Prescription drug · ANDA
Irbesartan and Hydrochlorothiazide NDC 71335-2099
Irbesartan 150 mg/1; Hydrochlorothiazide 12.5 mg/1 · Tablet · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-2099-1 | 71335209901 | 30 TABLET in 1 BOTTLE (71335-2099-1)Marketed from Jun 6, 2022 | |
| 71335-2099-2 | 71335209902 | 90 TABLET in 1 BOTTLE (71335-2099-2)Marketed from Jun 6, 2022 | |
| 71335-2099-3 | 71335209903 | 28 TABLET in 1 BOTTLE (71335-2099-3)Marketed from Jun 6, 2022 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203072
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin 2 Receptor Antagonists (Mechanism)Increased Diuresis (Physiologic effect)Thiazides (Chemical structure)
- Identifiers
- Product ID 71335-2099_586e9bc9-79fe-4001-899d-070288858692SPL ID 586e9bc9-79fe-4001-899d-070288858692SPL set ID 85494404-484c-45a1-8487-f9eb2a76490dRxCUI 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
N471335209901followed by a unit qualifier and the quantityPackage 71335-2099-01. 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 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.
Other NDCs under ANDA 203072
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 | TabletOral | Proficient Rx LP | 71205-063 |
| Irbesartan and Hydrochlorothiazide | Irbesartan 150 mg/1; Hydrochlorothiazide 12.5 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2317 |
| Irbesartan and Hydrochlorothiazide | Irbesartan 150 mg/1; Hydrochlorothiazide 12.5 mg/1 | TabletOral | Solco Healthcare US, LLC | 43547-330 |
| Irbesartan and Hydrochlorothiazide | Irbesartan 300 mg/1; Hydrochlorothiazide 12.5 mg/1 | TabletOral | Solco Healthcare US, LLC | 43547-331 |
| Irbesartan and Hydrochlorothiazide | Irbesartan 300 mg/1; Hydrochlorothiazide 12.5 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-1550 |