NDC codes

FDA NDC Directory
Product NDC (as listed)70954-041Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70954-0041Add 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
70954-041-107095400411070954004110100 CAPSULE in 1 BOTTLE (70954-041-10)Marketed from Dec 17, 2021

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)
Rifabutin
Generic name (nonproprietary)
rifabutin
Active ingredients
Rifabutin — 150 mg/1
Dosage form
Capsule
Route
Oral
Labeler
ANI Pharmaceuticals, Inc.NDC labeler code 70954
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 215041
Marketing start
Listing expires
Other FDA classes
Rifamycins (Chemical structure)
Identifiers
Product ID 70954-041_c5242fe5-fd64-4961-a19b-d9a67c9a767dSPL ID c5242fe5-fd64-4961-a19b-d9a67c9a767d
Pharmacologic class
Rifamycin Antimycobacterial

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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N470954004110 followed by a unit qualifier and the quantity

Package 70954-0041-10. 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 70954-041

What is NDC 70954-041?
70954-041 is the product NDC for Rifabutin, Rifabutin 150 mg/1 capsule, listed with the FDA by ANI Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Rifabutin.
What is the active ingredient?
Rifabutin.
Who is the labeler?
ANI Pharmaceuticals, Inc., NDC labeler code 70954. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Rifabutin?
5 other product NDCs are listed under this name. See all Rifabutin 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 Rifabutin NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
RifabutinRifabutin 150 mg/1CapsuleOrali3 Pharmaceuticals, LLC72319-01072319-0010-04
RifabutinRifabutin 150 mg/1CapsuleOralREMEDYREPACK INC.70518-459470518-4594-0070518-4594-01
RifabutinRifabutin 150 mg/1CapsuleOralREMEDYREPACK INC.70518-425470518-4254-00
RifabutinRifabutin 150 mg/1CapsuleOralMarlex Pharmaceuticals, Inc.10135-73810135-0738-01
RifabutinRifabutin 150 mg/1CapsuleOralMylan Pharmaceuticals Inc.59762-135059762-1350-01

Other NDCs under ANDA 215041

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 215041
ProductStrengthForm · routeLabelerProduct NDC
RifabutinRifabutin 150 mg/1CapsuleOralMarlex Pharmaceuticals, Inc.10135-738
RifabutinRifabutin 150 mg/1CapsuleOralREMEDYREPACK INC.70518-4594

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