Prescription drug · ANDA
Irbesartan and Hydrochlorothiazide NDC 63187-653
Irbesartan 150 mg/1; Hydrochlorothiazide 12.5 mg/1 · Tablet, Film coated · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63187-653-30 | 63187065330 | 30 TABLET, FILM COATED in 1 BOTTLE (63187-653-30)Marketed from Dec 1, 2018 | |
| 63187-653-60 | 63187065360 | 60 TABLET, FILM COATED in 1 BOTTLE (63187-653-60)Marketed from Dec 1, 2018 | |
| 63187-653-90 | 63187065390 | 90 TABLET, FILM COATED in 1 BOTTLE (63187-653-90)Marketed from Dec 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 LP
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202414
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin 2 Receptor Antagonists (Mechanism)Increased Diuresis (Physiologic effect)Thiazides (Chemical structure)
- Identifiers
- Product ID 63187-653_2c82bb30-406c-4b3e-9834-ed32ea065bf0SPL ID 2c82bb30-406c-4b3e-9834-ed32ea065bf0SPL set ID 97b09783-7bba-4f7a-b1b3-86ccf12c7eccRxCUI 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
N463187065330followed by a unit qualifier and the quantityPackage 63187-0653-30. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
Irbesartan and hydrochlorothiazide tablets USP are indicated for the treatment of hypertension. Irbesartan and hydrochlorothiazide tablets USP may be used in patients whose blood pressure is not adequately controlled on monotherapy. Irbesartan and hydrochlorothiazide tablets USP 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 USP 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, hear…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 202414
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 |
|---|---|---|---|---|
| Irbesartan and Hydrochlorothiazide | Irbesartan 150 mg/1; Hydrochlorothiazide 12.5 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-7468 |
| Irbesartan and Hydrochlorothiazide | Irbesartan 150 mg/1; Hydrochlorothiazide 12.5 mg/1 | Tablet, Film coatedOral | Macleods Pharmaceuticals Limited | 33342-057 |
| Irbesartan and Hydrochlorothiazide | Irbesartan 300 mg/1; Hydrochlorothiazide 12.5 mg/1 | Tablet, Film coatedOral | Macleods Pharmaceuticals Limited | 33342-058 |