Prescription drug · ANDA
Hydrochlorothiazide NDC 43353-719
Hydrochlorothiazide 25 mg/1 · Tablet · Oral · Aphena Pharma Solutions - Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43353-719-15 | 4335307191543353071915 | 15 TABLET in 1 BOTTLE (43353-719-15)Marketed from Apr 13, 2011 | |
| 43353-719-30 | 4335307193043353071930 | 30 TABLET in 1 BOTTLE (43353-719-30)Marketed from Apr 13, 2011 | |
| 43353-719-45 | 4335307194543353071945 | 45 TABLET in 1 BOTTLE (43353-719-45)Marketed from Apr 13, 2011 | |
| 43353-719-53 | 4335307195343353071953 | 60 TABLET in 1 BOTTLE (43353-719-53)Marketed from Apr 13, 2011 | |
| 43353-719-60 | 4335307196043353071960 | 90 TABLET in 1 BOTTLE (43353-719-60)Marketed from Apr 13, 2011 | |
| 43353-719-65 | 4335307196543353071965 | 100 TABLET in 1 BOTTLE (43353-719-65)Marketed from Apr 13, 2011 | |
| 43353-719-73 | 4335307197343353071973 | 135 TABLET in 1 BOTTLE (43353-719-73)Marketed from Apr 13, 2011 | |
| 43353-719-80 | 4335307198043353071980 | 180 TABLET in 1 BOTTLE (43353-719-80)Marketed from Apr 13, 2011 |
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)
- Hydrochlorothiazide
- Generic name (nonproprietary)
- hydrochlorothiazide
- Active ingredients
- Hydrochlorothiazide — 25 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Aphena Pharma Solutions - Tennessee, LLCNDC labeler code 43353
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 083177
- Marketing start
- Listing expires
- Other FDA classes
- Increased Diuresis (Physiologic effect)Thiazides (Chemical structure)
- Identifiers
- Product ID 43353-719_80c4cb36-638f-4d42-aa92-c5428ba5c547SPL ID 80c4cb36-638f-4d42-aa92-c5428ba5c547SPL set ID 61487122-8a94-4ad5-a307-7893e0b7510cRxCUI 197770, 310798UNII 0J48LPH2TH
- Pharmacologic class
- 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
N443353071915followed by a unit qualifier and the quantityPackage 43353-0719-15. 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 .
Indications (excerpt from the label)
INDICATIONS AND USAGE Hydrochlorothiazide tablets are indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Hydrochlorothiazide tablets have also been found useful in edema due to various forms of renal dysfunction such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure. Hydrochlorothiazide tablets are indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effectiveness of other antihypertensive drugs in the more severe forms of hypertension. Use in Pregnancy Routine use of diuretics during normal pregnancy is inappropriate and exposes m…
Excerpt only. Read the full label for complete information.
About NDC 43353-719
- What is NDC 43353-719?
- 43353-719 is the product NDC for Hydrochlorothiazide, Hydrochlorothiazide 25 mg/1 tablet, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 8 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Hydrochlorothiazide.
- What is the active ingredient?
- Hydrochlorothiazide.
- Who is the labeler?
- Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 43353. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Hydrochlorothiazide?
- 166 other product NDCs are listed under this name. See all Hydrochlorothiazide NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other 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) |
|---|---|---|---|---|---|
| Hydrochlorothiazide | Hydrochlorothiazide 50 mg/5mL | SolutionOral | Advagen Pharma Ltd | 72888-491 | 72888-0491-01 |
| Hydrochlorothiazide | Hydrochlorothiazide 12.5 mg/1 | TabletOral | Teva Pharmaceuticals, Inc. | 0480-3444 | 00480-3444-10 |
| hydrochlorothiazide | Hydrochlorothiazide 12.5 mg/1 | CapsuleOral | Preferred Pharmaceuticals Inc. | 68788-4192 | 68788-4192-0168788-4192-0368788-4192-06+2 more |
| Hydrochlorothiazide | Hydrochlorothiazide 12.5 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4736 | 70518-4736-00 |
| Hydrochlorothiazide | Hydrochlorothiazide 25 mg/1 | TabletOral | Unit Dose Solutions, Inc. | 87441-038 | 87441-0038-01 |
| Hydrochlorothiazide | Hydrochlorothiazide 12.5 mg/1 | TabletOral | Coupler LLC | 67046-1664 | 67046-1664-03 |
| Hydrochlorothiazide | Hydrochlorothiazide 25 mg/1 | TabletOral | American Health Packaging | 60687-894 | 60687-0894-01 |
| Hydrochlorothiazide | Hydrochlorothiazide 50 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4525 | 70518-4525-00 |
| Hydrochlorothiazide | Hydrochlorothiazide 12.5 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4466 | 70518-4466-0070518-4466-01 |
| Hydrochlorothiazide | Hydrochlorothiazide 25 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4359 | 70518-4359-0070518-4359-0170518-4359-02+2 more |
Other NDCs under ANDA 083177
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 |
|---|---|---|---|---|
| Hydrochlorothiazide | Hydrochlorothiazide 25 mg/1 | TabletOral | Teva Pharmaceuticals USA, Inc. | 0172-2083 |
| Hydrochlorothiazide | Hydrochlorothiazide 50 mg/1 | TabletOral | Teva Pharmaceuticals USA, Inc. | 0172-2089 |
| Hydrochlorothiazide | Hydrochlorothiazide 12.5 mg/1 | TabletOral | Teva Pharmaceuticals USA, Inc. | 0172-3444 |
| Hydrochlorothiazide | Hydrochlorothiazide 12.5 mg/1 | TabletOral | Teva Pharmaceuticals, Inc. | 0480-3444 |
| Hydrochlorothiazide | Hydrochlorothiazide 25 mg/1 | TabletOral | QPharma, Inc. | 42708-028 |
| Hydrochlorothiazide | Hydrochlorothiazide 50 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 43353-717 |
| Hydrochlorothiazide | Hydrochlorothiazide 25 mg/1 | TabletOral | A-S Medication Solutions | 50090-6014 |
| Hydrochlorothiazide | Hydrochlorothiazide 50 mg/1 | TabletOral | A-S Medication Solutions | 50090-6532 |
| Hydrochlorothiazide | Hydrochlorothiazide 12.5 mg/1 | TabletOral | A-S Medication Solutions | 50090-7772 |
| Hydrochlorothiazide | Hydrochlorothiazide 12.5 mg/1 | TabletOral | A-S Medication Solutions | 50090-7773 |
| Hydrochlorothiazide | Hydrochlorothiazide 25 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-831 |
| Hydrochlorothiazide | Hydrochlorothiazide 25 mg/1 | TabletOral | Redpharm Drug | 67296-2280 |
| Hydrochlorothiazide | Hydrochlorothiazide 25 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-4819 |
| Hydrochlorothiazide | Hydrochlorothiazide 25 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-4963 |
| Hydrochlorothiazide | Hydrochlorothiazide 25 mg/1 | TabletOral | Legacy Pharmaceutical Packaging, LLC | 68645-510 |
| Hydrochlorothiazide | Hydrochlorothiazide 50 mg/1 | TabletOral | Proficient Rx LP | 71205-751 |
| Hydrochlorothiazide | Hydrochlorothiazide 25 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-512 |