NDC codes

FDA NDC Directory
Product NDC (as listed)68084-722Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68084-0722Add 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
68084-722-65680840722656808407226550 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-722-65) / 1 TABLET, FILM COATED in 1 BLISTER PACK (68084-722-11)Marketed from Mar 19, 2014

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)
Moxifloxacin Hydrochloride
Generic name (nonproprietary)
moxifloxacin hydrochloride
Active ingredients
Moxifloxacin hydrochloride — 400 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
American Health PackagingNDC labeler code 68084
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 202632
Marketing start
Listing expires
Other FDA classes
Fluoroquinolones (Chemical structure)
Identifiers
Product ID 68084-722_55a1e3ca-d771-b7e8-e063-6294a90ac3ecSPL ID 55a1e3ca-d771-b7e8-e063-6294a90ac3ecSPL set ID 1ed191f5-7df5-488c-bb72-91ac0b618d9aRxCUI 311787UNII C53598599T

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

N468084072265 followed by a unit qualifier and the quantity

Package 68084-0722-65. 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)

Moxifloxacin tablets are a fluoroquinolone antibacterial indicated for treating infections in adults 18 years of age and older caused by designated susceptible bacteria, in the conditions listed below: Community Acquired Pneumonia (1.1) Skin and Skin Structure Infections: Uncomplicated (1.2) and Complicated (1.3) Complicated Intra-Abdominal Infections (1.4) Plague (1.5) Acute Bacterial Sinusitis (1.6) Acute Bacterial Exacerbation of Chronic Bronchitis (1.7) To reduce the development of drug-resistant bacteria and maintain the effectiveness of moxifloxacin tablets and other antibacterial drugs. Moxifloxacin tablets should be used only to treat or prevent infections that are proven or strongly…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68084-722

What is NDC 68084-722?
68084-722 is the product NDC for Moxifloxacin Hydrochloride, Moxifloxacin hydrochloride 400 mg/1 tablet, film coated, listed with the FDA by American Health Packaging. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Moxifloxacin Hydrochloride.
What is the active ingredient?
Moxifloxacin hydrochloride.
Who is the labeler?
American Health Packaging, NDC labeler code 68084. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Moxifloxacin Hydrochloride?
19 other product NDCs are listed under this name. See all Moxifloxacin Hydrochloride 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 Moxifloxacin Hydrochloride NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Moxifloxacin HydrochlorideMoxifloxacin hydrochloride 400 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-445870518-4458-00
Moxifloxacin HydrochlorideMoxifloxacin hydrochloride 5 mg/mLSolution/ dropsOphthalmicRedpharm Drug67296-223267296-2232-03
Moxifloxacin HydrochlorideMoxifloxacin hydrochloride 5 mg/mLSolution/ dropsOphthalmicSomerset Therapeutics, LLC70069-08170069-0081-01
Moxifloxacin HydrochlorideMoxifloxacin hydrochloride 400 mg/1Tablet, Film coatedOralMajor Pharmaceuticals0904-740700904-7407-0400904-7407-06
Moxifloxacin HydrochlorideMoxifloxacin hydrochloride 400 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-373870518-3738-00
Moxifloxacin HydrochlorideMoxifloxacin hydrochloride 5 mg/mLSolutionOphthalmicUpsher-Smith Laboratories, LLC0832-141000832-1410-03
Moxifloxacin HydrochlorideMoxifloxacin hydrochloride 5 mg/mLSolutionOphthalmicAsclemed USA, Inc.76420-33176420-0331-03
Moxifloxacin HydrochlorideMoxifloxacin hydrochloride 400 mg/250mLInjection, SolutionIntravenousMylan Institutional LLC67457-32367457-0323-25
Moxifloxacin HydrochlorideMoxifloxacin hydrochloride 400 mg/1Tablet, Film coatedOralAvPAK50268-57650268-0576-13
Moxifloxacin HydrochlorideMoxifloxacin hydrochloride 400 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-660950090-6609-0050090-6609-01

All 20 Moxifloxacin Hydrochloride NDCs

Other NDCs under ANDA 202632

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

FDA NDC Directory listings under ANDA 202632
ProductStrengthForm · routeLabelerProduct NDC
Moxifloxacin HydrochlorideMoxifloxacin hydrochloride 400 mg/1Tablet, Film coatedOralMajor Pharmaceuticals0904-7407
Moxifloxacin HydrochlorideMoxifloxacin hydrochloride 400 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-6609
Moxifloxacin HydrochlorideMoxifloxacin hydrochloride 400 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-7244
Moxifloxacin HydrochlorideMoxifloxacin hydrochloride 400 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-7665
Moxifloxacin HydrochlorideMoxifloxacin hydrochloride 400 mg/1Tablet, Film coatedOralAvPAK50268-576
Moxifloxacin HydrochlorideMoxifloxacin hydrochloride 400 mg/1Tablet, Film coatedOralRising Pharma Holdings, Inc.57237-156
Moxifloxacin HydrochlorideMoxifloxacin hydrochloride 400 mg/1Tablet, Film coatedOralAurobindo Pharma Limited65862-603
Moxifloxacin HydrochlorideMoxifloxacin hydrochloride 400 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-3738
Moxifloxacin HydrochlorideMoxifloxacin hydrochloride 400 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-4458
Moxifloxacin HydrochlorideMoxifloxacin hydrochloride 400 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-2329
Moxifloxacin HydrochlorideMoxifloxacin hydrochloride 400 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-2815
Moxifloxacin HydrochlorideMoxifloxacin hydrochloride 400 mg/1Tablet, Film coatedOralPD-Rx Pharmaceuticals, Inc.72789-037
Moxifloxacin HydrochlorideMoxifloxacin hydrochloride 400 mg/1Tablet, Film coatedOralPD-Rx Pharmaceuticals, Inc.72789-038
Moxifloxacin HydrochlorideMoxifloxacin hydrochloride 400 mg/1Tablet, Film coatedOralPD-Rx Pharmaceuticals, Inc.72789-350

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