What is NDC 0904-7255?

0904-7255 is the product NDC for Dabigatran Etexilate, Dabigatran etexilate mesylate 150 mg/1 capsule, coated pellets, listed with the FDA by Major Pharmaceuticals. It has 2 package NDCs, shown above in 10- and 11-digit form.

Major Pharmaceuticals, NDC labeler code 0904. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Dabigatran Etexilate NDC 0904-7255

NDC codes

FDA NDC Directory

Product NDC (as listed)0904-7255Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00904-7255Add 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
0904-7255-10	0090472551000904725510	2 BLISTER PACK in 1 CARTON (0904-7255-10) / 10 CAPSULE, COATED PELLETS in 1 BLISTER PACK (0904-7255-35)Marketed from Jun 23, 2025
0904-7255-68	0090472556800904725568	6 BLISTER PACK in 1 CARTON (0904-7255-68) / 10 CAPSULE, COATED PELLETS in 1 BLISTER PACK (0904-7255-35)Marketed from Jun 23, 2025

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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, Coated pellets
Route: Oral
Labeler: Major PharmaceuticalsNDC labeler code 0904
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 208040
Marketing start: Jun 23, 2025
Listing expires: Dec 31, 2027
Other FDA classes: Thrombin Inhibitors (Mechanism)
Identifiers: Product ID 0904-7255_869fd2f3-9357-4148-8b64-0cca96dd5f75SPL ID 869fd2f3-9357-4148-8b64-0cca96dd5f75SPL set ID b76b79ce-b7dd-4390-b40e-71ae6c477d10RxCUI 1037045, 1037179, 1723476UNII SC7NUW5IITUPC 0309047253043, 0309047255108
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

N400904725510 followed by a unit qualifier and the quantity

Package 00904-7255-10. 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 Jun 12, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

Dabigatran Etexilate Capsules is 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 been treate…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0904-7255

What is NDC 0904-7255?: 0904-7255 is the product NDC for Dabigatran Etexilate, Dabigatran etexilate mesylate 150 mg/1 capsule, coated pellets, listed with the FDA by Major Pharmaceuticals. It has 2 package NDCs, 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?: Major Pharmaceuticals, NDC labeler code 0904. 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
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Dabigatran Etexilate	Dabigatran etexilate mesylate 150 mg/1	CapsuleOral	NorthStar RxLLC	72603-239	72603-0239-01
Dabigatran Etexilate	Dabigatran etexilate mesylate 110 mg/1	Capsule, Coated pelletsOral	Ascend Laboratories, LLC	67877-624	67877-0624-3167877-0624-60
Dabigatran Etexilate	Dabigatran etexilate mesylate 75 mg/1	Capsule, Coated pelletsOral	Major Pharmaceuticals	0904-7253	00904-7253-0400904-7253-68
Dabigatran Etexilate	Dabigatran etexilate mesylate 110 mg/1	Capsule, Coated pelletsOral	Major Pharmaceuticals	0904-7254	00904-7254-68
Dabigatran Etexilate	Dabigatran etexilate mesylate 75 mg/1	CapsuleOral	Aurobindo Pharma Limited	59651-973	59651-0973-6059651-0973-61
Dabigatran Etexilate	Dabigatran etexilate mesylate 110 mg/1	CapsuleOral	Aurobindo Pharma Limited	59651-974	59651-0974-6059651-0974-61
Dabigatran Etexilate	Dabigatran etexilate mesylate 150 mg/1	CapsuleOral	Aurobindo Pharma Limited	59651-975	59651-0975-6059651-0975-61
Dabigatran etexilate	Dabigatran etexilate mesylate 110 mg/1	CapsuleOral	Dr.Reddys Laboratories Inc	43598-453	43598-0453-60
Dabigatran etexilate	Dabigatran etexilate mesylate 150 mg/1	CapsuleOral	Dr.Reddys Laboratories Inc	43598-641	43598-0641-60
Dabigatran etexilate	Dabigatran etexilate mesylate 75 mg/1	CapsuleOral	Dr.Reddys Laboratories Inc	43598-642	43598-0642-60

All 31 Dabigatran Etexilate NDCs

Other NDCs under ANDA 208040

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

FDA NDC Directory listings under ANDA 208040
Product	Strength	Form · route	Labeler	Product NDC
Dabigatran Etexilate	Dabigatran etexilate mesylate 75 mg/1	Capsule, Coated pelletsOral	Major Pharmaceuticals	0904-7253
Dabigatran Etexilate	Dabigatran etexilate mesylate 110 mg/1	Capsule, Coated pelletsOral	Major Pharmaceuticals	0904-7254
Dabigatran Etexilate	Dabigatran etexilate mesylate 75 mg/1	Capsule, Coated pelletsOral	A-S Medication Solutions	50090-7656
Dabigatran Etexilate	Dabigatran etexilate mesylate 150 mg/1	Capsule, Coated pelletsOral	A-S Medication Solutions	50090-7657
Dabigatran Etexilate	Dabigatran etexilate mesylate 75 mg/1	Capsule, Coated pelletsOral	Ascend Laboratories, LLC	67877-474
Dabigatran Etexilate	Dabigatran etexilate mesylate 150 mg/1	Capsule, Coated pelletsOral	Ascend Laboratories, LLC	67877-475
Dabigatran Etexilate	Dabigatran etexilate mesylate 110 mg/1	Capsule, Coated pelletsOral	Ascend Laboratories, LLC	67877-624