What is NDC 16571-828?

16571-828 is the product NDC for Captopril And Hydrochlorothiazide, Captopril 25 mg/1; Hydrochlorothiazide 25 mg/1 tablet, listed with the FDA by Rising Pharma Holdings, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

What is the active ingredient?

Captopril, Hydrochlorothiazide.

Rising Pharma Holdings, Inc., NDC labeler code 16571. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Captopril And Hydrochlorothiazide?

3 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Captopril And Hydrochlorothiazide NDC 16571-828

NDC codes

FDA NDC Directory

Product NDC (as listed)16571-828Labeler and product segments. Claims need a package NDC.

Product NDC at billing width16571-0828Add 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	Copy
16571-828-09	1657108280916571082809	90 TABLET in 1 BOTTLE (16571-828-09)Marketed from Feb 14, 2023

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): Captopril And Hydrochlorothiazide
Generic name (nonproprietary): captopril and hydrochlorothiazide
Active ingredients: Captopril — 25 mg/1Hydrochlorothiazide — 25 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Rising Pharma Holdings, Inc.NDC labeler code 16571
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 074896
Marketing start: Feb 14, 2023
Listing expires: Dec 31, 2027
Other FDA classes: Angiotensin-converting Enzyme Inhibitors (Mechanism)Increased Diuresis (Physiologic effect)Thiazides (Chemical structure)
Identifiers: Product ID 16571-828_0ea90fd4-0da6-4ad2-ab83-6cfbe0ae515eSPL ID 0ea90fd4-0da6-4ad2-ab83-6cfbe0ae515eSPL set ID 0ea90fd4-0da6-4ad2-ab83-6cfbe0ae515eRxCUI 197436, 197437, 197438, 197439UNII 0J48LPH2TH, 9G64RSX1XD
Pharmacologic class: Angiotensin Converting Enzyme Inhibitor; 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

N416571082809 followed by a unit qualifier and the quantity

Package 16571-0828-09. 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 Feb 21, 2023. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS & USAGE Captopril and hydrochlorothiazide tablets are indicated for the treatment of hypertension. The blood pressure lowering effects of captopril and thiazides are approximately additive. This fixed combination drug may be used as initial therapy or substituted for previously titrated doses of the individual components. When captopril and hydrochlorothiazide are given together it may not be necessary to administer captopril in divided doses to attain blood pressure control at trough (before the next dose). Also, with such a combination, a daily dose of 15 mg of hydrochlorothiazide may be adequate. Treatment may, therefore, be initiated with captopril and hydrochlorothiazide tab…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 16571-828

What is NDC 16571-828?: 16571-828 is the product NDC for Captopril And Hydrochlorothiazide, Captopril 25 mg/1; Hydrochlorothiazide 25 mg/1 tablet, listed with the FDA by Rising Pharma Holdings, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Captopril And Hydrochlorothiazide.
What is the active ingredient?: Captopril, Hydrochlorothiazide.
Who is the labeler?: Rising Pharma Holdings, Inc., NDC labeler code 16571. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Captopril And Hydrochlorothiazide?: 3 other product NDCs are listed under this name. See all Captopril And Hydrochlorothiazide NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Captopril And Hydrochlorothiazide NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Captopril And Hydrochlorothiazide	Captopril 25 mg/1; Hydrochlorothiazide 15 mg/1	TabletOral	Rising Pharma Holdings, Inc.	16571-827	16571-0827-09
Captopril And Hydrochlorothiazide	Captopril 50 mg/1; Hydrochlorothiazide 15 mg/1	TabletOral	Rising Pharma Holdings, Inc.	16571-829	16571-0829-09
Captopril And Hydrochlorothiazide	Captopril 50 mg/1; Hydrochlorothiazide 25 mg/1	TabletOral	Rising Pharma Holdings, Inc.	16571-830	16571-0830-09

Other NDCs under ANDA 074896

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

FDA NDC Directory listings under ANDA 074896
Product	Strength	Form · route	Labeler	Product NDC
Captopril And Hydrochlorothiazide	Captopril 25 mg/1; Hydrochlorothiazide 15 mg/1	TabletOral	Rising Pharma Holdings, Inc.	16571-827
Captopril And Hydrochlorothiazide	Captopril 50 mg/1; Hydrochlorothiazide 15 mg/1	TabletOral	Rising Pharma Holdings, Inc.	16571-829
Captopril And Hydrochlorothiazide	Captopril 50 mg/1; Hydrochlorothiazide 25 mg/1	TabletOral	Rising Pharma Holdings, Inc.	16571-830