NDC codes

FDA NDC Directory
Product NDC (as listed)52652-9001Labeler and product segments. Claims need a package NDC.
Product NDC at billing width52652-9001Add 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
52652-9001-152652900101473 mL in 1 BOTTLE (52652-9001-1)Marketed from Dec 6, 2021
52652-9001-2526529001021 BOTTLE in 1 CARTON (52652-9001-2) / 240 mL in 1 BOTTLEMarketed from Jan 2, 2023
52652-9001-3526529001031 BOTTLE in 1 CARTON (52652-9001-3) / 120 mL in 1 BOTTLEMarketed from Jan 2, 2023

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)
Eprontia
Generic name (nonproprietary)
topiramate
Active ingredients
Topiramate — 25 mg/mL
Dosage form
Solution
Route
Oral
Labeler
Azurity Pharmaceuticals, Inc.NDC labeler code 52652
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 214679
Marketing start
Listing expires
Other FDA classes
Cytochrome P450 2C19 Inhibitors (Mechanism)Cytochrome P450 3A4 Inducers (Mechanism)Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
Identifiers
Product ID 52652-9001_3feb6452-372c-4c60-8e91-220be75f90b1SPL ID 3feb6452-372c-4c60-8e91-220be75f90b1SPL set ID e2a4df59-fead-4a01-9021-9eda02c48010RxCUI 2586427, 2586433UNII 0H73WJJ391

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

N452652900101 followed by a unit qualifier and the quantity

Package 52652-9001-01. 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 .

Indications (excerpt from the label)

EPRONTIA is indicated for: Epilepsy: Initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older ( 1.1 ); adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome in patients 2 years of age and older ( 1.2 ). Preventive treatment of migraine in patients 12 years of age and older ( 1.3 ). 1.1 Monotherapy Epilepsy EPRONTIA is indicated as initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older. 1.2 Adjunctive Therapy Epilepsy EPRONTIA is …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 52652-9001

What is NDC 52652-9001?
52652-9001 is the product NDC for Eprontia (topiramate), Topiramate 25 mg/mL solution, listed with the FDA by Azurity Pharmaceuticals, Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Eprontia (Topiramate).
What is the active ingredient?
Topiramate.
Who is the labeler?
Azurity Pharmaceuticals, Inc., NDC labeler code 52652. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Eprontia?
None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

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