Prescription drug · ANDA
Spironolactone and Hydrochlorothiazide NDC 72162-1625
Spironolactone 25 mg/1; Hydrochlorothiazide 25 mg/1 · Tablet · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72162-1625-0 | 72162162500 | 1000 TABLET in 1 BOTTLE, PLASTIC (72162-1625-0)Marketed from Aug 5, 2024 | |
| 72162-1625-1 | 72162162501 | 100 TABLET in 1 BOTTLE, PLASTIC (72162-1625-1)Marketed from Aug 5, 2024 | |
| 72162-1625-3 | 72162162503 | 30 TABLET in 1 BOTTLE, PLASTIC (72162-1625-3)Marketed from Aug 5, 2024 | |
| 72162-1625-4 | 72162162504 | 1000 TABLET in 1 BOTTLE, PLASTIC (72162-1625-4)Marketed from Aug 5, 2024 | |
| 72162-1625-5 | 72162162505 | 500 TABLET in 1 BOTTLE, PLASTIC (72162-1625-5)Marketed from Aug 5, 2024 | |
| 72162-1625-6 | 72162162506 | 60 TABLET in 1 BOTTLE, PLASTIC (72162-1625-6)Marketed from Aug 5, 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)
- Spironolactone and Hydrochlorothiazide
- Generic name (nonproprietary)
- spironolactone and hydrochlorothiazide
- Active ingredients
- Spironolactone — 25 mg/1Hydrochlorothiazide — 25 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 089534
- Marketing start
- Listing expires
- Other FDA classes
- Aldosterone Antagonists (Mechanism)Increased Diuresis (Physiologic effect)Thiazides (Chemical structure)
- Identifiers
- Product ID 72162-1625_0005922c-70f2-47d8-b12e-3ab205be809dSPL ID 0005922c-70f2-47d8-b12e-3ab205be809dSPL set ID b3228678-7992-4148-b4ab-aa0d8b1b8570RxCUI 198224UNII 27O7W4T232, 0J48LPH2TH
- Pharmacologic class
- Aldosterone Antagonist; 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
N472162162500followed by a unit qualifier and the quantityPackage 72162-1625-00. 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 Spironolactone, an ingredient of spironolactone and hydrochlorothiazide tablets, has been shown to be a tumorigen in chronic toxicity studies in rats (see Precautions section). Spironolactone and hydrochlorothiazide tablets should be used only in those conditions described below. Unnecessary use of this drug should be avoided. Spironolactone and hydrochlorothiazide tablets are indicated for: Edematous conditions for patients with: Congestive heart failure: •For the management of edema and sodium retention when the patient is only partially responsive to, or is intolerant of, other therapeutic measures; •The treatment of diuretic-induced hypokalemia in patients with cong…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 089534
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 |
|---|---|---|---|---|
| Spironolactone and Hydrochlorothiazide | Spironolactone 25 mg/1; Hydrochlorothiazide 25 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-1071 |
| Spironolactone and Hydrochlorothiazide | Spironolactone 25 mg/1; Hydrochlorothiazide 25 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-1068 |
| Spironolactone and Hydrochlorothiazide | Spironolactone 25 mg/1; Hydrochlorothiazide 25 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-1069 |
| Spironolactone and Hydrochlorothiazide | Spironolactone 25 mg/1; Hydrochlorothiazide 25 mg/1 | TabletOral | Sun Pharmaceutical Industries, Inc. | 53489-144 |
| Spironolactone and Hydrochlorothiazide | Spironolactone 25 mg/1; Hydrochlorothiazide 25 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2674 |
| Spironolactone and Hydrochlorothiazide | Spironolactone 25 mg/1; Hydrochlorothiazide 25 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2202 |