valsartan and hydrochlorothiazide 320 mg; 12.5 mg Tablet, Film Coated
by Zydus Lifesciences Limited · 10 BLISTER PACK in 1 CARTON (70771-1488-4) / 10 TABLET, FILM COATED in 1 BLISTER PACK
NDC 70771-1488-04
🏷️ FDA NDC (as labeled)
70771-1488-4
billing pads the package segment with a zero
This package
Contains10 tablet, film coated in 1 blister pack
Pack sizes3 compare ↓
Also priced by: Part D plans $0.3156/unit — full pricing hub ↓
Rx only
Generic
On market
Non-controlled
🗂️ Data synced Sep 10, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
🆔 Identity & classification
FDA NDC (as labeled)
70771-1488-4
Product NDC
70771-1488
11-digit billing NDC
70771148804
UNII
0J48LPH2TH, 80M03YXJ7I
UPC
0370771148905
Application #
ANDA203000
SPL Set ID
bd199010-1d85-4011-939c-4704ecfaba1f
Established class (EPC)
Thiazide Diuretic; Angiotensin 2 Receptor Blocker
Mechanism of action
Angiotensin 2 Receptor Antagonists
Physiologic effect
Increased Diuresis
Chemical class
Thiazides
DEA schedule
Non-controlled
Marketing category
ANDA
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2020-02-12
Route
ORAL
Dosage form
TABLET, FILM COATED
Substance
VALSARTAN; HYDROCHLOROTHIAZIDE
Why two NDCs?
The FDA registers this code as 70771-1488-4 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 70771-1488-04. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.
🏷️ RxNorm drug class
This medicine belongs to the Thiazide Diuretic class.
Pharmacologic class
Thiazide Diuretic
Drug family (ATC)
Renin-inhibitors, Thiazides, plain
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.
🏭 Manufacturer & labeler
LabelerZydus Lifesciences Limited
Application holderZYDUS LIFESCIENCES LTD
FDA applicationANDA203000 (ANDA)
Labeler code70771
First marketedFeb 2020
Product typeHuman Prescription Drug
Portfolio717 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.
🩺 Clinical
📖 What it is MedlinePlus · NLM
Hydrochlorothiazide is used alone or in combination with other medications to treat high blood pressure. Hydrochlorothiazide is used to treat edema (fluid retention; excess fluid held in body tissues) caused by various medical problems, including heart, kidney, and liver disease and to treat edema caused by using certain medications including estrogen and corticosteroids. Hydrochlorothiazide is in a class of medications called diuretics ('water pills'). It works by causing the kidneys to get rid of unneeded water and salt from the body into the urine. High blood pressure is a common condition...
Read the full MedlinePlus article ↗📗 Our plain-language guide HelloPharmacist
- This tablet combines two different blood pressure-lowering medicines in one pill: valsartan, which relaxes your blood vessels, and hydrochlorothiazide, a water pill that helps your...
- What exactly is this medication and why did my doctor prescribe it?
- You can take it either way — with or without food. The hydrochlorothiazide part isn't affected by food at all. Food does reduce how much valsartan your body absorbs, but since you...
- Does it matter if I take it with food or on an empty stomach?
Patient education
Supplement & herbal interactions
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.
💬 Questions about valsartan and hydrochlorothiazide?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
Color
Pink / Brown
ShapeOval
Imprint283
Size21 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.
🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
-
UNII L11K75P92J
A mineral salt made from calcium and phosphate. It acts as a filler and binder in tablets to add bulk and help hold the medicine together in solid form.
-
UNII OP1R32D61U
Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
-
UNII 2S7830E561
Crospovidone is a synthetic polymer derived from povidone. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the active ingredient can be absorbed.
-
UNII 1K09F3G675
Ferric oxide red is an inorganic iron compound used as a colorant in medicines. It gives tablets, capsules, or other dosage forms a red or reddish tint for identification and appearance.
-
UNII EX438O2MRT
Ferric oxide yellow is a naturally occurring iron compound used as a colorant in medications. It gives tablets, capsules, and other forms a yellow or golden hue for identification and appearance.
-
UNII 3NXW29V3WO
Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
-
UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
-
UNII 4R4HFI6D95
Polyethylene glycol 4000 is a synthetic polymer derived from petroleum. It serves as a binder, filler, and lubricant in solid dosage forms, and helps control how quickly the medicine dissolves.
-
UNII ETJ7Z6XBU4
Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
-
UNII 7SEV7J4R1U
A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
-
UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
11 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed —
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.
💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · Q2 2026 | $0.3156 | $31.56 / 100 tablets |
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Valsartan and Hydrochlorothiazide 320 mg/1; 12.5 mg 00378-6324-77 | Mylan | 90 tablets | $0.191 | AB | Availability likely | — |
| Valsartan and Hydrochlorothiazide 320 mg/1; 12.5 mg 33342-0077-10 | Macleods | 90 tablets | $0.191 | AB | Availability likely | — |
| Valsartan and Hydrochlorothiazide 320 mg/1; 12.5 mg 65862-0550-05 | Aurobindo | 500 tablets | $0.191 | — | Availability likely | — |
| Diovan HCT 320 mg/1; 12.5 mg 00078-0471-34 | Novartis | 90 tablets | — | AB | FDA listed | — |
| Valsartan and Hydrochlorothiazide 320 mg/1; 12.5 mg 42291-0968-90 | AvKARE | 90 tablets | — | AB | FDA listed | — |
| Valsartan And Hydrochlorothiazide 320 mg/1; 12.5 mg 43547-0314-03 | Solco | 30 tablets | — | AB | FDA listed | — |
| Valsartan and Hydrochlorothiazide 320 mg/1; 12.5 mg 46708-0456-10 | Alembic | 100 tablets | — | AB | FDA listed | — |
| Valsartan and Hydrochlorothiazide 320 mg/1; 12.5 mg 50090-5570-00 | A-S | 90 tablets | — | AB | FDA listed | — |
| Valsartan And Hydrochlorothiazide 320 mg/1; 12.5 mg 50090-7442-00 | A-S | 90 tablets | — | AB | FDA listed | — |
| Valsartan and Hydrochlorothiazide 320 mg/1; 12.5 mg 53746-0848-90 | Amneal | 90 tablets | — | AB | FDA listed | — |
| Valsartan and Hydrochlorothiazide 320 mg/1; 12.5 mg 62332-0082-10 | Alembic | 100 tablets | — | AB | FDA listed | — |
| Valsartan and Hydrochlorothiazide 320 mg/1; 12.5 mg 63187-0427-30 | Proficient | 30 tablets | — | AB | FDA listed | — |
| Valsartan and Hydrochlorothiazide 320 mg/1; 12.5 mg 63629-7282-01 | Bryant | 30 tablets | — | AB | FDA listed | — |
| Valsartan and Hydrochlorothiazide 320 mg/1; 12.5 mg 65162-0848-03 | Amneal | 30 tablets | — | AB | FDA listed | — |
| valsartan and hydrochlorothiazide 320 mg/1; 12.5 mgthis 70771-1488-04 | Zydus | 10 tablets | — | — | FDA listed | — |
| Valsartan and Hydrochlorothiazide 320 mg/1; 12.5 mg 71205-0042-30 | Proficient | 30 tablets | — | AB | FDA listed | — |
| Valsartan And Hydrochlorothiazide 320 mg/1; 12.5 mg 71335-3070-01 | Bryant | 30 tablets | — | AB | FDA listed | — |
| Valsartan And Hydrochlorothiazide 320 mg/1; 12.5 mg 50228-0150-05 | ScieGen | 500 tablets | — | AB | FDA listed | — |
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.
⏳ Availability & generic status
🏛️
2020
On the market since
Feb 2020
📍
2026
Currently FDA-listed
6 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.
🔬 Reported adverse events (FAERS)
Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Valsartan and Hydrochlorothiazide — the ingredient across all brands.
Top reported reactions
Age at onset
Reporter sex
Male · 36%
Female · 64%
Unknown · 0%
Serious outcomes
Reports over time (by year) — tap or hover for the count & year
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 70771-1488-00 | 1000 TABLET, FILM COATED in 1 BOTTLE (70771-1488-0) | 2020-02-12 | Active |
| 70771-1488-04 You're viewing this | 10 BLISTER PACK in 1 CARTON (70771-1488-4) / 10 TABLET, FILM COATED in 1 BLISTER PACK | 2020-02-12 | Active |
| 70771-1488-09 | 90 TABLET, FILM COATED in 1 BOTTLE (70771-1488-9) | 2020-02-12 | Active |
Pack size FAQ
What quantity is in NDC 70771-1488-04?
NDC 70771-1488-04 is listed by the FDA — 10 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack.
What NDC number is used to bill for this package of valsartan and hydrochlorothiazide 320 mg; 12.5 mg Tablet, Film Coated?
Bill NDC 70771-1488-04 — the 11-digit billing format is 70771148804. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.
🧭 About this NDC listing & data coverage
Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope. |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.
Questions about this listing
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 70771-1488-4, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 70771-1488-04, written without dashes as 70771148804. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 70771-1488-04, the first segment (70771) is the labeler code FDA assigned to Zydus Lifesciences Limited; the middle segment (1488) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (04) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Zydus Lifesciences Limited. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 90 tablets (70771-1488-09), 1000 tablets (70771-1488-00). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Zydus Lifesciences Limited is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
📄 Full prescribing information FDA SPL
The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
📄 FDA label ▾
No readable label sections were found for this product.
No label section mentions that — try another word, or open the full label on DailyMed below.
Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA.
Prefer the government’s original formatting? View this label on DailyMed ↗
For educational and professional reference only — not medical advice. Pricing reflects published
NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.