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?
Linden Pollen (Tilia cordata).
What is the active ingredient?
Tilia cordata pollen.
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 Linden Pollen?
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
Greasewood Pollensarcobatus vermiculatusSarcobatus vermiculatus pollen .05 g/mLInjectionCutaneous, Intradermal, SubcutaneousAllermed Laboratories, Inc.49643-411
Arroyo Willow Pollensalix lasiolepsisSalix lasiolepis pollen .05 g/mLInjectionCutaneous, Intradermal, SubcutaneousAllermed Laboratories, Inc.49643-408
Black Willow Pollensalix nigraSalix nigra pollen .05 g/mLInjectionCutaneous, Intradermal, SubcutaneousAllermed Laboratories, Inc.49643-409
Russian Thistle Pollensalsola kaliSalsola kali pollen .05 g/mLInjectionCutaneous, Intradermal, SubcutaneousAllermed Laboratories, Inc.49643-410
Pepper Tree Pollenschinus molleSchinus molle pollen .05 g/mLInjectionCutaneous, Intradermal, SubcutaneousAllermed Laboratories, Inc.49643-412
Johnson Grass Pollensorghum halepenseSorghum halepense pollen .05 g/mLInjectionCutaneous, Intradermal, SubcutaneousAllermed Laboratories, Inc.49643-413
Alkali Blite Pollensuaeda spp.Suaeda nigra pollen .05 g/mLInjectionCutaneous, Intradermal, SubcutaneousAllermed Laboratories, Inc.49643-414
Chinese Elm Pollenulmus pumilaUlmus pumila pollen .05 g/mLInjectionCutaneous, Intradermal, SubcutaneousAllermed Laboratories, Inc.49643-419
Salt Cedar Pollentamarix gallicaTamarix gallica pollen .05 g/mLInjectionCutaneous, Intradermal, SubcutaneousAllermed Laboratories, Inc.49643-415
Dandelion Pollentaraxacum officinaleTaraxacum officinale pollen .05 g/mLInjectionCutaneous, Intradermal, SubcutaneousAllermed Laboratories, Inc.49643-416
American Elm Pollenulmus americanaUlmus americana pollen .05 g/mLInjectionCutaneous, Intradermal, SubcutaneousAllermed Laboratories, Inc.49643-417
Red Maple Pollenacer rubrumAcer rubrum pollen .05 g/mLInjectionCutaneous, Intradermal, SubcutaneousAllermed Laboratories, Inc.49643-434
Cocklebur Pollenxanthium communeXanthium strumarium pollen .05 g/mLInjectionCutaneous, Intradermal, SubcutaneousAllermed Laboratories, Inc.49643-420
Corn Pollen Pollenzea maysZea mays pollen .05 g/mLInjectionCutaneous, Intradermal, SubcutaneousAllermed Laboratories, Inc.49643-422
Nettle Pollenurtica dioicaUrtica dioica pollen .05 g/mLInjectionCutaneous, Intradermal, SubcutaneousAllermed Laboratories, Inc.49643-423
Coast Sage Pollenartemisia californicaArtemisia californica pollen .05 g/mLInjectionCutaneous, Intradermal, SubcutaneousAllermed Laboratories, Inc.49643-437
Red Alder Pollenalnus rubraAlnus rubra pollen .05 g/mLInjectionCutaneous, Intradermal, SubcutaneousAllermed Laboratories, Inc.49643-435
Tag Alder Pollenalnus rugosaAlnus incana subsp. Rugosa pollen .05 g/mLInjectionCutaneous, Intradermal, SubcutaneousAllermed Laboratories, Inc.49643-436
Spring Birch Pollenbetula fontinalisBetula occidentalis pollen .05 g/mLInjectionCutaneous, Intradermal, SubcutaneousAllermed Laboratories, Inc.49643-441
Wing Scale Pollenatriplex canescensAtriplex canescens pollen .05 g/mLInjectionCutaneous, Intradermal, SubcutaneousAllermed Laboratories, Inc.49643-438

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