Edarbyclor NDC 60631-412

NDC codes

FDA NDC Directory

Product NDC (as listed)60631-412Labeler and product segments. Claims need a package NDC.

Product NDC at billing width60631-0412Add 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
60631-412-30	60631041230	30 TABLET in 1 BOTTLE (60631-412-30)Marketed from Feb 1, 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): Edarbyclor
Generic name (nonproprietary): azilsartan kamedoxomil and chlorthalidone
Active ingredients: Azilsartan kamedoxomil — 40 mg/1Chlorthalidone — 12.5 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals)
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 202331
Marketing start: Feb 1, 2013
Listing expires: Dec 31, 2026
Other FDA classes: Angiotensin 2 Type 1 Receptor Antagonists (Mechanism)Decreased Blood Pressure (Physiologic effect)Increased Diuresis (Physiologic effect)
Identifiers: Product ID 60631-412_26b92714-c5ea-943d-e063-6394a90a8341SPL ID 26b92714-c5ea-943d-e063-6394a90a8341SPL set ID e60f795b-fce3-4361-aa03-f143451689d1RxCUI 1235144, 1235150, 1235151, 1235157UNII Q0MQD1073Q
Pharmacologic class: Angiotensin 2 Receptor Blocker; Thiazide-like Diuretic

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

N460631041230 followed by a unit qualifier and the quantity

Package 60631-0412-30. 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 Jul 1, 2022. This label includes a boxed warning.

Indications (excerpt from the label)

Edarbyclor is indicated for the treatment of hypertension, to lower blood pressure. Edarbyclor may be used in patients whose blood pressure is not adequately controlled on monotherapy. Edarbyclor may be used as initial therapy if a patient is likely to need multiple drugs to achieve blood pressure goals. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including thiazide-like diuretics such as chlorthalidone and ARBs such as azilsartan medoxomil. There are no controlled trials demonstrating…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 202331

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

FDA NDC Directory listings under NDA 202331
Product	Strength	Form · route	Labeler	Product NDC
Edarbyclorazilsartan kamedoxomil and chlorthalidone	Azilsartan kamedoxomil 40 mg/1; Chlorthalidone 25 mg/1	TabletOral	Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals)	60631-425