Prescription drug · ANDA
Hydrochlorothiazide NDC 69584-361
Hydrochlorothiazide 25 mg/1 · Tablet · Oral · Oxford Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69584-361-10 | 69584036110 | 100 TABLET in 1 BOTTLE (69584-361-10)Marketed from Sep 25, 2020 | |
| 69584-361-90 | 69584036190 | 1000 TABLET in 1 BOTTLE (69584-361-90)Marketed from Sep 25, 2020 | |
| 69584-361-95 | 69584036195 | 5000 TABLET in 1 BOTTLE (69584-361-95)Marketed from Sep 25, 2020 |
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 — 25 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Oxford Pharmaceuticals, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 087059
- Marketing start
- Listing expires
- Other FDA classes
- Increased Diuresis (Physiologic effect)Thiazides (Chemical structure)
- Identifiers
- Product ID 69584-361_a86b0c8b-1ae7-4bfc-a236-c3d7fdd8959cSPL ID a86b0c8b-1ae7-4bfc-a236-c3d7fdd8959cSPL set ID afbb9a0e-c22f-4133-8015-b4b2ab4d32e6RxCUI 197770, 310798UNII 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
N469584036110followed by a unit qualifier and the quantityPackage 69584-0361-10. 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 has also been found useful in edema due to various forms of renal dysfunction such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure. Hydrochlorothiazide is 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.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 087059
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 | Proficient Rx LP | 82804-972 |
| Hydrochlorothiazide | Hydrochlorothiazide 25 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-296 |
| Hydrochlorothiazide | Hydrochlorothiazide 25 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-088 |
| Hydrochlorothiazide | Hydrochlorothiazide 25 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-381 |
| Hydrochlorothiazide | Hydrochlorothiazide 25 mg/1 | TabletOral | A-S Medication Solutions | 50090-6157 |
| Hydrochlorothiazide | Hydrochlorothiazide 25 mg/1 | TabletOral | A-S Medication Solutions | 50090-6158 |
| Hydrochlorothiazide | Hydrochlorothiazide 25 mg/1 | TabletOral | A-S Medication Solutions | 50090-6160 |
| Hydrochlorothiazide | Hydrochlorothiazide 25 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4113 |