What is NDC 10135-738?

10135-738 is the product NDC for Rifabutin, Rifabutin 150 mg/1 capsule, listed with the FDA by Marlex Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Marlex Pharmaceuticals, Inc., NDC labeler code 10135. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Rifabutin NDC 10135-738 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)10135-738Labeler and product segments. Claims need a package NDC.

Product NDC at billing width10135-0738Add 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	Copy
10135-738-01	1013507380110135073801	100 CAPSULE in 1 BOTTLE (10135-738-01)Marketed from May 1, 2022

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: Marlex Pharmaceuticals, Inc.NDC labeler code 10135
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 215041
Marketing start: May 1, 2022
Listing expires: Dec 31, 2026
Other FDA classes: Rifamycins (Chemical structure)
Identifiers: Product ID 10135-738_43e1cc33-400c-6f7d-e063-6394a90ab38dSPL ID 43e1cc33-400c-6f7d-e063-6394a90ab38dSPL set ID df7d4103-42e4-4e4f-e053-2a95a90a8ce8RxCUI 198200UNII 1W306TDA6S
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

N410135073801 followed by a unit qualifier and the quantity

Package 10135-0738-01. 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 Nov 18, 2025.

Indications (excerpt from the label)

INDICATIONS & USAGE Rifabutin Capsules are indicated for the prevention of disseminated Mycobacterium avium complex (MAC) disease in patients with advanced HIV infection.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 10135-738

What is NDC 10135-738?: 10135-738 is the product NDC for Rifabutin, Rifabutin 150 mg/1 capsule, listed with the FDA by Marlex 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?: Marlex Pharmaceuticals, Inc., NDC labeler code 10135. 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
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Rifabutin	Rifabutin 150 mg/1	CapsuleOral	i3 Pharmaceuticals, LLC	72319-010	72319-0010-04
Rifabutin	Rifabutin 150 mg/1	CapsuleOral	REMEDYREPACK INC.	70518-4594	70518-4594-0070518-4594-01
Rifabutin	Rifabutin 150 mg/1	CapsuleOral	REMEDYREPACK INC.	70518-4254	70518-4254-00
Rifabutin	Rifabutin 150 mg/1	CapsuleOral	ANI Pharmaceuticals, Inc.	70954-041	70954-0041-10
Rifabutin	Rifabutin 150 mg/1	CapsuleOral	Mylan Pharmaceuticals Inc.	59762-1350	59762-1350-01

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
Product	Strength	Form · route	Labeler	Product NDC
Rifabutin	Rifabutin 150 mg/1	CapsuleOral	REMEDYREPACK INC.	70518-4594
Rifabutin	Rifabutin 150 mg/1	CapsuleOral	ANI Pharmaceuticals, Inc.	70954-041