Prescription drug · ANDA
Hydrochlorothiazide NDC 76282-154
Hydrochlorothiazide 25 mg/1 · Tablet · Oral · Exelan Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76282-154-01 | 76282015401 | 100 TABLET in 1 BOTTLE (76282-154-01)Marketed from Aug 30, 2016 | |
| 76282-154-05 | 76282015405 | 500 TABLET in 1 BOTTLE (76282-154-05)Marketed from Aug 30, 2016 | |
| 76282-154-10 | 76282015410 | 1000 TABLET in 1 BOTTLE (76282-154-10)Marketed from Aug 30, 2016 | |
| 76282-154-90 | 76282015490 | 90 TABLET in 1 BOTTLE (76282-154-90)Marketed from Aug 30, 2016 |
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
- Exelan Pharmaceuticals Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 040907
- Marketing start
- Listing expires
- Other FDA classes
- Increased Diuresis (Physiologic effect)Thiazides (Chemical structure)
- Identifiers
- Product ID 76282-154_3a2fd599-143e-4dc4-b22c-e08f8b16a19eSPL ID 3a2fd599-143e-4dc4-b22c-e08f8b16a19eSPL set ID b5a1b38c-0433-4649-a8b0-f72db0a96c45RxCUI 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
N476282015401followed by a unit qualifier and the quantityPackage 76282-0154-01. 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.
Other NDCs under ANDA 040907
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 | REMEDYREPACK INC. | 70518-3749 |
| Hydrochlorothiazide | Hydrochlorothiazide 50 mg/1 | TabletOral | Exelan Pharmaceuticals Inc. | 76282-155 |
| Hydrochlorothiazide | Hydrochlorothiazide 25 mg/1 | TabletOral | Unichem Pharmaceuticals (USA), Inc. | 29300-128 |
| Hydrochlorothiazide | Hydrochlorothiazide 50 mg/1 | TabletOral | Unichem Pharmaceuticals (USA), Inc. | 29300-129 |
| Hydrochlorothiazide | Hydrochlorothiazide 25 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8517 |
| Hydrochlorothiazide | Hydrochlorothiazide 50 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-303 |
| Hydrochlorothiazide | Hydrochlorothiazide 25 mg/1 | TabletOral | Unit Dose Solutions, Inc. | 87441-038 |
| Hydrochlorothiazide | Hydrochlorothiazide 12.5 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4736 |
| Hydrochlorothiazide | Hydrochlorothiazide 25 mg/1 | TabletOral | American Health Packaging | 60687-894 |
| Hydrochlorothiazide | Hydrochlorothiazide 25 mg/1 | TabletOral | Proficient Rx LP | 71205-419 |
| Hydrochlorothiazide | Hydrochlorothiazide 50 mg/1 | TabletOral | Direct_Rx | 72189-513 |
| Hydrochlorothiazide | Hydrochlorothiazide 25 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0652 |
| Hydrochlorothiazide | Hydrochlorothiazide 50 mg/1 | TabletOral | Proficient Rx LP | 82804-031 |
| Hydrochlorothiazide | Hydrochlorothiazide 25 mg/1 | TabletOral | Lake Erie Medical DBA Quality Care Products LLC | 55700-006 |
| Hydrochlorothiazide | Hydrochlorothiazide 50 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1976 |
| Hydrochlorothiazide | Hydrochlorothiazide 25 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-4933 |
| Hydrochlorothiazide | Hydrochlorothiazide 25 mg/1 | TabletOral | A-S Medication Solutions | 50090-5057 |
| Hydrochlorothiazide | Hydrochlorothiazide 25 mg/1 | TabletOral | A-S Medication Solutions | 50090-0140 |
| Hydrochlorothiazide | Hydrochlorothiazide 25 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | 60760-315 |
| Hydrochlorothiazide | Hydrochlorothiazide 25 mg/1 | TabletOral | A-S Medication Solutions | 50090-0141 |
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