Prescription drug · ANDA
Hydrochlorothiazide NDC 0615-8344
Hydrochlorothiazide 12.5 mg/1 · Capsule · Oral · NCS HealthCare of KY, LLC dba Vangard Labs
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0615-8344-05 | 00615834405 | 15 CAPSULE in 1 BLISTER PACK (0615-8344-05)Marketed from Jun 8, 2020 | |
| 0615-8344-39 | 00615834439 | 30 CAPSULE in 1 BLISTER PACK (0615-8344-39)Marketed from Jun 8, 2020 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 12.5 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203561
- Marketing start
- Listing expires
- Other FDA classes
- Increased Diuresis (Physiologic effect)Thiazides (Chemical structure)
- Identifiers
- Product ID 0615-8344_01e219c3-cc49-429f-8088-1c5bb66f11ceSPL ID 01e219c3-cc49-429f-8088-1c5bb66f11ceSPL set ID d6b933c6-f5f8-406a-84d6-b22c6040482aRxCUI 199903UNII 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
N400615834405followed by a unit qualifier and the quantityPackage 00615-8344-05. 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 capsules, USP are indicated in the management of hypertension either as the sole therapeutic agent, or in combination with other antihypertensives. Unlike potassium sparing combination diuretic products, hydrochlorothiazide capsules, USP may be used in those patients in whom the development of hyperkalemia cannot be risked, including patients taking ACE inhibitors. Usage in Pregnancy: The routine use of diuretics in an otherwise healthy woman is inappropriate and exposes mother and fetus to unnecessary hazard. Diuretics do not prevent development of toxemia of pregnancy, and there is no satisfactory evidence that they are useful in the treatment of d…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 203561
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 12.5 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-8498 |
| Hydrochlorothiazide | Hydrochlorothiazide 12.5 mg/1 | CapsuleOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-500 |
| Hydrochlorothiazide | Hydrochlorothiazide 12.5 mg/1 | CapsuleOral | Northwind Health Company, LLC | 51655-616 |
| Hydrochlorothiazide | Hydrochlorothiazide 12.5 mg/1 | CapsuleOral | Proficient Rx LP | 71205-980 |
| Hydrochlorothiazide | Hydrochlorothiazide 12.5 mg/1 | CapsuleOral | Bryant Ranch Prepack | 72162-1528 |
| Hydrochlorothiazide | Hydrochlorothiazide 12.5 mg/1 | CapsuleOral | Preferred Pharmaceuticals, Inc. | 68788-7683 |
| Hydrochlorothiazide | Hydrochlorothiazide 12.5 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-2550 |
| Hydrochlorothiazide | Hydrochlorothiazide 12.5 mg/1 | CapsuleOral | ScieGen Pharmaceuticals Inc | 50228-146 |
| Hydrochlorothiazide | Hydrochlorothiazide 12.5 mg/1 | CapsuleOral | PD-Rx Pharmaceuticals, Inc. | 72789-176 |
| Hydrochlorothiazide | Hydrochlorothiazide 12.5 mg/1 | CapsuleOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-697 |
| Hydrochlorothiazide | Hydrochlorothiazide 12.5 mg/1 | CapsuleOral | Westminster Pharmaceuticals, LLC | 69367-219 |
| Hydrochlorothiazide | Hydrochlorothiazide 12.5 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-1713 |
| Hydrochlorothiazide | Hydrochlorothiazide 12.5 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-6987 |
| Hydrochlorothiazide | Hydrochlorothiazide 12.5 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-6988 |
| Hydrochlorothiazide | Hydrochlorothiazide 12.5 mg/1 | CapsuleOral | AvPAK | 50268-404 |
| Hydrochlorothiazide | Hydrochlorothiazide 12.5 mg/1 | CapsuleOral | Proficient Rx LP | 71205-589 |