NDC codes

FDA NDC Directory
Product NDC (as listed)65044-9998Labeler and product segments. Claims need a package NDC.
Product NDC at billing width65044-9998Add 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
65044-9998-1650449998015 mL in 1 VIAL (65044-9998-1)Marketed from Jun 15, 1995

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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

Generic name (nonproprietary)
histamine
Active ingredients
Histamine — 6 mg/mL
Dosage form
Injection
Route
Percutaneous
Labeler
Jubilant HollisterStier LLCNDC labeler code 65044
Product type
Prescription drug
Marketing category
BLA — Biologics License ApplicationApplication BLA 103891
Marketing start
Listing expires
Identifiers
Product ID 65044-9998_2d00bd89-9169-4cb8-8685-767985bb7908SPL ID 2d00bd89-9169-4cb8-8685-767985bb7908SPL set ID 5c20f3f4-65f8-4cdb-bdd1-5774da1c551bUNII 820484N8I3

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.

NDC on a medical claim

N465044999801 followed by a unit qualifier and the quantity

Package 65044-9998-01. 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

Current FDA label (SPL), effective . This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Positive Skin Test Control - Histamine is indicated as an adjunct in allergy skin test for diagnosis, as a positive control to test wheal-flare response of skin for evaluation of skin test response to allergenic extracts.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 65044-9998

What is NDC 65044-9998?
65044-9998 is the product NDC for Positive Skin Test Control - Histamine, Histamine 6 mg/mL injection, listed with the FDA by Jubilant HollisterStier LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Positive Skin Test Control - Histamine (Histamine).
What is the active ingredient?
Histamine.
Who is the labeler?
Jubilant HollisterStier LLC, NDC labeler code 65044. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Positive Skin Test Control - Histamine?
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.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free Med-Code account to keep looking up NDCs, J-codes and drugs.

Create a free accountLog in