Prescription drug · BLA
Positive Skin Test Control - Histamine (Histamine) NDC 65044-9998
Histamine 6 mg/mL · Injection · Percutaneous · Jubilant HollisterStier LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65044-9998-1 | 65044999801 | 5 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
- Brand name (proprietary)
- Positive Skin Test Control - Histamine
- 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
N465044999801followed by a unit qualifier and the quantityPackage 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.
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.