Prescription drug · ANDA
candesartan cilexetil and hydrochlorothiazide NDC 70771-1325
Candesartan cilexetil 16 mg/1; Hydrochlorothiazide 12.5 mg/1 · Tablet · Oral · Zydus Lifesciences Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70771-1325-0 | 70771132500 | 1000 TABLET in 1 BOTTLE (70771-1325-0)Marketed from Apr 14, 2018 | |
| 70771-1325-1 | 70771132501 | 100 TABLET in 1 BOTTLE (70771-1325-1)Marketed from Apr 14, 2018 | |
| 70771-1325-3 | 70771132503 | 30 TABLET in 1 BOTTLE (70771-1325-3)Marketed from Apr 14, 2018 | |
| 70771-1325-4 | 70771132504 | 10 BLISTER PACK in 1 CARTON (70771-1325-4) / 10 TABLET in 1 BLISTER PACK (70771-1325-2)Marketed from Apr 14, 2018 | |
| 70771-1325-9 | 70771132509 | 90 TABLET in 1 BOTTLE (70771-1325-9)Marketed from Apr 14, 2018 |
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)
- candesartan cilexetil and hydrochlorothiazide
- Generic name (nonproprietary)
- candesartan cilexetil and hydrochlorothiazide
- Active ingredients
- Candesartan cilexetil — 16 mg/1Hydrochlorothiazide — 12.5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Zydus Lifesciences Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203466
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin 2 Receptor Antagonists (Mechanism)Increased Diuresis (Physiologic effect)Thiazides (Chemical structure)
- Identifiers
- Product ID 70771-1325_2b38d778-d732-4a7b-bb34-b426a14e10bcSPL ID 2b38d778-d732-4a7b-bb34-b426a14e10bcSPL set ID cb328bc1-5738-4620-b2b3-442e98388a86RxCUI 578325, 578330, 802749UNII R85M2X0D68, 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
N470771132500followed by a unit qualifier and the quantityPackage 70771-1325-00. 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 .
Other NDCs under ANDA 203466
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 |
|---|---|---|---|---|
| candesartan cilexetil and hydrochlorothiazide | Candesartan cilexetil 32 mg/1; Hydrochlorothiazide 12.5 mg/1 | TabletOral | Zydus Lifesciences Limited | 70771-1326 |
| candesartan cilexetil and hydrochlorothiazide | Candesartan cilexetil 32 mg/1; Hydrochlorothiazide 25 mg/1 | TabletOral | Zydus Lifesciences Limited | 70771-1327 |