Prescription drug · ANDA
Hydrochlorothiazide NDC 68071-3608
Hydrochlorothiazide 12.5 mg/1 · Tablet · Oral · NuCare Pharmaceuticals,Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68071-3608-3 | 68071360803 | 30 TABLET in 1 BOTTLE, PLASTIC (68071-3608-3)Marketed from May 15, 2024 |
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 — 12.5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- NuCare Pharmaceuticals,Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 040702
- Marketing start
- Listing expires
- Other FDA classes
- Increased Diuresis (Physiologic effect)Thiazides (Chemical structure)
- Identifiers
- Product ID 68071-3608_1884e232-bf45-68a9-e063-6394a90a87a9SPL ID 1884e232-bf45-68a9-e063-6394a90a87a9SPL set ID 1884db5f-72b5-6b0c-e063-6394a90a0e49RxCUI 429503UNII 0J48LPH2THUPC 0368071360837
- 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
N468071360803followed by a unit qualifier and the quantityPackage 68071-3608-03. 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 USP are indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Hydrochlorothiazide tablets USP 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 USP 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 a…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 040702
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 | Leading Pharma, LLC | 69315-131 |
| Hydrochlorothiazide | Hydrochlorothiazide 50 mg/1 | TabletOral | Leading Pharma, LLC | 69315-130 |
| Hydrochlorothiazide | Hydrochlorothiazide 25 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-488 |
| Hydrochlorothiazide | Hydrochlorothiazide 12.5 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 53401-038 |
| Hydrochlorothiazide | Hydrochlorothiazide 12.5 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | 60760-662 |
| Hydrochlorothiazide | Hydrochlorothiazide 12.5 mg/1 | TabletOral | A-S Medication Solutions | 50090-6372 |
| Hydrochlorothiazide | Hydrochlorothiazide 12.5 mg/1 | TabletOral | Leading Pharma, LLC | 69315-155 |
| Hydrochlorothiazide | Hydrochlorothiazide 12.5 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4466 |
| Hydrochlorothiazide | Hydrochlorothiazide 12.5 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8813 |
| Hydrochlorothiazide | Hydrochlorothiazide 12.5 mg/1 | TabletOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8449 |
| Hydrochlorothiazide | Hydrochlorothiazide 12.5 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-3652 |
| Hydrochlorothiazide | Hydrochlorothiazide 50 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 43353-240 |
| Hydrochlorothiazide | Hydrochlorothiazide 50 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-471 |
| Hydrochlorothiazide | Hydrochlorothiazide 12.5 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-674 |
| Hydrochlorothiazide | Hydrochlorothiazide 25 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-331 |
| Hydrochlorothiazide | Hydrochlorothiazide 12.5 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-330 |
| Hydrochlorothiazide | Hydrochlorothiazide 50 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-332 |
| Hydrochlorothiazide | Hydrochlorothiazide 50 mg/1 | TabletOral | Proficient Rx LP | 63187-441 |
| Hydrochlorothiazide | Hydrochlorothiazide 25 mg/1 | TabletOral | Proficient Rx LP | 63187-440 |
| Hydrochlorothiazide | Hydrochlorothiazide 12.5 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-9647 |
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