Prescription drug · ANDA
Hydrochlorothiazide NDC 69315-155
Hydrochlorothiazide 12.5 mg/1 · Tablet · Oral · Leading Pharma, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69315-155-01 | 6931501550169315015501 | 100 TABLET in 1 BOTTLE, PLASTIC (69315-155-01)Marketed from Nov 1, 2019 | |
| 69315-155-10 | 6931501551069315015510 | 1000 TABLET in 1 BOTTLE, PLASTIC (69315-155-10)Marketed from Nov 1, 2019 |
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
- Tablet
- Route
- Oral
- Labeler
- Leading Pharma, LLCNDC labeler code 69315
- 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 69315-155_12cad736-bf18-4ad0-8118-efc502f33e87SPL ID 12cad736-bf18-4ad0-8118-efc502f33e87SPL set ID 8c868894-667e-4a51-906a-838d63e420baRxCUI 197770, 310798, 429503UNII 0J48LPH2THUPC 0369315131107, 0369315131503, 0369315130100, 0369315155103
- 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
N469315015501followed by a unit qualifier and the quantityPackage 69315-0155-01. 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 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.
About NDC 69315-155
- What is NDC 69315-155?
- 69315-155 is the product NDC for Hydrochlorothiazide, Hydrochlorothiazide 12.5 mg/1 tablet, listed with the FDA by Leading Pharma, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Hydrochlorothiazide.
- What is the active ingredient?
- Hydrochlorothiazide.
- Who is the labeler?
- Leading Pharma, LLC, NDC labeler code 69315. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Hydrochlorothiazide?
- 166 other product NDCs are listed under this name. See all Hydrochlorothiazide NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Hydrochlorothiazide products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Hydrochlorothiazide | Hydrochlorothiazide 50 mg/5mL | SolutionOral | Advagen Pharma Ltd | 72888-491 | 72888-0491-01 |
| Hydrochlorothiazide | Hydrochlorothiazide 12.5 mg/1 | TabletOral | Teva Pharmaceuticals, Inc. | 0480-3444 | 00480-3444-10 |
| hydrochlorothiazide | Hydrochlorothiazide 12.5 mg/1 | CapsuleOral | Preferred Pharmaceuticals Inc. | 68788-4192 | 68788-4192-0168788-4192-0368788-4192-06+2 more |
| Hydrochlorothiazide | Hydrochlorothiazide 12.5 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4736 | 70518-4736-00 |
| Hydrochlorothiazide | Hydrochlorothiazide 25 mg/1 | TabletOral | Unit Dose Solutions, Inc. | 87441-038 | 87441-0038-01 |
| Hydrochlorothiazide | Hydrochlorothiazide 12.5 mg/1 | TabletOral | Coupler LLC | 67046-1664 | 67046-1664-03 |
| Hydrochlorothiazide | Hydrochlorothiazide 25 mg/1 | TabletOral | American Health Packaging | 60687-894 | 60687-0894-01 |
| Hydrochlorothiazide | Hydrochlorothiazide 50 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4525 | 70518-4525-00 |
| Hydrochlorothiazide | Hydrochlorothiazide 12.5 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4466 | 70518-4466-0070518-4466-01 |
| Hydrochlorothiazide | Hydrochlorothiazide 25 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4359 | 70518-4359-0070518-4359-0170518-4359-02+2 more |
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 12.5 mg/1 | TabletOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8449 |
| Hydrochlorothiazide | Hydrochlorothiazide 50 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 43353-240 |
| Hydrochlorothiazide | Hydrochlorothiazide 12.5 mg/1 | TabletOral | A-S Medication Solutions | 50090-6372 |
| Hydrochlorothiazide | Hydrochlorothiazide 12.5 mg/1 | TabletOral | A-S Medication Solutions | 50090-7817 |
| Hydrochlorothiazide | Hydrochlorothiazide 12.5 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-330 |
| Hydrochlorothiazide | Hydrochlorothiazide 25 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-331 |
| Hydrochlorothiazide | Hydrochlorothiazide 50 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-332 |
| Hydrochlorothiazide | Hydrochlorothiazide 12.5 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-674 |
| 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 25 mg/1 | TabletOral | Proficient Rx LP | 63187-440 |
| Hydrochlorothiazide | Hydrochlorothiazide 50 mg/1 | TabletOral | Proficient Rx LP | 63187-441 |
| Hydrochlorothiazide | Hydrochlorothiazide 12.5 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-3608 |
| Hydrochlorothiazide | Hydrochlorothiazide 12.5 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-3652 |
| Hydrochlorothiazide | Hydrochlorothiazide 12.5 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8813 |
| Hydrochlorothiazide | Hydrochlorothiazide 50 mg/1 | TabletOral | Leading Pharma, LLC | 69315-130 |
| Hydrochlorothiazide | Hydrochlorothiazide 25 mg/1 | TabletOral | Leading Pharma, LLC | 69315-131 |
| Hydrochlorothiazide | Hydrochlorothiazide 12.5 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4466 |
| Hydrochlorothiazide | Hydrochlorothiazide 12.5 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-9647 |
| Hydrochlorothiazide | Hydrochlorothiazide 50 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-471 |
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