budesonide 3 mg Capsule, Coated Pellets
by Zydus Lifesciences Limited · 10 BLISTER PACK in 1 CARTON (70771-1075-4) / 10 CAPSULE, COATED PELLETS in 1 BLISTER PACK
NDC 70771-1075-04
🏷️ FDA NDC (as labeled)
70771-1075-4
billing pads the package segment with a zero
This package
Contains10 capsule, coated pellets in 1 blister pack
Pack sizes6 compare ↓
Also priced by: Part D plans $1.00/unit — full pricing hub ↓
Also comes in:
30 capsules 70771-1075-03
90 capsules 70771-1075-09
100 capsules 70771-1075-01
500 capsules 70771-1075-05
1000 capsules 70771-1075-00
Rx only
Generic
On market
Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
⚠️
Other active recalls for Budesonide (different manufacturers) — 3 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · May 29, 2026 — Presence of Foreign Substance:This recall has been initiated in response to a product quality complaint reported for black/brown specs and particles within the ampoule solution (SUN PHARMACEUTICAL INDUSTRIES INC) · FDA recall D-0607-2026
Class II · Jun 30, 2025 — Lack of Assurance of Sterility: A market complaint was received for leakage and empty ampoule. (Cipla USA, Inc.) · FDA recall D-0541-2025
Class II · Jan 8, 2024 — Failed Dissolution Specifications (Teva Pharmaceuticals USA, Inc) · FDA recall D-0275-2024
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗
🆔 Identity & classification
FDA NDC (as labeled)
70771-1075-4
Product NDC
70771-1075
11-digit billing NDC
70771107504
RxCUI
1244214
UNII
Q3OKS62Q6X
UPC
0368382720016
Application #
ANDA206134
SPL Set ID
d645a346-c99b-4de7-9bca-69e73266d6b4
Established class (EPC)
Corticosteroid
Mechanism of action
Corticosteroid Hormone Receptor Agonists
DEA schedule
Non-controlled
Marketing category
ANDA
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2017-06-08
Route
ORAL
Dosage form
CAPSULE, COATED PELLETS
Substance
BUDESONIDE
TE code (Orange Book)
AB · RLD · RS
Why two NDCs?
The FDA registers this code as 70771-1075-4 — 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 → 70771-1075-04. 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 Corticosteroid class.
Pharmacologic class
Corticosteroid
Drug family (ATC)
Corticosteroids acting locally, Corticosteroids, potent (group III), Corticosteroids
How it works
Corticosteroid Hormone Receptor Agonists
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 PHARMACEUTICALS USA INC
FDA applicationANDA206134 (ANDA)
Labeler code70771
First marketedJun 2017
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
Budesonide (Entocort EC) is used to treat Crohn's disease (a condition in which the body attacks the lining of the digestive tract, causing pain, diarrhea, weight loss, and fever) in adults and children 8 years of age and older. Budesonide (Tarpeyo) is used to decrease protein in the urine in patients with primary immunoglobulin A nephropathy (kidney disease that occurs in some people when too much immunoglobin A builds up in the kidney, causing inflammation). Budesonide (Uceris) is used to treat ulcerative colitis (a condition which causes swelling and sores in the lining of the colon [large...
Read the full MedlinePlus article ↗📗 Our plain-language guide HelloPharmacist
- No — and this is really important to understand. Budesonide inhalation suspension is a daily controller medication, not a rescue treatment. It works by slowly calming inflammation...
- My child has asthma. Can I use this nebulizer treatment when they're having an attack?
- You may start to notice some improvement in your child's asthma symptoms within 2 to 8 days of starting treatment. But full benefit — where the airways are as calm and well-control...
- Yes, please do — it makes a real difference. Inhaled steroids like budesonide can leave a small amount of residue in the mouth and throat, which can lead to a yeast infection calle...
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Budesonide — tap one for details:
8
Nutrient depletion considerations
Budesonide may be associated with lower levels of 8 nutrients — worth a chat with your pharmacist, not a cause for alarm.
ZINC
Insignificant Depletion
CALCIUM
Moderate Depletion
CHROMIUM
Moderate Depletion
MAGNESIUM
Moderate Depletion
POTASSIUM
Moderate Depletion
+3 more
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.
💬 Questions about budesonide?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
Color
Orange / White
ShapeCapsule
Imprint720
Size19 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 0ZBX0N59RZ
A plasticizer derived from citric acid that is added to tablet coatings and film formulations. It increases flexibility and durability of the coating layer, helping the tablet withstand handling and moisture without cracking.
-
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 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 92RU3N3Y1O
Dimethicone is a silicone-based oil that acts as an anti-foaming agent and lubricant in medicines. It reduces gas bubbles in liquid formulations and helps coat and protect the stomach lining when ingested.
-
UNII 7Z8S9VYZ4B
Ethylcellulose is a plant-derived thickener and film-former made by chemically modifying cellulose. It's used as a binder to hold tablet ingredients together, a coating to control how quickly medicine is released, or a thickener in liquid formulations.
-
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 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 NX76LV5T8J
A synthetic plastic polymer made from methacrylic acid and ethyl acrylate. It's used as a coating or binder to control how and where the medicine dissolves in your digestive system.
-
UNII 6OZP39ZG8H
Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
-
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 C151H8M554
A natural sugar derived from sugar cane or sugar beets. It's used as a sweetener, filler, and binder to improve taste, add bulk, and help hold tablet or capsule ingredients together.
-
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.
-
UNII 8Z96QXD6UM
Triethyl citrate is a clear liquid derived from citric acid. It acts as a plasticizer and solvent in tablet coatings and film formulations, helping the coating remain flexible and adhere properly to the medicine.
-
UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
22 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 | $1.00 | $100.21 / 100 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.
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| budesonide 3 mg 00574-9855-10 | Padagis | 100 capsules | $0.499 | AB | Availability likely | — |
| budesonide 3 mg 00904-7313-10 | Major | 1 capsule | $0.499 | AB | Availability likely | — |
| budesonide 3 mg 16714-0829-01 | Northstar | 100 capsules | $0.499 | AB | Availability likely | — |
| Budesonide 3 mg 53746-0778-10 | Amneal | 100 capsules | $0.499 | AB | Availability likely | — |
| Budesonide 3 mg 60687-0596-32 | American | 1 capsule | $0.499 | AB | Availability likely | — |
| Budesonide 3 mg 65162-0778-10 | Amneal | 100 capsules | $0.499 | AB | Availability likely | — |
| budesonide 3 mg 68382-0720-01 | Zydus | 100 capsules | $0.499 | AB | Availability likely | — |
| budesonide 3 mg 51407-0591-01 | Golden | 100 capsules | — | AB | FDA listed | — |
| Budesonide 3 mg 63629-8294-01 | Bryant | 30 capsules | — | AB | FDA listed | — |
| budesonide 3 mg 70518-4613-00 | REMEDYREPACK | 1 capsule | — | AB | FDA listed | — |
| budesonide 3 mgthis 70771-1075-04 | Zydus | 10 capsules | — | AB | FDA listed | — |
| budesonide 3 mg 72162-2473-01 | Bryant | 100 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
🏛️
2017
On the market since
Jun 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.
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
Medicare Part D (outpatient prescription) spending for Budesonide — the program that covers self-administered drugs. 12 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 Budesonide. 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
$10.81M
Claims incl. refills
53.9K
Beneficiaries
24.2K
Spend / beneficiary
$447.22
Spend / claim
$200.39
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.
🔬 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 Budesonide — the ingredient across all brands.
Top reported reactions
Age at onset
Reporter sex
Male · 38%
Female · 62%
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 |
|---|---|---|---|
| 70771-1075-00 | 1000 CAPSULE, COATED PELLETS in 1 BOTTLE (70771-1075-0) | 2017-06-08 | Active |
| 70771-1075-01 | 100 CAPSULE, COATED PELLETS in 1 BOTTLE (70771-1075-1) | 2017-06-08 | Active |
| 70771-1075-03 | 30 CAPSULE, COATED PELLETS in 1 BOTTLE (70771-1075-3) | 2017-06-08 | Active |
| 70771-1075-04 You're viewing this | 10 BLISTER PACK in 1 CARTON (70771-1075-4) / 10 CAPSULE, COATED PELLETS in 1 BLISTER PACK | 2017-06-08 | Active |
| 70771-1075-05 | 500 CAPSULE, COATED PELLETS in 1 BOTTLE (70771-1075-5) | 2017-06-08 | Active |
| 70771-1075-09 | 90 CAPSULE, COATED PELLETS in 1 BOTTLE (70771-1075-9) | 2017-06-08 | Active |
Pack size FAQ
What quantity is in NDC 70771-1075-04?
NDC 70771-1075-04 is listed by the FDA — 10 blister pack in 1 carton / 10 capsule, coated pellets in 1 blister pack.
What NDC number is used to bill for this package of budesonide 3 mg Capsule, Coated Pellets?
Bill NDC 70771-1075-04 — the 11-digit billing format is 70771107504. 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 | ✓ 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 FDA registers it as 70771-1075-4, 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: 70771-1075-04, written without dashes as 70771107504. 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 70771-1075-04, the first segment (70771) is the labeler code FDA assigned to Zydus Lifesciences Limited; the middle segment (1075) 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 5 other package presentations of this same product, including 30 capsules (70771-1075-03), 90 capsules (70771-1075-09), 100 capsules (70771-1075-01). 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.