What is NDC 63187-981?

63187-981 is the product NDC for Irbesartan and Hydrochlorothiazide, Irbesartan 150 mg/1; Hydrochlorothiazide 12.5 mg/1 tablet, film coated, listed with the FDA by Proficient Rx LP. It has 3 package NDCs, shown above in 10- and 11-digit form.

What is the active ingredient?

Irbesartan, Hydrochlorothiazide.

Proficient Rx LP, NDC labeler code 63187. 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?

28 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 63187-981

NDC codes

FDA NDC Directory

Product NDC (as listed)63187-981Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63187-0981Add 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
63187-981-30	6318709813063187098130	30 TABLET, FILM COATED in 1 BOTTLE (63187-981-30)Marketed from Feb 1, 2018
63187-981-60	6318709816063187098160	60 TABLET, FILM COATED in 1 BOTTLE (63187-981-60)Marketed from Feb 1, 2018
63187-981-90	6318709819063187098190	90 TABLET, FILM COATED in 1 BOTTLE (63187-981-90)Marketed from Feb 1, 2018

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): Irbesartan and Hydrochlorothiazide
Generic name (nonproprietary): irbesartan and hydrochlorothiazide
Active ingredients: Irbesartan — 150 mg/1Hydrochlorothiazide — 12.5 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Proficient Rx LPNDC labeler code 63187
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 077369
Marketing start: Jan 24, 2013
Listing expires: Dec 31, 2027
Other FDA classes: Angiotensin 2 Receptor Antagonists (Mechanism)Increased Diuresis (Physiologic effect)Thiazides (Chemical structure)
Identifiers: Product ID 63187-981_ae512032-f396-4e77-bce4-409b8844ce3eSPL ID ae512032-f396-4e77-bce4-409b8844ce3eSPL set ID c5f26357-40f3-49f4-99f2-845a8dda5f39RxCUI 310792UNII J0E2756Z7N, 0J48LPH2TH
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

N463187098130 followed by a unit qualifier and the quantity

Package 63187-0981-30. 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 Nov 1, 2019. 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 tablets may be used in patients whose blood pressure is not adequately controlled on monotherapy. Irbesartan and hydrochlorothiazide tablets 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 tablets 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 h…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 63187-981

What is NDC 63187-981?: 63187-981 is the product NDC for Irbesartan and Hydrochlorothiazide, Irbesartan 150 mg/1; Hydrochlorothiazide 12.5 mg/1 tablet, film coated, listed with the FDA by Proficient Rx LP. It has 3 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?: Proficient Rx LP, NDC labeler code 63187. 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?: 28 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 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	Tablet, Film coatedOral	Unichem Pharmaceuticals (USA), Inc.	29300-215	29300-0215-1029300-0215-1329300-0215-19
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 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	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	Aurobindo Pharma Limited	65862-631	65862-0631-0565862-0631-3065862-0631-90+1 more

All 29 Irbesartan and Hydrochlorothiazide NDCs

Other NDCs under ANDA 077369

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

FDA NDC Directory listings under ANDA 077369
Product	Strength	Form · route	Labeler	Product NDC
Irbesartan and Hydrochlorothiazide	Irbesartan 300 mg/1; Hydrochlorothiazide 12.5 mg/1	Tablet, Film coatedOral	Teva Pharmaceuticals USA, Inc.	0093-8232
Irbesartan and Hydrochlorothiazide	Irbesartan 150 mg/1; Hydrochlorothiazide 12.5 mg/1	Tablet, Film coatedOral	Teva Pharmaceuticals USA, Inc.	0093-8238
Irbesartan and Hydrochlorothiazide	Irbesartan 150 mg/1; Hydrochlorothiazide 12.5 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-1097
Irbesartan and Hydrochlorothiazide	Irbesartan 150 mg/1; Hydrochlorothiazide 12.5 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	72162-1035