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Doxycycline hyclate 100 mg Capsule, 500-count — NDC 70771-1359-05 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Doxycycline hyclate 100 mg Capsule, 500-count — NDC 70771-1359-5 (Billing 70771-1359-05)

by Zydus Lifesciences Limited · 500 CAPSULE in 1 BOTTLE

This is a package of 500 capsules of Doxycycline hyclate 100 mg Capsule from Zydus Lifesciences Limited, marketed since Sep 2018 and currently FDA-listed.

NDC 70771-1359-05
🏷️ FDA NDC (as labeled) 70771-1359-5 billing pads the package segment with a zero
This package
Contains500-count Pack sizes5 compare ↓
Also priced by: Part D plans $0.2471/unit — full pricing hub ↓
Product page 70771-1359-00 Also comes in: 50 capsules 70771-1359-7 100 capsules 70771-1359-1 100 capsules 70771-1359-4 1000 capsules 70771-1359-0
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 Doxycycline Hyclate (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 · Sep 29, 2025 — Failed dissolution specifications: Stability testing found that the lot did not meet dissolution specifications. (Acella Pharmaceuticals, LLC) · FDA recall D-0014-2026
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) 70771-1359-5
Product NDC 70771-1359
11-digit billing NDC 70771135905
RxCUI 1649405, 1649988
UNII 19XTS3T51U
Application # ANDA207774
SPL Set ID fc8213e3-e546-495f-ac2c-3856db79c6e1
Established class (EPC) Tetracycline-class Drug
Chemical class Tetracyclines
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2018-09-12
Route ORAL
Dosage form CAPSULE
Substance DOXYCYCLINE HYCLATE
TE code (Orange Book) AB · RLD · RS
Quick answers
  • RxCUI (RxNorm): 1649405
Why two NDCs? The FDA registers this code as 70771-1359-5 — 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 → 70771-1359-05. 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 Tetracycline-class Drug class.

Pharmacologic class Tetracycline-class Drug
Drug family (ATC) Antiinfectives and antiseptics for local oral treatment, Tetracyclines
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

📗 Our plain-language guide HelloPharmacist
  • It is an antibiotic for bacterial infections such as rickettsial infections, sexually transmitted infections, respiratory tract infections and eye infections. Some products are als...
  • Take it exactly as your prescriber and label say. Swallow capsules with a full glass of water and avoid taking them right before lying down. For one capsule product, take it at lea...
  • Diarrhea, nausea, vomiting, stomach upset and loss of appetite are the most common. You may also sunburn much more easily, so cover up and avoid tanning beds. Call me or your docto...
  • Call right away for severe or watery diarrhea, a blistering or peeling rash, headache with vision changes, trouble swallowing, or signs of an allergic reaction. Diarrhea can show u...
📖 Read our full Doxycycline guide →
7
Nutrient depletion considerations

Doxycycline Hyclate may be associated with lower levels of 7 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Doxycycline Hyclate 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 $0.2471 $123.55 / 500 capsules
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
70771-1359-00 70771-1359-0 Main listing 1000 CAPSULE in 1 BOTTLE 2018-09-12 — Active
70771-1359-01 70771-1359-1 100 CAPSULE in 1 BOTTLE 2018-09-12 — Active
70771-1359-04 70771-1359-4 10 BLISTER PACK in 1 CARTON / 10 CAPSULE in 1 BLISTER PACK 2018-09-12 — Active
70771-1359-05 You're viewing this 500 CAPSULE in 1 BOTTLE 2018-09-12 — Active
70771-1359-07 70771-1359-7 50 CAPSULE in 1 BOTTLE 2018-09-12 — Active

Pack size FAQ

What quantity is in this package?
This is a 500-count package — 500 capsule in 1 bottle.
How does this package differ from NDC 70771-1359-07?
Both are Doxycycline hyclate 100 mg Capsule — the drug itself is identical. This page's package is the 500-count one, while NDC 70771-1359-07 is the 50 capsules package.
What NDC number is used to bill for this package of Doxycycline hyclate 100 mg Capsule?
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
Doxycycline Hyclate 100 mg 00143-9803-05 Hikma 500 capsules $0.105 AB Availability likely —
Doxycycline Hyclate 100 mg 00904-0428-04 Major 30 capsules $0.105 AB Availability likely —
doxycycline 100 mg 27808-0233-01 Cranbury 50 capsules $0.105 AB Availability likely —
Doxycycline Hyclate 100 mg 50268-0278-15 AvPAK 50 capsules $0.105 AB Availability likely —
Doxycycline Hyclate 100 mg 53489-0119-02 Sun 50 capsules $0.105 AB Availability likely —
Doxycycline Hyclate 100 mg 60687-0513-65 American 50 capsules $0.105 AB Availability likely —
doxycycline hyclate 100 mg 62332-0363-50 Alembic 50 capsules $0.105 AB Availability likely —
Doxycycline Hyclate 100 mg 69238-1100-02 Amneal 50 capsules $0.105 AB Availability likely —
Doxycycline Hyclate 100 mg 27241-0141-08 Ajanta 500 capsules — — FDA listed —
Doxycycline Hyclate 100 mg 33342-0386-08 Macleods 50 capsules — AB FDA listed —
Doxycycline Hyclate 100 mg 43063-0988-20 PD-Rx 20 capsules — AB FDA listed —
Doxycycline Hyclate 100 mg 43063-0999-06 PD-Rx 6 capsules — AB FDA listed —
doxycycline hyclate 100 mg 46708-0363-50 Alembic 50 capsules — AB FDA listed —
Doxycycline Hyclate 100 mg 49999-0126-30 Quality 30 capsules — AB FDA listed —
doxycycline hyclate 100 mg 50090-5560-01 A-S 20 capsules — AB FDA listed —
doxycycline hyclate 100 mg 50090-5588-00 A-S 20 capsules — AB FDA listed —
doxycycline 100 mg 50090-7410-01 A-S 14 capsules — AB FDA listed —
doxycycline 100 mg 50090-7411-01 A-S 20 capsules — AB FDA listed —
Doxycycline Hyclate 100 mg 51655-0478-20 Northwind 20 capsules — AB FDA listed —
Doxycycline Hyclate 100 mg 60219-1100-01 Amneal 100 capsules — AB FDA listed —
doxycycline 100 mg 60760-0721-20 ST. 20 capsules — AB Discontinued —
Doxycycline Hyclate 100 mg 61919-0082-20 DIRECT 20 capsules — AB FDA listed —
doxycycline hyclate 100 mg 62135-0985-01 Chartwell 100 capsules — AB FDA listed —
Doxycycline Hyclate 100 mg 67046-0135-03 Coupler 30 capsules — AB FDA listed —
doxycycline 100 mg 68071-2761-02 NuCare 2 capsules — AB Discontinued —
Doxycycline Hyclate 100 mg 68071-4883-04 NuCare 4 capsules — AB FDA listed —
Doxycycline Hyclate 100 mg 68071-4950-02 NuCare 20 capsules — AB FDA listed —
Doxycycline Hyclate 100 mg 68071-5232-04 NuCare 4 capsules — AB FDA listed —
Doxycycline Hyclate 100 mg 68071-5259-02 NuCare 20 capsules — AB FDA listed —
doxycycline 100 mg 68788-8588-01 Preferred 14 capsules — AB FDA listed —
doxycycline hyclate 100 mg 68999-0985-05 Chartwell 500 capsules — AB FDA listed —
Doxycycline Hyclate 100 mg 69434-0017-03 Zhejiang 500 capsules — — FDA listed —
Doxycycline Hyclate 100 mg 70518-1248-00 REMEDYREPACK 14 capsules — AB FDA listed —
Doxycyclate Hyclate 100 mg 70518-1627-00 REMEDYREPACK 30 capsules — AB FDA listed —
doxycycline 100 mg 70518-3488-00 REMEDYREPACK 20 capsules — AB FDA listed —
Doxycycline hyclate 100 mg 70518-4150-00 REMEDYREPACK 14 capsules — AB FDA listed —
doxycycline 100 mg 70518-4655-00 REMEDYREPACK 10 capsules — AB FDA listed —
Doxycycline Hyclate 100 mg 70518-4658-00 REMEDYREPACK 6 capsules — AB FDA listed —
Doxycycline hyclate 100 mgthis 70771-1359-05 Zydus 500 capsules — AB FDA listed —
Doxycycline Hyclate 100 mg 71205-0385-14 Proficient 14 capsules — AB FDA listed —
doxycycline hyclate 100 mg 71205-0518-02 Proficient 2 capsules — AB FDA listed —
Doxycycline Hyclate 100 mg 71335-0861-00 Bryant 6 capsules — AB FDA listed —
Doxycycline Hyclate 100 mg 71335-1464-00 Bryant 6 capsules — AB FDA listed —
doxycycline hyclate 100 mg 71335-1549-00 Bryant 6 capsules — AB FDA listed —
Doxycycline hyclate 100 mg 71335-2086-00 Bryant 6 capsules — AB FDA listed —
doxycycline 100 mg 71335-2100-00 Bryant 6 capsules — AB FDA listed —
Doxycycline 100 mg 72189-0006-20 Direct_Rx 20 capsules — AB FDA listed —
Doxycycline Hyclate 100 mg 72189-0559-20 Diirect_rx 20 capsules — AB FDA listed —
Doxycycline hyclate 100 mg 72578-0055-01 Viona 100 capsules — AB FDA listed —
Doxycycline Hyclate 100 mg 72789-0277-20 PD-Rx 20 capsules — AB FDA listed —
Doxycycline Hyclate 100 mg 72789-0298-20 PD-Rx 20 capsules — AB FDA listed —
Doxycycline Hyclate 100 mg 72789-0369-02 PD-Rx 2 capsules — AB FDA listed —
Doxycycline Hyclate 100 mg 76420-0044-10 Asclemed 10 capsules — AB FDA listed —
doxycycline 100 mg 76420-0562-10 Asclemed 10 capsules — AB FDA listed —
Doxycycline hyclate 100 mg 76420-0813-00 Asclemed 1000 capsules — AB FDA listed —
Doxycycline Hyclate 100 mg 80425-0114-02 Advanced 30 capsules — AB FDA listed —
Doxycycline Hyclate 100 mg 80425-0211-01 Advanced 20 capsules — AB FDA listed —
Doxycycline Hyclate 100 mg 80425-0280-01 Advanced 10 capsules — AB FDA listed —
doxycycline 100 mg 82804-0046-06 Proficient 6 capsules — AB FDA listed —
Doxycycline hyclate 100 mg 82804-0179-14 Proficient 14 capsules — AB FDA listed —
Doxycycline 100 mg 83112-0233-28 Health 28 capsules — AB FDA listed —
Doxycycline Hyclate 100 mg 83112-0985-05 Health 1 capsule — AB FDA listed —
Doxycycline hyclate 100 mg 85766-0033-00 Sportpharm 1000 capsules — AB FDA listed —
doxycycline hyclate 100 mg 85766-0052-01 Sportpharm 100 capsules — AB FDA listed —
Doxycycline Hyclate 100 mg 87441-0029-01 Unit 30 capsules — AB FDA listed —
doxycycline hyclate 100 mg 85534-0048-00 HAWAII 10 capsules — 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

🏛️
2018
On the market since
Sep 2018
📍
2026
Currently FDA-listed
8 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 Blue / White
ShapeCapsule
ImprintCHL;D76
Size2 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 3K9958V90M
    A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
  • UNII 5138Q19F1X
    Ammonia is a colorless gas made from nitrogen and hydrogen. It's used in medicines as a pH buffer to maintain the correct acidity level and help keep the product stable.
  • UNII 3SY5LH9PMK
    Anhydrous lactose is a milk sugar with no water content. It acts as a filler and binder in tablets and capsules, adding bulk and helping ingredients stick together.
  • UNII 8PJ61P6TS3
    Butyl alcohol is a clear liquid organic solvent derived from petroleum or natural sources. In medicines, it helps dissolve active ingredients and serves as a solvent in liquid formulations and some topical products.
  • 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 M28OL1HH48
    Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
  • UNII 767IP0Y5NH
    A synthetic red colorant used to give medicines their color. It helps patients identify their medication and makes the product visually appealing.
  • UNII H3R47K3TBD
    FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
  • UNII XM0M87F357
    A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
  • UNII 2G86QN327L
    Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
  • UNII ND2M416302
    Isopropyl alcohol is a clear liquid solvent derived from petroleum. In medicines, it dissolves active ingredients and other components, helps the product flow smoothly, and aids in sterilization during manufacturing.
  • 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 WZH3C48M4T
    Potassium hydroxide is a strong alkaline chemical used in medicines to adjust and maintain the pH level of liquid formulations, helping keep the product stable and the active ingredients effective.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII 46N107B71O
    Shellac is a natural resin secreted by the lac beetle. It's used as a coating on tablets and capsules to control how quickly the medicine dissolves and to improve appearance and stability.
  • UNII 368GB5141J
    A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
  • 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.

17 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 LIFESCIENCES LTD
FDA applicationANDA207774 (ANDA)
Labeler code70771
First marketedSep 2018
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.

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
📄 FDA label 9 words ▾

No readable label sections were found for this product.

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

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Doxycycline Hyclate — the program that covers self-administered drugs. 29 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Doxycycline Hyclate. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$19.44M
Claims incl. refills
1.9M
Beneficiaries
1.6M
Spend / beneficiary
$12.09
Spend / claim
$10.40
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

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 4 other package presentations of this same product, including 50 capsules (70771-1359-07), 100 capsules (70771-1359-01), 100 capsules (70771-1359-04). 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.
← 70771-1358-00 · Zydus 70771-1361-00 · 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.