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 DirectoryProduct NDC (as listed)70771-1325Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70771-1325Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70771-1325-0 | 7077113250070771132500 | 1000 TABLET in 1 BOTTLE (70771-1325-0)Marketed from Apr 14, 2018 | |
| 70771-1325-1 | 7077113250170771132501 | 100 TABLET in 1 BOTTLE (70771-1325-1)Marketed from Apr 14, 2018 | |
| 70771-1325-3 | 7077113250370771132503 | 30 TABLET in 1 BOTTLE (70771-1325-3)Marketed from Apr 14, 2018 | |
| 70771-1325-4 | 7077113250470771132504 | 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 | 7077113250970771132509 | 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 LimitedNDC labeler code 70771
- 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 0J48LPH2TH, R85M2X0D68
- 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 .
About NDC 70771-1325
- What is NDC 70771-1325?
- 70771-1325 is the product NDC for candesartan cilexetil and hydrochlorothiazide, Candesartan cilexetil 16 mg/1; Hydrochlorothiazide 12.5 mg/1 tablet, listed with the FDA by Zydus Lifesciences Limited. It has 5 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- candesartan cilexetil and hydrochlorothiazide.
- What is the active ingredient?
- Candesartan cilexetil, Hydrochlorothiazide.
- Who is the labeler?
- Zydus Lifesciences Limited, NDC labeler code 70771. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for candesartan cilexetil and hydrochlorothiazide?
- 12 other product NDCs are listed under this name. See all candesartan cilexetil 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 candesartan cilexetil 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) |
|---|---|---|---|---|---|
| Candesartan Cilexetil and Hydrochlorothiazide | Candesartan cilexetil 16 mg/1; Hydrochlorothiazide 12.5 mg/1 | TabletOral | ANI Pharmaceuticals, Inc. | 62559-660 | 62559-0660-90 |
| Candesartan Cilexetil and Hydrochlorothiazide | Candesartan cilexetil 32 mg/1; Hydrochlorothiazide 12.5 mg/1 | TabletOral | ANI Pharmaceuticals, Inc. | 62559-661 | 62559-0661-90 |
| Candesartan Cilexetil and Hydrochlorothiazide | Candesartan cilexetil 32 mg/1; Hydrochlorothiazide 25 mg/1 | TabletOral | ANI Pharmaceuticals, Inc. | 62559-662 | 62559-0662-90 |
| candesartan cilexetil and hydrochlorothiazide | Candesartan cilexetil 32 mg/1; Hydrochlorothiazide 12.5 mg/1 | TabletOral | Zydus Lifesciences Limited | 70771-1326 | 70771-1326-0070771-1326-0170771-1326-03+2 more |
| candesartan cilexetil and hydrochlorothiazide | Candesartan cilexetil 32 mg/1; Hydrochlorothiazide 25 mg/1 | TabletOral | Zydus Lifesciences Limited | 70771-1327 | 70771-1327-0070771-1327-0170771-1327-03+2 more |
| candesartan cilexetil and hydrochlorothiazide | Candesartan cilexetil 16 mg/1; Hydrochlorothiazide 12.5 mg/1 | TabletOral | Solco Healthcare LLC | 43547-459 | 43547-0459-0943547-0459-50 |
| candesartan cilexetil and hydrochlorothiazide | Candesartan cilexetil 32 mg/1; Hydrochlorothiazide 12.5 mg/1 | TabletOral | Solco Healthcare LLC | 43547-460 | 43547-0460-0943547-0460-50 |
| candesartan cilexetil and hydrochlorothiazide | Candesartan cilexetil 32 mg/1; Hydrochlorothiazide 25 mg/1 | TabletOral | Solco Healthcare LLC | 43547-461 | 43547-0461-0943547-0461-50 |
| Candesartan Cilexetil and Hydrochlorothiazide | Candesartan cilexetil 16 mg/1; Hydrochlorothiazide 12.5 mg/1 | TabletOral | Macleods Pharmaceuticals Limited | 33342-131 | 33342-0131-1033342-0131-1233342-0131-15+1 more |
| Candesartan Cilexetil and Hydrochlorothiazide | Candesartan cilexetil 32 mg/1; Hydrochlorothiazide 12.5 mg/1 | TabletOral | Macleods Pharmaceuticals Limited | 33342-132 | 33342-0132-1033342-0132-1233342-0132-15+1 more |
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 |