What is NDC 0054-0254?

0054-0254 is the product NDC for Irbesartan and Hydrochlorothiazide, Irbesartan 150 mg/1; Hydrochlorothiazide 12.5 mg/1 tablet, listed with the FDA by Hikma Pharmaceuticals USA Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.

What is the active ingredient?

Irbesartan, Hydrochlorothiazide.

Hikma Pharmaceuticals USA Inc., NDC labeler code 0054. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Irbesartan and Hydrochlorothiazide?

25 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Irbesartan and Hydrochlorothiazide NDC 0054-0254

NDC codes

FDA NDC Directory

Product NDC (as listed)0054-0254Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00054-0254Add 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
0054-0254-13	00054025413	30 TABLET in 1 BOTTLE (0054-0254-13)Marketed from Oct 15, 2012
0054-0254-22	00054025422	90 TABLET in 1 BOTTLE (0054-0254-22)Marketed from Oct 15, 2012

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): Irbesartan and Hydrochlorothiazide
Generic name (nonproprietary): irbesartan and hydrochlorothiazide
Active ingredients: Irbesartan — 150 mg/1Hydrochlorothiazide — 12.5 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Hikma Pharmaceuticals USA Inc.NDC labeler code 0054
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 090351
Marketing start: Oct 15, 2012
Listing expires: Dec 31, 2026
Other FDA classes: Angiotensin 2 Receptor Antagonists (Mechanism)Increased Diuresis (Physiologic effect)Thiazides (Chemical structure)
Identifiers: Product ID 0054-0254_73e2946e-057a-4748-ac8c-13d48bb36599SPL ID 73e2946e-057a-4748-ac8c-13d48bb36599SPL set ID 17561aae-f0bc-4ffc-a007-985b17e9baf0RxCUI 310792, 310793, 485471UNII 0J48LPH2TH, J0E2756Z7NUPC 0300540255138, 0300540255220, 0300540254131
Pharmacologic class: Angiotensin 2 Receptor Blocker; Thiazide 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

N400054025413 followed by a unit qualifier and the quantity

Package 00054-0254-13. 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 Dec 1, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

Irbesartan and hydrochlorothiazide tablets are indicated for the treatment of hypertension. Irbesartan and hydrochlorothiazide may be used in patients whose blood pressure is not adequately controlled on monotherapy. Irbesartan and hydrochlorothiazide may also be used as initial therapy in patients who are likely to need multiple drugs to achieve their blood pressure goals. The choice of irbesartan and hydrochlorothiazide as initial therapy for hypertension should be based on an assessment of potential benefits and risks. Patients with stage 2 (moderate or severe) hypertension are at relatively high risk for cardiovascular events (such as strokes, heart attacks, and heart failure), kidney fa…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0054-0254

What is NDC 0054-0254?: 0054-0254 is the product NDC for Irbesartan and Hydrochlorothiazide, Irbesartan 150 mg/1; Hydrochlorothiazide 12.5 mg/1 tablet, listed with the FDA by Hikma Pharmaceuticals USA Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Irbesartan and Hydrochlorothiazide.
What is the active ingredient?: Irbesartan, Hydrochlorothiazide.
Who is the labeler?: Hikma Pharmaceuticals USA Inc., NDC labeler code 0054. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Irbesartan and Hydrochlorothiazide?: 25 other product NDCs are listed under this name. See all Irbesartan and Hydrochlorothiazide 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 Irbesartan and Hydrochlorothiazide NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Irbesartan and Hydrochlorothiazide	Irbesartan 300 mg/1; Hydrochlorothiazide 12.5 mg/1	TabletOral	REMEDYREPACK INC.	70518-1550	70518-1550-0070518-1550-01
Irbesartan and Hydrochlorothiazide	Irbesartan 150 mg/1; Hydrochlorothiazide 12.5 mg/1	Tablet, Film coatedOral	Unichem Pharmaceuticals (USA), Inc.	29300-215	29300-0215-1029300-0215-1329300-0215-19
Irbesartan and Hydrochlorothiazide	Irbesartan 300 mg/1; Hydrochlorothiazide 12.5 mg/1	Tablet, Film coatedOral	Unichem Pharmaceuticals (USA), Inc.	29300-216	29300-0216-1029300-0216-1329300-0216-19
Irbesartan and Hydrochlorothiazide	Irbesartan 150 mg/1; Hydrochlorothiazide 12.5 mg/1	TabletOral	Alembic Pharmaceuticals Limited	46708-442	46708-0442-1046708-0442-3046708-0442-90+1 more
Irbesartan and Hydrochlorothiazide	Irbesartan 300 mg/1; Hydrochlorothiazide 12.5 mg/1	TabletOral	Alembic Pharmaceuticals Limited	46708-443	46708-0443-1046708-0443-3046708-0443-90+1 more
Irbesartan and Hydrochlorothiazide	Irbesartan 300 mg/1; Hydrochlorothiazide 25 mg/1	TabletOral	Alembic Pharmaceuticals Limited	46708-444	46708-0444-1046708-0444-3046708-0444-90+1 more
Irbesartan and Hydrochlorothiazide	Irbesartan 150 mg/1; Hydrochlorothiazide 12.5 mg/1	TabletOral	Alembic Pharmaceuticals Inc.	62332-051	62332-0051-1062332-0051-3062332-0051-90+1 more
Irbesartan and Hydrochlorothiazide	Irbesartan 300 mg/1; Hydrochlorothiazide 12.5 mg/1	TabletOral	Alembic Pharmaceuticals Inc.	62332-052	62332-0052-1062332-0052-3062332-0052-90+1 more
Irbesartan and Hydrochlorothiazide	Irbesartan 300 mg/1; Hydrochlorothiazide 25 mg/1	Tablet, Film coatedOral	Alembic Pharmaceuticals Inc.	62332-053	62332-0053-1062332-0053-3062332-0053-90+1 more
Irbesartan and Hydrochlorothiazide	Irbesartan 150 mg/1; Hydrochlorothiazide 12.5 mg/1	TabletOral	Solco Healthcare US, LLC	43547-330	43547-0330-0343547-0330-0943547-0330-50

All 26 Irbesartan and Hydrochlorothiazide NDCs

Other NDCs under ANDA 090351

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

FDA NDC Directory listings under ANDA 090351
Product	Strength	Form · route	Labeler	Product NDC
Irbesartan and Hydrochlorothiazide	Irbesartan 300 mg/1; Hydrochlorothiazide 12.5 mg/1	TabletOral	Hikma Pharmaceuticals USA Inc.	0054-0255
Irbesartan and Hydrochlorothiazide	Irbesartan 150 mg/1; Hydrochlorothiazide 12.5 mg/1	TabletOral	Bryant Ranch Prepack	71335-1787