Prescription drug · ANDA
Irbesartan and Hydrochlorothiazide NDC 70518-1550
Irbesartan 300 mg/1; Hydrochlorothiazide 12.5 mg/1 · Tablet · Oral · REMEDYREPACK INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-1550-0 | 7051815500070518155000 | 90 TABLET in 1 BOTTLE, PLASTIC (70518-1550-0)Marketed from Oct 18, 2018 | |
| 70518-1550-1 | 7051815500170518155001 | 90 TABLET in 1 BOTTLE, PLASTIC (70518-1550-1)Marketed from Aug 27, 2025 |
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 — 300 mg/1Hydrochlorothiazide — 12.5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- REMEDYREPACK INC.NDC labeler code 70518
- 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 70518-1550_560707e9-e7a1-7f5e-e063-6294a90a4f07SPL ID 560707e9-e7a1-7f5e-e063-6294a90a4f07SPL set ID 88aaa2a1-13be-4f56-ace6-66e899028007RxCUI 310793UNII 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
N470518155000followed by a unit qualifier and the quantityPackage 70518-1550-00. 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.
About NDC 70518-1550
- What is NDC 70518-1550?
- 70518-1550 is the product NDC for Irbesartan and Hydrochlorothiazide, Irbesartan 300 mg/1; Hydrochlorothiazide 12.5 mg/1 tablet, listed with the FDA by REMEDYREPACK 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?
- REMEDYREPACK INC., NDC labeler code 70518. 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.
Related NDCs: other Irbesartan and Hydrochlorothiazide products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| 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 |
| Irbesartan and Hydrochlorothiazide | Irbesartan 150 mg/1; Hydrochlorothiazide 12.5 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2317 | 72162-2317-0372162-2317-09 |
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 | 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 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 | 71335-2099 |
| Irbesartan and Hydrochlorothiazide | Irbesartan 150 mg/1; Hydrochlorothiazide 12.5 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2317 |