Prescription drug · ANDA
Hydrochlorothiazide NDC 16729-184
Hydrochlorothiazide 50 mg/1 · Tablet · Oral · Accord Healthcare Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 16729-184-01 | 16729018401 | 100 TABLET in 1 BOTTLE (16729-184-01)Marketed from Apr 26, 2013 | |
| 16729-184-17 | 16729018417 | 1000 TABLET in 1 BOTTLE (16729-184-17)Marketed from Apr 10, 2013 |
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 — 50 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Accord Healthcare Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202556
- Marketing start
- Listing expires
- Other FDA classes
- Increased Diuresis (Physiologic effect)Thiazides (Chemical structure)
- Identifiers
- Product ID 16729-184_4e6be915-b8a1-bef8-e063-6394a90a324cSPL ID 4e6be915-b8a1-bef8-e063-6394a90a324cSPL set ID babb1b20-fe82-40ba-8e7a-0c56fe433b4aRxCUI 197770, 310798, 429503UNII 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
N416729018401followed by a unit qualifier and the quantityPackage 16729-0184-01. 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 are indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Hydrochlorothiazide tablets 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 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 and exposes…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 202556
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 | A-S Medication Solutions | 50090-5333 |
| Hydrochlorothiazide | Hydrochlorothiazide 50 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-506 |
| Hydrochlorothiazide | Hydrochlorothiazide 12.5 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-502 |
| Hydrochlorothiazide | Hydrochlorothiazide 25 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-515 |
| Hydrochlorothiazide | Hydrochlorothiazide 50 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 68071-3323 |
| Hydrochlorothiazide | Hydrochlorothiazide 50 mg/1 | TabletOral | Proficient Rx LP | 71205-090 |
| Hydrochlorothiazide | Hydrochlorothiazide 25 mg/1 | TabletOral | Proficient Rx LP | 63187-367 |
| Hydrochlorothiazide | Hydrochlorothiazide 12.5 mg/1 | TabletOral | A-S Medication Solutions | 50090-1088 |
| Hydrochlorothiazide | Hydrochlorothiazide 50 mg/1 | TabletOral | DIRECT RX | 72189-263 |
| Hydrochlorothiazide | Hydrochlorothiazide 50 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-2405 |
| Hydrochlorothiazide | Hydrochlorothiazide 25 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-2411 |
| Hydrochlorothiazide | Hydrochlorothiazide 50 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0145 |
| Hydrochlorothiazide | Hydrochlorothiazide 12.5 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-7782 |
| Hydrochlorothiazide | Hydrochlorothiazide 12.5 mg/1 | TabletOral | Proficient Rx LP | 63187-553 |
| Hydrochlorothiazide | Hydrochlorothiazide 12.5 mg/1 | TabletOral | Accord Healthcare Inc. | 16729-182 |
| Hydrochlorothiazide | Hydrochlorothiazide 25 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 66267-106 |
| Hydrochlorothiazide | Hydrochlorothiazide 25 mg/1 | TabletOral | Accord Healthcare Inc. | 16729-183 |
| Hydrochlorothiazide | Hydrochlorothiazide 50 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 43063-747 |
| Hydrochlorothiazide | Hydrochlorothiazide 25 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0269 |