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docusate sodium 100 mg Capsule, 15,000-count — NDC 11523-8258-1 (Billing 11523-8258-01)

by Bayer HealthCare LLC. · 15000 CAPSULE in 1 BAG

This is a package of 15,000 capsules of docusate sodium 100 mg Capsule from Bayer HealthCare LLC., marketed since Dec 2025 and currently FDA-listed. It is this product's only package size.

NDC 11523-8258-01
🏷️ FDA NDC (as labeled) 11523-8258-1 billing pads the package segment with a zero
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

NDC database record

One package, one record: these facts belong to NDC 11523-8258-1 alone.

Record
FDA NDC Directory package listing · Drug for further processing
Code segments
11523 labeler · 8258 product · 1 package
Package marketed since
Dec 15, 2025
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 1152382581 1
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 11523-8258-1
Product NDC 11523-8258
11-digit billing NDC 11523825801
SPL Set ID 49644446-c1cf-97e5-e063-6294a90a09a4
DEA schedule Non-controlled
Marketing category DRUG FOR FURTHER PROCESSING
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-12-15
Dosage form CAPSULE
Substance DOCUSATE SODIUM
Why two NDCs? The FDA registers this code as 11523-8258-1 — 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 → 11523-8258-01. 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.

Clinical

🧪 What is this product?

This product is a capsule containing 100 mg of docusate sodium, a stool softener. Docusate sodium is typically used to help soften stool and make bowel movements easier for people experiencing constipation or difficulty passing stool. The listing indicates this is a bulk ingredient product intended for further processing rather than direct consumer use.

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 · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
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
11523-8258-01 You're viewing this Main listing 15000 CAPSULE in 1 BAG — — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Quality Choice Stool Softener 100 mg 63868-0585-01 Chain 100 capsules $0.022 — FDA listed —
good sense stool softener 100 mg 00113-0486-72 L. 60 capsules $0.022 — Discontinued —
Stool Softener Laxative 100 mg 70677-0034-01 Strategic 100 capsules $0.024 — Discontinued —
Stool Softener Laxative 100 mg 62011-0421-01 Strategic 100 capsules $0.024 — Discontinued —
Stool Softener Laxative 100 mg 70677-1095-01 Strategic 100 capsules $0.028 — Availability likely —
Docusate Sodium 100 mg 45802-0486-78 Padagis 100 capsules $0.028 — Availability likely —
Docusate Sodium 100 mg 60687-0129-01 American 1 capsule $0.028 — Availability likely —
Stool Softener Laxative 100 mg 70000-0091-01 CARDINAL 100 capsules $0.028 — Availability likely —
Stool Softener Laxative 100 mg 00904-7280-60 Major 100 capsules $0.028 — Availability likely —
Docusate sodium 100 mg 24689-0130-01 APNAR 100 capsules $0.028 — Availability likely —
Good Neighbor Stool Softener 100 mg 46122-0692-72 AmerisourceBergen 60 capsules $0.028 — Availability likely —
Docusate Sodium - Stool Softener Laxative 100 mg 00904-7183-61 Major 10 capsules $0.028 — Availability likely —
Colace 100 mg 67618-0101-01 Atlantis 100 capsules $0.306 — Availability likely —
Stool Softener Laxative 100 mg 11673-0678-16 TARGET 160 capsules — — FDA listed —
Stool Softener 100 mg 30142-0407-01 KROGER 100 capsules — — Discontinued —
Docusate Sodium 100 mg 50090-6140-01 A-S 100 capsules — — FDA listed —
Stool Softener Docusate Sodium 100 mg 54257-0902-02 Magno-Humphries, 100 capsules — — FDA listed —
Stool Softener 100 mg 57896-0401-01 Geri-Care 100 capsules — — FDA listed —
Stool Softener 100 mg 69168-0420-01 Allegiant 100 capsules — — FDA listed —
Stool Softener 100 mg 69168-0424-32 Allegiant 100 capsules — — FDA listed —
Topcare Stool Softener 100 mg 76162-0006-01 TopCo 100 capsules — — FDA listed —
Docusate Sodium 100 mg 76420-0225-30 Asclemed 30 capsules — — FDA listed —
Topcare Stool Softener 100 mg 76162-0761-25 TOPCO 25 capsules — — FDA listed —
FEVIA Constipation Control 100 mg 82706-0029-01 VIVUNT 50 capsules — — FDA listed —
Stool Softener Laxative 100 mg 00615-8557-39 NCS 30 capsules — — FDA listed —
docusate sodium 100 mg 00280-0071-01 Bayer 15000 capsules — — FDA listed —
Docusate Sodium 100 mg 10888-8156-01 Patheon 18000 capsules — — FDA listed —
Docusate Sodium 100 mg 61301-8002-05 AENOVA 20000 capsules — — FDA listed —
Stool Softener Laxative 100 mg 30142-0778-10 The 100 capsules — — Discontinued —
Stool Softener Laxative 100 mg 37808-0862-10 H 100 capsules — — FDA listed —
Stool Softener Laxative 100 mg 41163-0853-10 United 100 capsules — — FDA listed —
Docusate Sodium 100 mg 50090-7479-01 A-S 100 capsules — — FDA listed —
DOCUSATE SODIUM 100mg Two-Tone 100 mg 53345-0023-01 Humanwell 20000 capsules — — FDA listed —
DOCUSATE SODIUM 100mg Two-Tone 100 mg 53943-0250-10 Discount 100 capsules — — FDA listed —
Stool Softener Laxative 100 mg 55319-0561-10 Family 100 capsules — — FDA listed —
Stool Softener 100 mg 57896-0411-01 Geri-Care 100 capsules — — FDA listed —
Stool Softener Laxative 100 mg 59726-0141-01 P 1000 capsules — — FDA listed —
Docusate Sodium 100 mg 68071-3438-06 NuCare 60 capsules — — FDA listed —
Docusate Sodium 100 mg 81877-0840-90 Forreal 90 capsules — — FDA listed —
Stool Softener Laxative 100 mg 82804-0097-00 Proficient 100 capsules — — FDA listed —
Docusate Sodium 100 mg 10888-5129-01 Patheon 15000 capsules — — FDA listed —
Docusate Sodium 100 mg 10888-8162-01 Patheon 18000 capsules — — FDA listed —
Docusate Sodium 100 mg 10888-8210-01 Patheon 18000 capsules — — FDA listed —
Stool Softener Laxative 100 mg 11673-0341-16 TARGET 160 capsules — — FDA listed —
Stool Softener Laxative 100 mg 21130-0853-20 Safeway, 200 capsules — — FDA listed —
Stool Softener Laxative 100 mg 30142-0553-25 The 250 capsules — — FDA listed —
Docusate Sodium 100 mg 50090-5524-01 A-S 100 capsules — — FDA listed —
Stool Softener Laxative 100 mg 55910-0853-10 Dolgencorp, 100 capsules — — FDA listed —
Stool Softener Laxative 100 mg 59726-0142-01 P 1000 capsules — — FDA listed —
Winco Stool Softener 100 mg 67091-0366-10 WinCo 100 capsules — — FDA listed —
Docusate Sodium 100 mg 68071-2874-00 NuCare 100 capsules — — FDA listed —
Stool Softener 100 mg 69618-0086-01 Reliable 100 capsules — — FDA listed —
Docusate Sodium 100 mg 10888-8158-01 Patheon 18000 capsules — — FDA listed —
Stool Softener Laxative 100 mg 41163-0107-25 United 25 capsules — — FDA listed —
Stool Softener Laxative 100 mg 55910-0048-10 Dolgencorp, 100 capsules — — FDA listed —
Stool Softener Laxative 100 mg 55910-0968-40 Dolgencorp, 400 capsules — — FDA listed —
Stool Softener Laxative 100 mg 59726-0852-01 P 1000 capsules — — FDA listed —
Stool Softener Laxative 100 mg 63868-0638-25 QUALITY 250 capsules — — FDA listed —
Gentle Stool Softener 100 mg 00363-1179-25 WALGREEN 25 capsules — — FDA listed —
Stool Softener Laxative 100 mg 68391-0041-40 BJWC 400 capsules — — FDA listed —
Stool Softener Laxative 100 mg 00363-4100-20 Walgreens 200 capsules — — FDA listed —
Stool Softener Laxative 100 mg 69842-0782-10 CVS 100 capsules — — FDA listed —
Stool Softener Laxative 100 mg 69842-0794-10 CVS 100 capsules — — FDA listed —
Stool Softener 100 mg 71335-0294-00 Bryant 50 capsules — — FDA listed —
basic care stool softener 100 mg 72288-0486-78 Amazon.com 100 capsules — — FDA listed —
Stool Softener Laxative 100 mg 72476-0853-10 Care 100 capsules — — FDA listed —
Docusate Sodium 100 mg 72789-0399-30 PD-Rx 30 capsules — — FDA listed —
Quality Choice Stool Softener 100 mg 83324-0197-01 Chain 100 capsules — — FDA listed —
Docusate Sodium 100 mg 00904-7609-61 Major 1 capsule — — FDA listed —
Docusate Sodium 100 mg 61474-4092-01 Catalent 20000 capsules — — FDA listed —
Stool Softener Laxative 100 mg 37808-0853-30 H 300 capsules — — FDA listed —
Stool Softener Laxative 100 mg 49035-0385-50 EQUATE 50 capsules — — FDA listed —
Stool Softener Laxative 100 mg 49035-0526-14 EQUATE 140 capsules — — FDA listed —
Docusate Sodium 100 mg 55289-0493-12 PD-Rx 12 capsules — — FDA listed —
Stool Softener 100 mg 55910-0938-25 Dolgencorp, 25 capsules — — FDA listed —
Stool Softener 100 mg 55910-0939-20 Dolgencorp, 200 capsules — — FDA listed —
Stool Softener Laxative 100 mg 59726-0853-01 P 1000 capsules — — FDA listed —
Stool Softener 100 mg 68196-0853-60 Sam's 600 capsules — — FDA listed —
Stool Softener 100 mg 68391-0730-40 BJWC 400 capsules — — FDA listed —
Stool Softener Laxative 100 mg 00363-8530-20 Walgreens 200 capsules — — FDA listed —
Stool Softener 100 mg 69842-0861-10 CVS 100 capsules — — FDA listed —
Stool Softener Laxative 100 mg 69842-0893-30 CVS 30 capsules — — FDA listed —
Stool Softener Laxative 100 mg 72476-0041-10 Care 100 capsules — — FDA listed —
Stool Softener 100 mg 85111-0401-10 RMT 1000 capsules — — FDA listed —
Docusate Sodium 100 mg 10888-8157-01 Patheon 18000 capsules — — FDA listed —
Preferred Stool Softener 100 mg 10956-0621-00 Reese 100 capsules — — FDA listed —
Docusate Sodium 100 mg 73056-0017-18 Bioventure 18000 capsules — — FDA listed —
Stool Softener Laxative 100 mg 11673-0512-66 TARGET 160 capsules — — FDA listed —
Stool Softener Laxative 100 mg 30142-0451-25 The 250 capsules — — FDA listed —
Fleet 100 mg 00132-0402-25 C.B. 25 capsules — — FDA listed —
HEB Stool Softener 100 mg 37808-0222-52 H 100 capsules — — FDA listed —
Stool Softener 100 mg 37808-0582-01 HEB 100 capsules — — FDA listed —
Stool Softener Laxative 100 mg 41163-0241-10 United 100 capsules — — FDA listed —
Stool Softener 100 mg 50090-7167-01 A-S 100 capsules — — FDA listed —
exchange select stool softener 100 mg 55301-0486-78 Army 100 capsules — — FDA listed —
Phillips Stool Softener Bulk Docusate 100 mg 00280-1012-30 Bayer 30 capsules — — FDA listed —
Docusate Sodium 100 mg 66267-0888-30 NuCare 30 capsules — — FDA listed —
Docusate Sodium 100 mg 00363-8991-25 WALGREEN 25 capsules — — FDA listed —
Stool Softener Laxative 100 mg 69842-0579-30 CVS 30 capsules — — FDA listed —
Stool Softener Laxative 100 mg 72476-0862-25 Care 25 capsules — — FDA listed —
Docusate Sodium 100 mg 70120-0055-05 APL 4000 capsules — — FDA listed —
Stool Softener Laxative 100 mg 41163-0862-25 United 25 capsules — — FDA listed —
Stool Softener Laxative 100 mg 50804-0701-25 Good 25 capsules — — FDA listed —
Docusate Sodium 100 mg 68788-8658-03 Preferred 30 capsules — — FDA listed —
Stool Softener Laxative 100 mg 79903-0170-50 WALMART 50 capsules — — FDA listed —
Docusate Sodium 100 mg 61301-8001-05 AENOVA 20000 capsules — — FDA listed —
Stool Softener Laxative 100 mg 21130-0041-20 Safeway, 200 capsules — — FDA listed —
Stool Softener 100 mg 37808-0580-01 HEB 100 capsules — — FDA listed —
Dulcolax Stool Softener 100 mg 41167-0221-02 Chattem, 25 capsules — — FDA listed —
DOCUSATE SODIUM 100mg 100 mg 53345-0029-01 Humanwell 20000 capsules — — FDA listed —
Stool Softener Laxative 100 mg 63941-0853-10 Best 100 capsules — — FDA listed —
Stool Softener Laxative 100 mg 68071-3784-00 NuCare 100 capsules — — FDA listed —
Docusate Sodium 100 mg 68196-0995-64 Sam's 600 capsules — — FDA listed —
Stool Softener 100 mg 68788-8919-01 Preferred 100 capsules — — FDA listed —
Stool Softener Laxative 100 mg 71335-9731-00 Bryant 18 capsules — — FDA listed —
Stool Softener 100 mg 72162-2255-01 Bryant 100 capsules — — FDA listed —
Docusate Sodium 100 mg 10888-8163-01 Patheon 18000 capsules — — FDA listed —
docusate sodium 100 mgthis 11523-8258-01 Bayer 15000 capsules — — FDA listed —
Stool Softener Laxative 100 mg 11673-0853-16 TARGET 160 capsules — — FDA listed —
Stool Softener Laxative 100 mg 36800-0638-10 TOP 100 capsules — — FDA listed —
Stool Softener 100 mg 36800-0651-25 TOP 25 capsules — — FDA listed —
Dulcolax Pink Stool Softener 100 mg 41167-0281-01 Chattem, 25 capsules — — FDA listed —
Stool Softener 100 mg 55910-0762-50 Dolgencorp, 50 capsules — — FDA listed —
Docusate Sodium 100 mg 63187-0476-00 Proficient 100 capsules — — FDA listed —
Stool Softener Laxative 100 mg 69842-0317-30 CVS 30 capsules — — FDA listed —
Stool Softener 100 mg 69842-0862-10 CVS 100 capsules — — Discontinued —
Topcare Stool Softener 100 mg 76162-0777-99 TOPCO 250 capsules — — FDA listed —
HEB Stool Softener 100 mg 37808-0457-52 H 100 capsules — — FDA listed —
Docusate Sodium 100 mg 53345-0008-01 Humanwell 20000 capsules — — FDA listed —
Stool Softener Laxative 100 mg 63981-0853-40 Costco 400 capsules — — FDA listed —
Stool Softener Regular Strength 100 mg 68196-0998-60 Sam's 600 capsules — — FDA listed —
Stool Softener Laxative 100 mg 00363-4202-30 Walgreens 30 capsules — — FDA listed —
Stool Softener Laxative 100 mg 68788-8501-01 Preferred 100 capsules — — FDA listed —
Stool Softener Laxative 100 mg 00363-7111-10 Walgreens 25 capsules — — FDA listed —
Stool Softener 100 mg 00363-9944-20 Walgreen 30 capsules — — FDA listed —
Stool Softener Laxative 100 mg 79481-0853-01 Meijer 100 capsules — — FDA listed —
Docusate sodium 100 mg 51344-0844-00 MEDGEL 1000 capsules — — FDA listed —
Stool Softener Laxative 100 mg 51316-0107-10 CVS 100 capsules — — FDA listed —
DOCUSATE SODIUM 100mg Two-Tone 100 mg 53345-0018-01 Humanwell 20000 capsules — — FDA listed —
Docusate Sodium - Stool Softener Laxative 100 mg 55154-3369-00 Cardinal 1 capsule — — FDA listed —
Stool Softener Laxative 100 mg 56062-0241-10 Publix 100 capsules — — FDA listed —
Winco Stool Softener 100 mg 67091-0380-25 WinCo 25 capsules — — FDA listed —
Gentle Stool Softener 100 mg 00363-1172-25 WALGREEN 25 capsules — — FDA listed —
Stool Softener Laxative 100 mg 68391-0853-40 BJWC 400 capsules — — FDA listed —
Stool Softener 100 mg 00363-8540-30 Walgreens 30 capsules — — FDA listed —
Stool Softener Laxative 100 mg 72476-0107-25 Care 25 capsules — — FDA listed —
Stool Softener Laxative 100 mg 30142-0280-10 The 100 capsules — — FDA listed —
stool softener 100 mg 72288-0035-78 Amazon.com 100 capsules — — FDA listed —
Docusate Sodium 100 mg 55154-0578-00 Cardinal 1 capsule — — FDA listed —
MiraSOFT Stool Softener 100 mg 11523-8259-03 Bayer 30 capsules — — FDA listed —
HyVee Regular Strength Stool Softener SOFTGEL 100 mg 42507-0108-01 HyVee 100 capsules — — FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
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

🏛️
2025
On the market since
Dec 2025
📍
2026
Currently FDA-listed
1 year listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

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.

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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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

LabelerBayer HealthCare LLC.
Labeler code11523
First marketedDec 2025
Product typeDrug For Further Processing
Portfolio240 products on file

More NDCs from Bayer HealthCare LLC. labeler code 11523

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 FDA label FDA SPL

The complete FDA label for this product, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
📄 FDA label
📄 FDA label 19 words ▾

No FDA label is on file for this product yet. Labels load from openFDA / DailyMed and refresh weekly.

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

Listed for further processing / repackaging

What "drug for further processing" means

FDA lists this package under the "drug for further processing" marketing category: Bayer HealthCare LLC. supplies it to other companies for further processing or repackaging (blister cards that are later repackaged or co-packaged are a common example). The units themselves are a finished dosage form — which is why pricing or Medicaid data can still appear — but this exact package code may not be the presentation a retail pharmacy dispenses.

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 — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Drug For Further Processing". Products approved under an application carry an NDA, ANDA, or BLA number.
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 Bayer HealthCare LLC.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Bayer HealthCare LLC. 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.
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.
← 11523-7341-01 · Bayer 11523-8259-03 · Bayer →
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.