NDC codes

FDA NDC Directory
Product NDC (as listed)70518-1735Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70518-1735Add 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
70518-1735-0705181735007051817350010 mL in 1 BOTTLE, PLASTIC (70518-1735-0)Marketed from Dec 14, 2018

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)
Polymyxin B Sulfate and Trimethoprim
Generic name (nonproprietary)
polymyxin b sulfate and trimethoprim
Active ingredients
Polymyxin b sulfate — 10000 [USP'U]/mLTrimethoprim sulfate — 1 mg/mL
Dosage form
Solution
Route
Ophthalmic
Labeler
REMEDYREPACK INC.NDC labeler code 70518
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 064211
Marketing start
Listing expires
Other FDA classes
Cytochrome P450 2C8 Inhibitors (Mechanism)Dihydrofolate Reductase Inhibitors (Mechanism)Organic Cation Transporter 2 Inhibitors (Mechanism)Polymyxins (Chemical structure)
Identifiers
Product ID 70518-1735_49626196-7f03-d41b-e063-6294a90a3bfcSPL ID 49626196-7f03-d41b-e063-6294a90a3bfcSPL set ID 2a040ba4-54bd-41e4-b519-01ca6a59658fRxCUI 244967UNII 19371312D4, E377MF8EQ8
Pharmacologic class
Dihydrofolate Reductase Inhibitor Antibacterial; Polymyxin-class 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. Ophthalmic products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N470518173500 followed by a unit qualifier and the quantity

Package 70518-1735-00. 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 .

Indications (excerpt from the label)

INDICATIONS AND USAGE Polymyxin B Sulfate and Trimethoprim Ophthalmic Solution is indicated in the treatment of surface ocular bacterial infections, including acute bacterial conjunctivitis, and blepharoconjunctivitis, caused by susceptible strains of the following microorganisms: Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pneumoniae, Streptococcus viridans, Haemophilus influenzae and Pseudomonas aeruginosa. * *Efficacy for this organism in this organ system was studied in fewer than 10 infections.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 70518-1735

What is NDC 70518-1735?
70518-1735 is the product NDC for Polymyxin B Sulfate and Trimethoprim, Polymyxin b sulfate 10000 [USP'U]/mL; Trimethoprim sulfate 1 mg/mL solution, listed with the FDA by REMEDYREPACK INC.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Polymyxin B Sulfate and Trimethoprim.
What is the active ingredient?
Polymyxin b sulfate, Trimethoprim sulfate.
Who is the labeler?
REMEDYREPACK INC., NDC labeler code 70518. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Polymyxin B Sulfate and Trimethoprim?
10 other product NDCs are listed under this name. See all Polymyxin B Sulfate and 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 Polymyxin B Sulfate and Trimethoprim NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Polymyxin B Sulfate and Trimethoprimpolymyxin b sulfate and trimethoprim sulfatePolymyxin b sulfate 10000 [USP'U]/mL; Trimethoprim sulfate 1 mg/mLSolution/ dropsOphthalmicPreferred Pharmaceuticals Inc.68788-815268788-8152-01
Polymyxin B Sulfate and TrimethoprimPolymyxin b sulfate 10000 [USP'U]/mL; Trimethoprim sulfate 1 mg/mLSolutionOphthalmicPreferred Pharmacetucials Inc.68788-692768788-6927-01
Polymyxin B Sulfate and TrimethoprimPolymyxin b sulfate 10000 [USP'U]/mL; Trimethoprim sulfate 1 mg/mLSolutionOphthalmicA-S Medication Solutions50090-292550090-2925-00
Polymyxin B Sulfate and TrimethoprimPolymyxin b sulfate 10000 [USP'U]/mL; Trimethoprim sulfate 1 mg/mLSolutionOphthalmicSandoz Inc61314-62861314-0628-10
Polymyxin B Sulfate and TrimethoprimPolymyxin b sulfate 10000 [USP'U]/mL; Trimethoprim sulfate 1 mg/mLSolutionOphthalmicProficient Rx LP63187-83463187-0834-10
Polymyxin B Sulfate and TrimethoprimTrimethoprim sulfate 1 mg/mL; Polymyxin b sulfate 10000 [USP'U]/mLSolutionOphthalmicNuCare Pharmaceuticals,Inc.68071-410368071-4103-05
Polymyxin B Sulfate and Trimethoprimpolymyxin b sulfate and trimethoprim sulfatePolymyxin b sulfate 10000 [USP'U]/mL; Trimethoprim sulfate 1 mg/mLSolution/ dropsOphthalmicBausch & Lomb Incorporated24208-31524208-0315-10
Polymyxin B Sulfate and Trimethoprimpolymyxin b sulfate and trimethoprim sulfatePolymyxin b sulfate 10000 [USP'U]/mL; Trimethoprim sulfate 1 mg/mLSolution/ dropsOphthalmicProficient Rx LP63187-63163187-0631-10
Polymyxin B Sulfate and Trimethoprimpolymyxin b sulfate and trimethoprim sulfatePolymyxin b sulfate 10000 [USP'U]/mL; Trimethoprim sulfate 1 mg/mLSolution/ dropsOphthalmicNuCare Pharmaceuticals,Inc.68071-165168071-1651-05
Polymyxin B Sulfate and Trimethoprimpolymyxin b sulfate and trimethoprim sulfatePolymyxin b sulfate 10000 [USP'U]/mL; Trimethoprim sulfate 1 mg/mLSolution/ dropsOphthalmicSportpharm LLC85766-14185766-0141-10

Other NDCs under ANDA 064211

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

FDA NDC Directory listings under ANDA 064211
ProductStrengthForm · routeLabelerProduct NDC
Polymyxin B Sulfate and TrimethoprimPolymyxin b sulfate 10000 [USP'U]/mL; Trimethoprim sulfate 1 mg/mLSolutionOphthalmicA-S Medication Solutions50090-2925
Polymyxin B Sulfate and TrimethoprimPolymyxin b sulfate 10000 [USP'U]/mL; Trimethoprim sulfate 1 mg/mLSolutionOphthalmicSandoz Inc61314-628
Polymyxin B Sulfate and TrimethoprimPolymyxin b sulfate 10000 [USP'U]/mL; Trimethoprim sulfate 1 mg/mLSolutionOphthalmicProficient Rx LP63187-834
Polymyxin B Sulfate and TrimethoprimTrimethoprim sulfate 1 mg/mL; Polymyxin b sulfate 10000 [USP'U]/mLSolutionOphthalmicNuCare Pharmaceuticals,Inc.68071-4103
Polymyxin B Sulfate and TrimethoprimPolymyxin b sulfate 10000 [USP'U]/mL; Trimethoprim sulfate 1 mg/mLSolutionOphthalmicPreferred Pharmacetucials Inc.68788-6927

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