Prescription drug · ANDA
Valsartan and Hydrochlorothiazide NDC 68180-102
Hydrochlorothiazide 25 mg/1; Valsartan 320 mg/1 · Tablet, Film coated · Oral · Lupin Pharmaceuticals, Inc.
NDC codes
FDA NDC DirectoryProduct information
- Brand name (proprietary)
- Valsartan and Hydrochlorothiazide
- Generic name (nonproprietary)
- valsartan and hydrochlorothiazide
- Active ingredients
- Hydrochlorothiazide — 25 mg/1Valsartan — 320 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Lupin Pharmaceuticals, Inc.NDC labeler code 68180
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078946
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin 2 Receptor Antagonists (Mechanism)Increased Diuresis (Physiologic effect)Thiazides (Chemical structure)
- Identifiers
- Product ID 68180-102_537df828-cd82-4b5e-9d0d-da8bd1cfd736SPL ID 537df828-cd82-4b5e-9d0d-da8bd1cfd736SPL set ID d74a85de-5917-401a-b92d-6a95da5d30a6RxCUI 200284, 200285, 349353, 636042, 636045UNII 0J48LPH2TH, 80M03YXJ7IUPC 0368180105091, 0368180103097, 0368180104094
- 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.
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
Valsartan and hydrochlorothiazide tablet USP is the combination tablet of valsartan, an angiotensin II receptor blocker (ARB) and hydrochlorothiazide (HCTZ), a diuretic. Valsartan and hydrochlorothiazide tablet USP is indicated for the treatment of hypertension, to lower blood pressure: In patients not adequately controlled with monotherapy ( 1 ) As initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals ( 1 ) Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. Valsartan and hydrochlorothiazide tablet USP is indicated for the treatment of hypertension, to lower blood pressu…
Excerpt only. Read the full label for complete information.
About NDC 68180-102
- What is NDC 68180-102?
- 68180-102 is the product NDC for Valsartan and Hydrochlorothiazide, Hydrochlorothiazide 25 mg/1; Valsartan 320 mg/1 tablet, film coated, listed with the FDA by Lupin Pharmaceuticals, Inc..
- What drug is associated with this NDC?
- Valsartan and Hydrochlorothiazide.
- What is the active ingredient?
- Hydrochlorothiazide, Valsartan.
- Who is the labeler?
- Lupin Pharmaceuticals, Inc., NDC labeler code 68180. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Valsartan and Hydrochlorothiazide?
- 97 other product NDCs are listed under this name. See all Valsartan 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 Valsartan 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) |
|---|---|---|---|---|---|
| Valsartan And Hydrochlorothiazide | Valsartan 80 mg/1; Hydrochlorothiazide 12.5 mg/1 | Tablet, Film coatedOral | ScieGen Pharmaceuticals, INC. | 50228-147 | 50228-0147-1050228-0147-30 |
| Valsartan And Hydrochlorothiazide | Valsartan 160 mg/1; Hydrochlorothiazide 12.5 mg/1 | Tablet, Film coatedOral | ScieGen Pharmaceuticals, INC. | 50228-148 | 50228-0148-1050228-0148-30 |
| Valsartan And Hydrochlorothiazide | Valsartan 160 mg/1; Hydrochlorothiazide 25 mg/1 | Tablet, Film coatedOral | ScieGen Pharmaceuticals, INC. | 50228-149 | 50228-0149-1050228-0149-30 |
| Valsartan And Hydrochlorothiazide | Valsartan 320 mg/1; Hydrochlorothiazide 12.5 mg/1 | Tablet, Film coatedOral | ScieGen Pharmaceuticals, INC. | 50228-150 | 50228-0150-0550228-0150-30 |
| Valsartan And Hydrochlorothiazide | Valsartan 320 mg/1; Hydrochlorothiazide 25 mg/1 | Tablet, Film coatedOral | ScieGen Pharmaceuticals, INC. | 50228-151 | 50228-0151-0550228-0151-30 |
| Valsartan And Hydrochlorothiazide | Valsartan 80 mg/1; Hydrochlorothiazide 12.5 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 84677-072 | 84677-0072-90 |
| Valsartan And Hydrochlorothiazide | Valsartan 160 mg/1; Hydrochlorothiazide 12.5 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 84677-073 | 84677-0073-90 |
| Valsartan And Hydrochlorothiazide | Valsartan 160 mg/1; Hydrochlorothiazide 25 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 84677-074 | 84677-0074-90 |
| Valsartan And Hydrochlorothiazide | Valsartan 320 mg/1; Hydrochlorothiazide 12.5 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 84677-075 | 84677-0075-90 |
| Valsartan And Hydrochlorothiazide | Valsartan 320 mg/1; Hydrochlorothiazide 25 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 84677-076 | 84677-0076-90 |
Other NDCs under ANDA 078946
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 |
|---|---|---|---|---|
| Valsartan and Hydrochlorothiazide | Hydrochlorothiazide 12.5 mg/1; Valsartan 320 mg/1 | Tablet, Film coatedOral | Lupin Pharmaceuticals, Inc. | 68180-101 |
| Valsartan and Hydrochlorothiazide | Hydrochlorothiazide 12.5 mg/1; Valsartan 80 mg/1 | Tablet, Film coatedOral | Lupin Pharmaceuticals, Inc. | 68180-103 |
| Valsartan and Hydrochlorothiazide | Hydrochlorothiazide 12.5 mg/1; Valsartan 160 mg/1 | Tablet, Film coatedOral | Lupin Pharmaceuticals, Inc. | 68180-104 |
| Valsartan and Hydrochlorothiazide | Hydrochlorothiazide 25 mg/1; Valsartan 160 mg/1 | Tablet, Film coatedOral | Lupin Pharmaceuticals, Inc. | 68180-105 |
| Valsartan and Hydrochlorothiazide | Hydrochlorothiazide 12.5 mg/1; Valsartan 80 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 71205-249 |