Prescription drug · ANDA
losartan potassium and hydrochlorothiazide NDC 71610-671
Hydrochlorothiazide 25 mg/1; Losartan potassium 100 mg/1 · Tablet, Film coated · Oral · Aphena Pharma Solutions - Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71610-671-30 | 7161006713071610067130 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-671-30)Marketed from Nov 2, 2022 | |
| 71610-671-45 | 7161006714571610067145 | 45 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-671-45)Marketed from Nov 2, 2022 | |
| 71610-671-53 | 7161006715371610067153 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-671-53)Marketed from Nov 3, 2022 | |
| 71610-671-60 | 7161006716071610067160 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-671-60)Marketed from Nov 2, 2022 | |
| 71610-671-70 | 7161006717071610067170 | 120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-671-70)Marketed from Nov 2, 2022 | |
| 71610-671-80 | 7161006718071610067180 | 180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-671-80)Marketed from Nov 2, 2022 |
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)
- losartan potassium and hydrochlorothiazide
- Generic name (nonproprietary)
- losartan potassium and hydrochlorothiazide
- Active ingredients
- Hydrochlorothiazide — 25 mg/1Losartan potassium — 100 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Aphena Pharma Solutions - Tennessee, LLCNDC labeler code 71610
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204832
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin 2 Receptor Antagonists (Mechanism)Increased Diuresis (Physiologic effect)Thiazides (Chemical structure)
- Identifiers
- Product ID 71610-671_2d778122-9382-4e15-a927-d652112b3606SPL ID 2d778122-9382-4e15-a927-d652112b3606SPL set ID 35099fd1-1bc9-428b-9b9c-71f574cc4156RxCUI 979471UNII 0J48LPH2TH, 3ST302B24A
- 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
N471610067130followed by a unit qualifier and the quantityPackage 71610-0671-30. 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)
Losartan potassium and hydrochlorothiazide tablets are combination of losartan, an angiotensin II receptor blocker (ARB) and hydrochlorothiazide, a diuretic indicated for: 1.1 Hypertension Losartan potassium and hydrochlorothiazide tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular (CV) events, primarily strokes and myocardial infarction. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including losartan and hydrochlorothiazide. Control of high blood pressure should be part of comprehensive cardiovascular risk m…
Excerpt only. Read the full label for complete information.
About NDC 71610-671
- What is NDC 71610-671?
- 71610-671 is the product NDC for losartan potassium and hydrochlorothiazide, Hydrochlorothiazide 25 mg/1; Losartan potassium 100 mg/1 tablet, film coated, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 6 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- losartan potassium and hydrochlorothiazide.
- What is the active ingredient?
- Hydrochlorothiazide, Losartan potassium.
- Who is the labeler?
- Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 71610. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for losartan potassium and hydrochlorothiazide?
- 107 other product NDCs are listed under this name. See all losartan potassium 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 losartan potassium 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) |
|---|---|---|---|---|---|
| Losartan Potassium And Hydrochlorothiazide | Losartan potassium 50 mg/1; Hydrochlorothiazide 12.5 mg/1 | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-755 | 31722-0755-1031722-0755-3031722-0755-90 |
| Losartan Potassium And Hydrochlorothiazide | Losartan potassium 100 mg/1; Hydrochlorothiazide 12.5 mg/1 | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-756 | 31722-0756-1031722-0756-3031722-0756-90 |
| Losartan Potassium And Hydrochlorothiazide | Losartan potassium 100 mg/1; Hydrochlorothiazide 25 mg/1 | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-757 | 31722-0757-1031722-0757-3031722-0757-90 |
| Losartan Potassium and Hydrochlorothiazide | Losartan potassium 50 mg/1; Hydrochlorothiazide 12.5 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1618 | 67046-1618-03 |
| Losartan potassium and Hydrochlorothiazide | Losartan potassium 100 mg/1; Hydrochlorothiazide 12.5 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 72162-2492 | 72162-2492-0072162-2492-09 |
| Losartan Potassium and Hydrochlorothiazide | Losartan potassium 100 mg/1; Hydrochlorothiazide 25 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7821 | 50090-7821-00 |
| Losartan Potassium and Hydrochlorothiazide | Losartan potassium 100 mg/1; Hydrochlorothiazide 25 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-4447 | 50090-4447-0050090-4447-0150090-4447-02 |
| Losartan Potassium and Hydrochlorothiazide | Losartan potassium 100 mg/1; Hydrochlorothiazide 12.5 mg/1 | Tablet, Film coatedOral | NorthStar Rx LLC | 16714-224 | 16714-0224-0116714-0224-0216714-0224-03 |
| Losartan Potassium and Hydrochlorothiazide | Losartan potassium 100 mg/1; Hydrochlorothiazide 25 mg/1 | Tablet, Film coatedOral | NorthStar Rx LLC | 16714-225 | 16714-0225-0116714-0225-0216714-0225-04 |
| Losartan Potassium and Hydrochlorothiazide | Losartan potassium 50 mg/1; Hydrochlorothiazide 12.5 mg/1 | Tablet, Film coatedOral | NorthStar Rx LLC | 16714-226 | 16714-0226-0116714-0226-0216714-0226-04 |
Other NDCs under ANDA 204832
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 |
|---|---|---|---|---|
| losartan potassium and hydrochlorothiazide | Hydrochlorothiazide 12.5 mg/1; Losartan potassium 100 mg/1 | Tablet, Film coatedOral | Unichem Pharmaceuticals (USA), Inc. | 29300-191 |
| losartan potassium and hydrochlorothiazide | Hydrochlorothiazide 12.5 mg/1; Losartan potassium 50 mg/1 | Tablet, Film coatedOral | Unichem Pharmaceuticals (USA), Inc. | 29300-190 |
| losartan potassium and hydrochlorothiazide | Hydrochlorothiazide 25 mg/1; Losartan potassium 100 mg/1 | Tablet, Film coatedOral | Unichem Pharmaceuticals (USA), Inc. | 29300-192 |
| losartan potassium and hydrochlorothiazide | Hydrochlorothiazide 12.5 mg/1; Losartan potassium 100 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2827 |
| losartan potassium and hydrochlorothiazide | Hydrochlorothiazide 12.5 mg/1; Losartan potassium 100 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 72162-2461 |
| losartan potassium and hydrochlorothiazide | Hydrochlorothiazide 12.5 mg/1; Losartan potassium 50 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 72162-2462 |
| losartan potassium and hydrochlorothiazide | Hydrochlorothiazide 12.5 mg/1; Losartan potassium 100 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2662 |