Prescription drug · ANDA
Dabigatran Etexilate NDC 31722-622
Dabigatran etexilate mesylate 150 mg/1 · Capsule · Oral · Camber Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 31722-622-32 | 31722062232 | 10 BLISTER PACK in 1 CARTON (31722-622-32) / 6 CAPSULE in 1 BLISTER PACKMarketed from Feb 3, 2025 | |
| 31722-622-60 | 31722062260 | 60 CAPSULE in 1 BOTTLE (31722-622-60)Marketed from May 6, 2020 |
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
- Camber Pharmaceuticals, Inc.
- 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 31722-622_3b236998-0037-d34f-e063-6294a90a03f5SPL ID 3b236998-0037-d34f-e063-6294a90a03f5SPL set ID 3c24e235-218b-438e-9456-42c18ff01913RxCUI 1037045, 1037179, 1723476UNII SC7NUW5IITUPC 0331722621601, 0331722622608, 0331722666602
- 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
N431722062232followed by a unit qualifier and the quantityPackage 31722-0622-32. 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 a direct thrombin inhibitor 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 ) • For the prophylaxis of DVT and PE in adult patients who have undergone hip replacement surgery ( 1.4 ) • For the treatment of venous thromboembolic events (VTE) in pediatric patients 8 to less than 18 years of age who have …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 207961
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Dabigatran Etexilate | Dabigatran etexilate mesylate 150 mg/1 | CapsuleOral | NorthStar RxLLC | 72603-239 |
| Dabigatran Etexilate | Dabigatran etexilate mesylate 150 mg/1 | CapsuleOral | XLCare Pharmaceuticals, Inc. | 72865-273 |
| Dabigatran Etexilate | Dabigatran etexilate mesylate 75 mg/1 | CapsuleOral | XLCare Pharmaceuticals, Inc. | 72865-272 |
| Dabigatran Etexilate | Dabigatran etexilate mesylate 75 mg/1 | CapsuleOral | Camber Pharmaceuticals, Inc. | 31722-621 |
| Dabigatran Etexilate | Dabigatran etexilate mesylate 110 mg/1 | CapsuleOral | Camber Pharmaceuticals, Inc. | 31722-666 |