Prescription drug · ANDA
Hydrochlorothiazide NDC 57237-002
Hydrochlorothiazide 12.5 mg/1 · Capsule · Oral · Rising Pharma Holdings, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 57237-002-01 | 57237000201 | 100 CAPSULE in 1 BOTTLE (57237-002-01)Marketed from Sep 19, 2007 | |
| 57237-002-05 | 57237000205 | 500 CAPSULE in 1 BOTTLE (57237-002-05)Marketed from Sep 19, 2007 | |
| 57237-002-99 | 57237000299 | 1000 CAPSULE in 1 BOTTLE (57237-002-99)Marketed from Sep 19, 2007 |
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 — 12.5 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Rising Pharma Holdings, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078164
- Marketing start
- Listing expires
- Other FDA classes
- Increased Diuresis (Physiologic effect)Thiazides (Chemical structure)
- Identifiers
- Product ID 57237-002_adc31708-42a5-4529-ab66-b0445d1ba5e8SPL ID adc31708-42a5-4529-ab66-b0445d1ba5e8SPL set ID 33f9c3ae-108d-469e-af6c-8be3b0f83139RxCUI 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
N457237000201followed by a unit qualifier and the quantityPackage 57237-0002-01. 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 capsules 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 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 devel…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 078164
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 | Aurobindo Pharma Limited | 65862-113 |
| Hydrochlorothiazide | Hydrochlorothiazide 12.5 mg/1 | CapsuleOral | Preferred Pharmaceuticals Inc. | 68788-8862 |
| Hydrochlorothiazide | Hydrochlorothiazide 12.5 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-0770 |