NDC codes

FDA NDC Directory
Product NDC (as listed)72865-273Labeler and product segments. Claims need a package NDC.
Product NDC at billing width72865-0273Add 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
72865-273-60728650273607286502736060 CAPSULE in 1 BOTTLE (72865-273-60)Marketed from Aug 1, 2023

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)
Dabigatran Etexilate
Generic name (nonproprietary)
dabigatran etexilate
Active ingredients
Dabigatran etexilate mesylate — 150 mg/1
Dosage form
Capsule
Route
Oral
Labeler
XLCare Pharmaceuticals, Inc.NDC labeler code 72865
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 207961
Marketing start
Listing expires
Other FDA classes
Thrombin Inhibitors (Mechanism)
Identifiers
Product ID 72865-273_3f2f2d85-443a-46a1-a637-69b106156df4SPL ID 3f2f2d85-443a-46a1-a637-69b106156df4SPL set ID 19b3bfc1-4fcb-4eb9-a611-02c27c05c56eRxCUI 1037045, 1037179UNII SC7NUW5IITUPC 0372865272602, 0372865273609
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

N472865027360 followed by a unit qualifier and the quantity

Package 72865-0273-60. 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)

Dabigatran etexilate capsules are direct thrombin inhibitors indicated: To reduce the risk of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation ( 1.1 ) For the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) in adult patients who have been treated with a parenteral anticoagulant for 5 to 10 days ( 1.2 ) To reduce the risk of recurrence of DVT and PE in adult patients who have been previously treated ( 1.3 ) 1.1 Reduction of Risk of Stroke and Systemic Embolism in Non-valvular Atrial Fibrillation in Adult Patients Dabigatran etexilate capsules are indicated to reduce the risk of stroke and systemic embolism in adult patients with non-va…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 72865-273

What is NDC 72865-273?
72865-273 is the product NDC for Dabigatran Etexilate, Dabigatran etexilate mesylate 150 mg/1 capsule, listed with the FDA by XLCare Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Dabigatran Etexilate.
What is the active ingredient?
Dabigatran etexilate mesylate.
Who is the labeler?
XLCare Pharmaceuticals, Inc., NDC labeler code 72865. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Dabigatran Etexilate?
30 other product NDCs are listed under this name. See all Dabigatran Etexilate 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 Dabigatran Etexilate NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Dabigatran EtexilateDabigatran etexilate mesylate 150 mg/1CapsuleOralNorthStar RxLLC72603-23972603-0239-01
Dabigatran EtexilateDabigatran etexilate mesylate 110 mg/1Capsule, Coated pelletsOralAscend Laboratories, LLC67877-62467877-0624-3167877-0624-60
Dabigatran EtexilateDabigatran etexilate mesylate 75 mg/1Capsule, Coated pelletsOralMajor Pharmaceuticals0904-725300904-7253-0400904-7253-68
Dabigatran EtexilateDabigatran etexilate mesylate 110 mg/1Capsule, Coated pelletsOralMajor Pharmaceuticals0904-725400904-7254-68
Dabigatran EtexilateDabigatran etexilate mesylate 150 mg/1Capsule, Coated pelletsOralMajor Pharmaceuticals0904-725500904-7255-1000904-7255-68
Dabigatran EtexilateDabigatran etexilate mesylate 75 mg/1CapsuleOralAurobindo Pharma Limited59651-97359651-0973-6059651-0973-61
Dabigatran EtexilateDabigatran etexilate mesylate 110 mg/1CapsuleOralAurobindo Pharma Limited59651-97459651-0974-6059651-0974-61
Dabigatran EtexilateDabigatran etexilate mesylate 150 mg/1CapsuleOralAurobindo Pharma Limited59651-97559651-0975-6059651-0975-61
Dabigatran etexilateDabigatran etexilate mesylate 110 mg/1CapsuleOralDr.Reddys Laboratories Inc43598-45343598-0453-60
Dabigatran etexilateDabigatran etexilate mesylate 150 mg/1CapsuleOralDr.Reddys Laboratories Inc43598-64143598-0641-60

All 31 Dabigatran Etexilate NDCs

Other NDCs under ANDA 207961

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

FDA NDC Directory listings under ANDA 207961
ProductStrengthForm · routeLabelerProduct NDC
Dabigatran EtexilateDabigatran etexilate mesylate 75 mg/1CapsuleOralCamber Pharmaceuticals, Inc.31722-621
Dabigatran EtexilateDabigatran etexilate mesylate 150 mg/1CapsuleOralCamber Pharmaceuticals, Inc.31722-622
Dabigatran EtexilateDabigatran etexilate mesylate 110 mg/1CapsuleOralCamber Pharmaceuticals, Inc.31722-666
Dabigatran EtexilateDabigatran etexilate mesylate 150 mg/1CapsuleOralNorthStar RxLLC72603-239
Dabigatran EtexilateDabigatran etexilate mesylate 75 mg/1CapsuleOralXLCare Pharmaceuticals, Inc.72865-272

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