Hydrochlorothiazide NDC 43547-397

NDC codes

FDA NDC Directory

Product NDC (as listed)43547-397Labeler and product segments. Claims need a package NDC.

Product NDC at billing width43547-0397Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package
43547-397-01	43547039701	10 TABLET in 1 BOTTLE, PLASTIC (43547-397-01)Marketed from Mar 29, 2002
43547-397-03	43547039703	30 TABLET in 1 BOTTLE, PLASTIC (43547-397-03)Marketed from Mar 29, 2002
43547-397-05	43547039705	50 TABLET in 1 BOTTLE, PLASTIC (43547-397-05)Marketed from Mar 29, 2002
43547-397-10	43547039710	100 TABLET in 1 BOTTLE, PLASTIC (43547-397-10)Marketed from Mar 29, 2002
43547-397-11	43547039711	1000 TABLET in 1 BOTTLE, PLASTIC (43547-397-11)Marketed from Mar 29, 2002
43547-397-15	43547039715	5000 TABLET in 1 BOTTLE, PLASTIC (43547-397-15)Marketed from Mar 29, 2002
43547-397-50	43547039750	500 TABLET in 1 BOTTLE, PLASTIC (43547-397-50)Marketed from Mar 29, 2002

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: Solco Healthcare U.S., LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 040412
Marketing start: Mar 29, 2002
Listing expires: Dec 31, 2026
Other FDA classes: Increased Diuresis (Physiologic effect)Thiazides (Chemical structure)
Identifiers: Product ID 43547-397_d8ce29b2-7f3a-4944-bf9e-0fcebb25d3c4SPL ID d8ce29b2-7f3a-4944-bf9e-0fcebb25d3c4SPL set ID 60c97ab9-b25e-4ea5-a159-792292178c65RxCUI 197770, 310798UNII 0J48LPH2THUPC 0343547397036
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

N443547039701 followed by a unit qualifier and the quantity

Package 43547-0397-01. 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 May 20, 2020.

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 m…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 040412

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 040412
Product	Strength	Form · route	Labeler	Product NDC
Hydrochlorothiazide	Hydrochlorothiazide 50 mg/1	TabletOral	Bryant Ranch Prepack	71335-1451
Hydrochlorothiazide	Hydrochlorothiazide 50 mg/1	TabletOral	Bryant Ranch Prepack	72162-1357
Hydrochlorothiazide	Hydrochlorothiazide 25 mg/1	TabletOral	Bryant Ranch Prepack	71335-1481
Hydrochlorothiazide	Hydrochlorothiazide 50 mg/1	TabletOral	Bryant Ranch Prepack	63629-8992
Hydrochlorothiazide	Hydrochlorothiazide 25 mg/1	TabletOral	American Health Packaging	60687-593
Hydrochlorothiazide	Hydrochlorothiazide 50 mg/1	TabletOral	Bryant Ranch Prepack	63629-1220
Hydrochlorothiazide	Hydrochlorothiazide 25 mg/1	TabletOral	Bryant Ranch Prepack	63629-1218
Hydrochlorothiazide	Hydrochlorothiazide 50 mg/1	TabletOral	Solco Healthcare U.S., LLC	43547-398