Prescription drug · NDA AUTHORIZED GENERIC
Hydrochlorothiazide NDC 63187-548
Hydrochlorothiazide 12.5 mg/1 · Capsule, Gelatin coated · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63187-548-07 | 63187054807 | 7 CAPSULE, GELATIN COATED in 1 BOTTLE (63187-548-07)Marketed from May 1, 2017 | |
| 63187-548-30 | 63187054830 | 30 CAPSULE, GELATIN COATED in 1 BOTTLE (63187-548-30)Marketed from May 1, 2017 | |
| 63187-548-60 | 63187054860 | 60 CAPSULE, GELATIN COATED in 1 BOTTLE (63187-548-60)Marketed from May 1, 2017 | |
| 63187-548-90 | 63187054890 | 90 CAPSULE, GELATIN COATED in 1 BOTTLE (63187-548-90)Marketed from May 1, 2017 |
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, Gelatin coated
- Route
- Oral
- Labeler
- Proficient Rx LP
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 020504
- Marketing start
- Listing expires
- Other FDA classes
- Increased Diuresis (Physiologic effect)Thiazides (Chemical structure)
- Identifiers
- Product ID 63187-548_75e914c5-6085-4f47-808b-f708657aa375SPL ID 75e914c5-6085-4f47-808b-f708657aa375SPL set ID c1052d38-fd75-40c2-a685-0e889009be0bRxCUI 199903UNII 0J48LPH2THUPC 0363187548902
- 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
N463187054807followed by a unit qualifier and the quantityPackage 63187-0548-07. 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 is 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 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 developed toxemia. Edema durin…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 020504
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 | Capsule, Gelatin coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 67544-739 |
| Hydrochlorothiazide | Hydrochlorothiazide 12.5 mg/1 | Capsule, Gelatin coatedOral | Actavis Pharma, Inc. | 0591-0347 |
| Hydrochlorothiazide | Hydrochlorothiazide 12.5 mg/1 | Capsule, Gelatin coatedOral | QPharma, Inc. | 42708-027 |