Prescription drug · ANDA
Hydrochlorothiazide NDC 70518-3780
Hydrochlorothiazide 50 mg/1 · Tablet · Oral · REMEDYREPACK INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-3780-0 | 70518378000 | 90 TABLET in 1 BOTTLE, PLASTIC (70518-3780-0)Marketed from Jul 9, 2023 | |
| 70518-3780-1 | 70518378001 | 30 TABLET in 1 BLISTER PACK (70518-3780-1)Marketed from Dec 8, 2023 |
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)
- Hydrochlorothiazide
- Generic name (nonproprietary)
- hydrochlorothiazide
- Active ingredients
- Hydrochlorothiazide — 50 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- REMEDYREPACK INC.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 085182
- Marketing start
- Listing expires
- Other FDA classes
- Increased Diuresis (Physiologic effect)Thiazides (Chemical structure)
- Identifiers
- Product ID 70518-3780_348bc808-7a18-4706-e063-6294a90ab7b8SPL ID 348bc808-7a18-4706-e063-6294a90ab7b8SPL set ID 1570f1ad-8372-477f-89c3-8c9ce01e27d1RxCUI 197770UNII 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
N470518378000followed by a unit qualifier and the quantityPackage 70518-3780-00. 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 .
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 085182
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 50 mg/1 | TabletOral | Chartwell RX, LLC | 62135-449 |
| Hydrochlorothiazide | Hydrochlorothiazide 25 mg/1 | TabletOral | Chartwell RX, LLC | 62135-448 |
| Hydrochlorothiazide | Hydrochlorothiazide 12.5 mg/1 | TabletOral | Chartwell RX, LLC | 62135-738 |
| Hydrochlorothiazide | Hydrochlorothiazide 25 mg/1 | TabletOral | QPharma Inc | 42708-164 |
| Hydrochlorothiazide | Hydrochlorothiazide 12.5 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4251 |
| Hydrochlorothiazide | Hydrochlorothiazide 50 mg/1 | TabletOral | Northwind Health Company, LLC | 82868-016 |
| Hydrochlorothiazide | Hydrochlorothiazide 12.5 mg/1 | TabletOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-764 |
| Hydrochlorothiazide | Hydrochlorothiazide 25 mg/1 | TabletOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8450 |
| Hydrochlorothiazide | Hydrochlorothiazide 25 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-5211 |
| Hydrochlorothiazide | Hydrochlorothiazide 50 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4525 |
| Hydrochlorothiazide | Hydrochlorothiazide 25 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-272 |
| Hydrochlorothiazide | Hydrochlorothiazide 12.5 mg/1 | TabletOral | A-S Medication Solutions | 50090-7764 |
| Hydrochlorothiazide | Hydrochlorothiazide 12.5 mg/1 | TabletOral | A-S Medication Solutions | 50090-7765 |
| Hydrochlorothiazide | Hydrochlorothiazide 25 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4359 |
| Hydrochlorothiazide | Hydrochlorothiazide 25 mg/1 | TabletOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-008 |
| Hydrochlorothiazide | Hydrochlorothiazide 50 mg/1 | TabletOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-009 |
| Hydrochlorothiazide | Hydrochlorothiazide 50 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-7790 |
| Hydrochlorothiazide | Hydrochlorothiazide 25 mg/1 | TabletOral | Proficient Rx LP | 71205-793 |