What is NDC 70954-541?

70954-541 is the product NDC for Trimethoprim, Trimethoprim 100 mg/1 tablet, listed with the FDA by Novitium Pharma LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Novitium Pharma LLC, 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 Trimethoprim?

4 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Trimethoprim NDC 70954-541 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)70954-541Labeler and product segments. Claims need a package NDC.

Product NDC at billing width70954-0541Add 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
70954-541-10	70954054110	100 TABLET in 1 BOTTLE, PLASTIC (70954-541-10)Marketed from Nov 4, 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): Trimethoprim
Generic name (nonproprietary): trimethoprim
Active ingredients: Trimethoprim — 100 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Novitium Pharma LLCNDC labeler code 70954
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 216393
Marketing start: Nov 4, 2022
Listing expires: Dec 31, 2026
Other FDA classes: Cytochrome P450 2C8 Inhibitors (Mechanism)Dihydrofolate Reductase Inhibitors (Mechanism)Organic Cation Transporter 2 Inhibitors (Mechanism)
Identifiers: Product ID 70954-541_95a1572c-6109-4d1f-bf92-262015a7654eSPL ID 95a1572c-6109-4d1f-bf92-262015a7654eSPL set ID 95a1572c-6109-4d1f-bf92-262015a7654eRxCUI 198332UNII AN164J8Y0XUPC 0370954541103
Pharmacologic class: Dihydrofolate Reductase Inhibitor Antibacterial

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

N470954054110 followed by a unit qualifier and the quantity

Package 70954-0541-10. 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

Current FDA label (SPL), effective Aug 2, 2022.

Indications (excerpt from the label)

INDICATIONS & USAGE To reduce the development of drug-resistant bacteria and maintain the effectiveness of trimethoprim tablets and other antibacterial drugs, trimethoprim tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. For the treatment of initial episodes of uncomplicated urinary tract infections due to susceptible strains of the following organis…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 70954-541

What is NDC 70954-541?: 70954-541 is the product NDC for Trimethoprim, Trimethoprim 100 mg/1 tablet, listed with the FDA by Novitium Pharma LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Trimethoprim.
What is the active ingredient?: Trimethoprim.
Who is the labeler?: Novitium Pharma LLC, 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 Trimethoprim?: 4 other product NDCs are listed under this name. See all Trimethoprim 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 Trimethoprim NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Trimethoprim	Trimethoprim 100 mg/1	TabletOral	Dr. Reddy's Labratories Inc.	75907-043	75907-0043-01
Trimethoprim	Trimethoprim 100 mg/1	TabletOral	Golden State Medical Supply, Inc.	51407-738	51407-0738-01
Trimethoprim	Trimethoprim 100 mg/1	TabletOral	Novel Laboratories, Inc.	40032-330	40032-0330-24
Trimethoprim	Trimethoprim 100 mg/1	TabletOral	Lupin Pharmaceuticals,Inc.	43386-330	43386-0330-01

Other NDCs under ANDA 216393

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

FDA NDC Directory listings under ANDA 216393
Product	Strength	Form · route	Labeler	Product NDC
Trimethoprim	Trimethoprim 100 mg/1	TabletOral	Golden State Medical Supply, Inc.	51407-738