dabigatran etexilate NDC 60505-4349

NDC codes

FDA NDC Directory

Product NDC (as listed)60505-4349Labeler and product segments. Claims need a package NDC.

Product NDC at billing width60505-4349Add 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
60505-4349-6	60505434906	60 CAPSULE in 1 BOTTLE (60505-4349-6)Marketed from Feb 13, 2024

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): dabigatran etexilate
Generic name (nonproprietary): dabigatran etexilate
Active ingredients: Dabigatran etexilate mesylate — 110 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Apotex Corp.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 208070
Marketing start: Feb 13, 2024
Listing expires: Dec 31, 2027
Other FDA classes: Thrombin Inhibitors (Mechanism)
Identifiers: Product ID 60505-4349_a6e65f41-054f-4c6a-dc8d-ec2fd71a6c79SPL ID a6e65f41-054f-4c6a-dc8d-ec2fd71a6c79SPL set ID dd47a015-ff90-d7a7-8dcb-4e6e31a68071RxCUI 1037045, 1037179, 1723476UNII SC7NUW5IITUPC 0360505434763, 0360505434862, 0360505434961
Pharmacologic class: Direct Thrombin Inhibitor

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

N460505434906 followed by a unit qualifier and the quantity

Package 60505-4349-06. 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

Label details couldn’t be retrieved right now. Open the label on DailyMed.

Other NDCs under ANDA 208070

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

FDA NDC Directory listings under ANDA 208070
Product	Strength	Form · route	Labeler	Product NDC
dabigatran etexilate	Dabigatran etexilate mesylate 75 mg/1	CapsuleOral	Apotex Corp.	60505-4347
dabigatran etexilate	Dabigatran etexilate mesylate 150 mg/1	CapsuleOral	Apotex Corp.	60505-4348