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Labetalol Hydrochloride 100 mg Tablet, Film Coated, 100-count — NDC 70771-1163-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Labetalol Hydrochloride 100 mg Tablet, Film Coated, 100-count — NDC 70771-1163-1 (Billing 70771-1163-01)

by Zydus Lifesciences Limited · 100 TABLET, FILM COATED in 1 BOTTLE

This is a package of 100 tablets of Labetalol Hydrochloride 100 mg Tablet, Film Coated from Zydus Lifesciences Limited, marketed since Dec 2017 and currently FDA-listed. It is the main listing for this product, which comes in 4 package sizes.

NDC 70771-1163-01
🏷️ FDA NDC (as labeled) 70771-1163-1 billing pads the package segment with a zero
This package
Contains100-count Pack sizes4 compare ↓
Also priced by: Part D plans $0.1818/unit — full pricing hub ↓
Main listing for product 70771-1163 · Also comes in: 30 tablets 70771-1163-3 90 tablets 70771-1163-9 500 tablets 70771-1163-5
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️
Other active recalls for Labetalol Hydrochloride (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · May 20, 2024 — Lack of Assurance of Sterility-The potential for incomplete crimp seals. (Pfizer Inc.) · FDA recall D-0565-2024
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 70771-1163-1
Product NDC 70771-1163
11-digit billing NDC 70771116301
RxCUI 896758, 896762, 896766
UNII 1GEV3BAW9J
Application # ANDA207743
SPL Set ID a3c0cc1e-1c01-4009-afdc-d35a66546aec
Established class (EPC) beta-Adrenergic Blocker
Mechanism of action Adrenergic beta-Antagonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2017-12-05
Route ORAL
Dosage form TABLET, FILM COATED
Substance LABETALOL HYDROCHLORIDE
TE code (Orange Book) AB · RLD · RS
Quick answers
  • RxCUI (RxNorm): 896758
Why two NDCs? The FDA registers this code as 70771-1163-1 — 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 → 70771-1163-01. 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 beta-Adrenergic Blocker class.

Pharmacologic class beta-Adrenergic Blocker
Drug family (ATC) Alpha and beta blocking agents
How it works Adrenergic beta-Antagonists
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.

Clinical

📖 What it is MedlinePlus · NLM

Labetalol is used to treat high blood pressure. Labetalol is in a class of medications called beta blockers. It works by relaxing blood vessels and slowing heart rate to improve blood flow and decrease blood pressure.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Labetalol lowers blood pressure. The tablets are used for high blood pressure, and the IV form is used in the hospital for severe high blood pressure. Keeping blood pressure down r...
  • Take them by mouth, usually twice a day, as your prescriber directs. Food increases how much of the drug your body absorbs, so try to be consistent about taking it with or without...
  • Dizziness, nausea, tiredness and headache are the most common, and they often fade early in treatment. Standing up slowly helps with lightheadedness. Call your doctor if you get it...
  • Please don't stop suddenly. Stopping a beta blocker abruptly can worsen chest pain and, in some cases, lead to a heart attack. If you need to stop, your prescriber will lower the d...
📖 Read our full Labetalol guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
1
Nutrient depletion considerations

Labetalol may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Labetalol nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
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.

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 systemPer eachPer 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 $0.1818 $18.18 / 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
70771-1163-01 You're viewing this Main listing 100 TABLET, FILM COATED in 1 BOTTLE 2017-12-05 — Active
70771-1163-03 70771-1163-3 30 TABLET, FILM COATED in 1 BOTTLE 2017-12-05 — Active
70771-1163-05 70771-1163-5 500 TABLET, FILM COATED in 1 BOTTLE 2017-12-05 — Active
70771-1163-09 70771-1163-9 90 TABLET, FILM COATED in 1 BOTTLE 2017-12-05 — Active

You're viewing one of 4 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This is a 100-count package — 100 tablet, film coated in 1 bottle.
How does this package differ from NDC 70771-1163-03?
Both are Labetalol Hydrochloride 100 mg Tablet, Film Coated — the drug itself is identical. This page's package is the 100-count one, while NDC 70771-1163-03 is the 30 tablets package.
What NDC number is used to bill for this package of Labetalol Hydrochloride 100 mg Tablet, Film Coated?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Labetalol Hydrochloride 100 mg 71247-0126-01 Innogenix, 100 tablets $0.083 AB FDA listed —
Labetalol hydrochloride 100 mg 00591-0605-01 Actavis 100 tablets $0.084 AB Discontinued —
Labetalol Hydrochloride 100 mg 00904-7451-61 Major 1 tablet $0.084 AB Availability likely —
Labetalol Hydrochloride 100 mg 23155-0723-01 Heritage 100 tablets $0.084 AB Availability likely —
Labetalol Hydrochloride 100 mg 29300-0252-01 Unichem 100 tablets $0.084 — Availability likely —
Labetalol Hydrochloride 100 mg 58657-0602-01 Method 100 tablets $0.084 AB Availability likely —
Labetalol Hydrochloride 100 mg 58657-0906-01 Method 1 tablet $0.084 AB Availability likely —
Labetalol Hydrochloride 100 mg 60687-0439-01 American 1 tablet $0.084 AB Availability likely —
Labetalol Hydrochloride 100 mg 62135-0791-60 Chartwell 60 tablets $0.084 AB Availability likely —
Labetalol Hydrochloride 100 mg 68001-0381-00 BluePoint 100 tablets $0.084 AB Availability likely —
Labetalol Hydrochloride 100 mg 68001-0700-00 BluePoint 100 tablets $0.084 AB Availability likely —
Labetalol Hydrochloride 100 mg 68382-0798-01 Zydus 100 tablets $0.084 AB Availability likely —
Labetalol Hydrochloride 100 mg 72603-0902-01 NorthStar 100 tablets $0.084 AB Availability likely —
Labetalol Hydrochloride 100 mg 72888-0120-01 Advagen 100 tablets $0.084 AB Availability likely —
Labetalol Hydrochloride 100 mg 00615-8512-39 NCS 30 tablets — AB FDA listed —
Labetalol Hydrochloride 100 mg 10135-0711-01 Marlex 100 tablets — AB FDA listed —
Labetalol Hydrochloride 100 mg 33342-0515-11 Macleods 100 tablets — AB FDA listed —
Labetalol Hydrochloride 100 mg 42806-0327-01 Epic 100 tablets — AB FDA listed —
Labetalol Hydrochloride 100 mg 50090-6741-00 A-S 60 tablets — AB FDA listed —
Labetalol Hydrochloride 100 mg 50090-7457-00 A-S 60 tablets — AB FDA listed —
Labetalol Hydrochloride 100 mg 50090-7458-00 A-S 90 tablets — AB FDA listed —
Labetalol Hydrochloride 100 mg 51407-0614-01 Golden 100 tablets — AB FDA listed —
Labetalol Hydrochloride 100 mg 51655-0322-25 Northwind 60 tablets — AB FDA listed —
Labetalol Hydrochloride 100 mg 55154-0181-00 Cardinal 1 tablet — AB FDA listed —
Labetalol Hydrochloride 100 mg 55154-8192-00 Cardinal 1 tablet — AB FDA listed —
Labetalol Hydrochloride 100 mg 60760-0784-90 St. 90 tablets — AB FDA listed —
Labetalol Hydrochloride 100 mg 60760-0991-90 St. 90 tablets — AB FDA listed —
Labetalol Hydrochloride 100 mg 63629-1161-01 Bryant 100 tablets — AB FDA listed —
Labetalol Hydrochloride 100 mg 63629-1162-01 Bryant 500 tablets — AB FDA listed —
Labetalol Hydrochloride 100 mg 67296-2156-01 Redpharm 15 tablets — AB FDA listed —
Labetalol Hydrochloride 100 mg 70377-0060-11 Biocon 30 tablets — AB FDA listed —
Labetalol Hydrochloride 100 mg 70518-3499-00 REMEDYREPACK 30 tablets — AB FDA listed —
Labetalol Hydrochloride 100 mg 70518-4201-00 REMEDYREPACK 180 tablets — AB FDA listed —
Labetalol Hydrochloride 100 mgthis 70771-1163-01 Zydus 100 tablets — AB FDA listed —
Labetalol hydrochloride 100 mg 71205-0095-30 Proficient 30 tablets — AB FDA listed —
Labetalol Hydrochloride 100 mg 71209-0083-03 Cadila 60 tablets — AB FDA listed —
Labetalol HCL 100 mg 71335-2145-01 Bryant 30 tablets — — Discontinued —
Labetalol Hydrochloride 100 mg 71335-2475-01 Bryant 30 tablets — AB FDA listed —
Labetalol Hydrochloride 100 mg 71335-3065-01 Bryant 30 tablets — AB FDA listed —
Labetalol Hydrochloride 100 mg 72162-1675-01 Bryant 100 tablets — AB FDA listed —
Labetalol Hydrochloride 100 mg 82804-0289-90 Proficient 90 tablets — AB FDA listed —
Labetalol Hydrochloride 100 mg 67046-1693-03 Coupler 30 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

🏛️
2017
On the market since
Dec 2017
📍
2026
Currently FDA-listed
9 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.

What it looks like

Color Yellow / White / Green
ShapeRound
Imprint800
Size11 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 LMI26O6933
    Alumina is a white powder form of aluminum oxide. It's used as a filler to add bulk to tablets and capsules, and sometimes as a thickening or anti-caking agent in powdered formulations.
  • UNII 35SW5USQ3G
    A synthetic yellow dye used to color medicines. It helps make tablets, capsules, and liquids visually distinct so patients can easily identify their medication.
  • 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 EWQ57Q8I5X
    Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
  • 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 3WJQ0SDW1A
    Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
  • UNII 5856J3G2A2
    A starch-based powder made from potatoes and processed with sodium. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the medicine can be absorbed.
  • UNII O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
  • 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.

12 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.

Manufacturer & labeler

LabelerZydus Lifesciences Limited
Application holderZYDUS PHARMACEUTICALS USA INC
FDA applicationANDA207743 (ANDA)
Labeler code70771
First marketedDec 2017
Product typeHuman Prescription Drug
Portfolio720 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.

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.
📄 Package Label / Principal Display Panel
📄 Package Label / Principal Display Panel 46 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70771-1163-3 Labetalol hydrochloride tablets, 100 mg Rx only 30 tablets NDC 70771-1164-3 Labetalol hydrochloride tablets, 200 mg Rx only 30 tablets NDC 70771-1165-3 Labetalol hydrochloride tablets, 300 mg Rx only 30 tablets Labetalol hydrochloride tablets Labetalol hydrochloride tablets Labetalol hydrochloride tablets

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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 ✓ Available
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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
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 3 other package presentations of this same product, including 30 tablets (70771-1163-03), 90 tablets (70771-1163-09), 500 tablets (70771-1163-05). 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.
← 70771-1162-01 · Zydus 70771-1164-01 · Zydus →
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.