Prescription drug · ANDA
Irbesartan and Hydrochlorothiazide NDC 46708-442
Irbesartan 150 mg/1; Hydrochlorothiazide 12.5 mg/1 · Tablet · Oral · Alembic Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 46708-442-10 | 46708044210 | 10 TABLET in 1 BLISTER PACK (46708-442-10)Marketed from May 23, 2016 | |
| 46708-442-30 | 46708044230 | 30 TABLET in 1 BOTTLE (46708-442-30)Marketed from May 23, 2016 | |
| 46708-442-90 | 46708044290 | 90 TABLET in 1 BOTTLE (46708-442-90)Marketed from May 23, 2016 | |
| 46708-442-91 | 46708044291 | 1000 TABLET in 1 BOTTLE (46708-442-91)Marketed from May 23, 2016 |
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
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091370
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin 2 Receptor Antagonists (Mechanism)Increased Diuresis (Physiologic effect)Thiazides (Chemical structure)
- Identifiers
- Product ID 46708-442_bbfa2906-f126-40a2-a5c4-8cbe19388fccSPL ID bbfa2906-f126-40a2-a5c4-8cbe19388fccSPL set ID 9492a1cd-c012-4b43-931d-235220065e1eRxCUI 310792, 310793, 485471UNII 0J48LPH2TH, J0E2756Z7NUPC 0346708442309, 0346708444303, 0346708443306
- 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
N446708044210followed by a unit qualifier and the quantityPackage 46708-0442-10. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
1. INDICATIONS AND USAGE 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 stro…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 091370
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 300 mg/1; Hydrochlorothiazide 25 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-053 |
| Irbesartan and Hydrochlorothiazide | Irbesartan 300 mg/1; Hydrochlorothiazide 12.5 mg/1 | TabletOral | Alembic Pharmaceuticals Limited | 46708-443 |
| Irbesartan and Hydrochlorothiazide | Irbesartan 300 mg/1; Hydrochlorothiazide 25 mg/1 | TabletOral | Alembic Pharmaceuticals Limited | 46708-444 |
| Irbesartan and Hydrochlorothiazide | Irbesartan 150 mg/1; Hydrochlorothiazide 12.5 mg/1 | TabletOral | Alembic Pharmaceuticals Inc. | 62332-051 |
| Irbesartan and Hydrochlorothiazide | Irbesartan 300 mg/1; Hydrochlorothiazide 12.5 mg/1 | TabletOral | Alembic Pharmaceuticals Inc. | 62332-052 |