NDC codes

FDA NDC Directory
Product NDC (as listed)55111-688Labeler and product segments. Claims need a package NDC.
Product NDC at billing width55111-0688Add 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
55111-688-525511106885255111068852100 mL in 1 BOTTLE, GLASS (55111-688-52)Marketed from Apr 3, 2013

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)
Zoledronic Acid
Generic name (nonproprietary)
zoledronic acid
Active ingredients
Zoledronic acid — 5 mg/100mL
Dosage form
Injection, Solution
Route
Intravenous
Labeler
Dr.Reddy's Laboratories LtdNDC labeler code 55111
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 091363
Marketing start
Listing expires
Other FDA classes
Diphosphonates (Chemical structure)
Identifiers
Product ID 55111-688_f2b67e7b-fdbb-dbab-b876-1e5bce11d057SPL ID f2b67e7b-fdbb-dbab-b876-1e5bce11d057
Pharmacologic class
Bisphosphonate

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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

Administration

Drug administration (CPT 96360–96549)

When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.

How CPT relates to drug billing

NDC on a medical claim

N455111068852 followed by a unit qualifier and the quantity

Package 55111-0688-52. 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 55111-688

What is NDC 55111-688?
55111-688 is the product NDC for Zoledronic Acid, Zoledronic acid 5 mg/100mL injection, solution, listed with the FDA by Dr.Reddy's Laboratories Ltd. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Zoledronic Acid.
What is the active ingredient?
Zoledronic acid.
Who is the labeler?
Dr.Reddy's Laboratories Ltd, NDC labeler code 55111. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Zoledronic Acid?
32 other product NDCs are listed under this name. See all Zoledronic Acid 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 Zoledronic Acid NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
zoledronic acidZoledronic acid .04 mg/mLInjection, SolutionIntravenousGland Pharma Limited68083-67268083-0672-01
Zoledronic AcidZoledronic acid 4 mg/5mLInjection, Solution, ConcentrateIntravenousBPI Labs LLC54288-18354288-0183-01
Zoledronic AcidZoledronic acid 4 mg/5mLInjection, Solution, ConcentrateIntravenousAvenacy Inc.83634-80183634-0801-05
Zoledronic acidZoledronic acid 5 mg/100mLInjectionIntravenousBluePoint Laboratories68001-61168001-0611-33
Zoledronic acidZoledronic acid 4 mg/5mLInjection, Solution, ConcentrateIntravenousBluePoint Laboratories68001-61068001-0610-25
Zoledronic AcidZoledronic acid 4 mg/5mLInjection, Solution, ConcentrateIntravenousGland Pharma Limited68083-61568083-0615-01
Zoledronic acidZoledronic acid 4 mg/5mLInjection, Solution, ConcentrateIntravenousNORTHSTAR RX LLC72603-19872603-0198-01
Zoledronic acidZoledronic acid 4 mg/5mLInjection, Solution, ConcentrateIntravenousHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.23155-17023155-0170-31
Zoledronic AcidZoledronic acid 4 mg/5mLInjection, Solution, ConcentrateIntravenousDr. Reddy's Laboratories Inc.43598-23343598-0233-11
Zoledronic acidZoledronic acid 5 mg/100mLInjectionIntravenousFOSUN PHARMA USA INC72266-15272266-0152-01

All 33 Zoledronic Acid NDCs

Other NDCs under ANDA 091363

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

FDA NDC Directory listings under ANDA 091363
ProductStrengthForm · routeLabelerProduct NDC
Zoledronic AcidZoledronic acid 5 mg/100mLInjection, SolutionIntravenousDr.Reddy's Laboratories Inc43598-331

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