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Cromolyn Sodium 40 mg/mL Solution/ Drops — NDC 17478-0291-11 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Cromolyn Sodium 40 mg/mL Solution/ Drops — NDC 17478-291-11 (Billing 17478-0291-11)

by Akorn · 1 BOTTLE, DROPPER in 1 CARTON / 10 mL in 1 BOTTLE, DROPPER

This is a package of Cromolyn Sodium 40 mg/mL Solution/ Drops from Akorn, no longer marketed, no longer in the FDA NDC Directory; retail pharmacies pay about $0.5730 per mL (NADAC). It is this product's only package size.

NDC 17478-0291-11
🏷️ FDA NDC (as labeled) 17478-291-11 billing pads the product segment with a zero
Rx only Generic Discontinued Non-controlled ⚠ Inactivated by FDA ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Jul 14, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

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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 17478-291-11 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
17478 labeler · 291 product · 11 package
Barcode (UPC-A, from the NDC)
3 1747829111 4
FDA record last changed
Jul 14, 2026
⚠️
Excluded from the active FDA NDC Directory. FDA inactivated this product’s listing record, so it is excluded from the active NDC Directory. The listing was last certified through Dec 2023. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 17478-291-11
Product NDC 17478-291
11-digit billing NDC 17478029111
NCPDP billing unit ML — per mL (volume)
Application # ANDA074706
SPL Set ID e604ed4d-d8a7-4f65-a386-b4bd6137d987
Established class (EPC) Decreased Histamine Release [PE], Mast Cell Stabilizer
DEA schedule Non-controlled
Marketing category ANDA
Marketing status Discontinued
FDA listing status Inactivated by FDA (certified through Dec 2023)
Route OPHTHALMIC
Dosage form SOLUTION/ DROPS
Substance CROMOLYN SODIUM

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GCN Seq No 044694
GCN 69069
HICL code 004526
Ingredient (HICL) Cromolyn Sodium
HIC1 code Q
Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code Q6
Therapeutic class — intermediate (HIC2) Ophthalmic Preparations
HIC3 code Q6U
Therapeutic class — specific (HIC3) Eye Mast Cell Stabilizers
AHFS code 48:10.32.00
AHFS class Mast-Cell Stabilizers
FDB label name CROMOLYN 4% EYE DROPS
FDB brand name Cromolyn Sodium
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 044694
  • GCN: 69069
  • HICL (First Databank): 004526
  • AHFS class code: 48:10.32.00
Why two NDCs? The FDA registers this code as 17478-291-11 — a 5-3-2 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 product segment → 17478-0291-11. 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

Label name CROMOLYN 4% EYE DROPS Ingredient Cromolyn Sodium
📗 Our plain-language guide HelloPharmacist
  • It's actually for a specific group of recurring seasonal allergic eye conditions called vernal keratoconjunctivitis, vernal conjunctivitis, and vernal keratitis. 'Vernal' means the...
  • What exactly is this eye drop treating — is it just regular eye allergies?
  • Most people start to notice less itching, tearing, redness, and discharge within a few days of using the drops consistently. That said, for some people it can take up to six weeks...
  • How long before these drops actually start helping?
📖 Read our full Cromolyn Ophthalmic guide →
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 mLPer package
Retail pharmacies payNADAC · weekly $0.573 $5.73 / 10 ml
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.
NADAC price history (per mL) — tap or hover for the price & month
Dec 2021 Mar 2022 Jul 2022 Nov 2022 $0.621 $0.521
▼ Down 8% over the last 12 months.
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
17478-0291-11 You're viewing this Main listing 1 BOTTLE, DROPPER in 1 CARTON / 10 mL in 1 BOTTLE, DROPPER 1998-04-29 — Inactivated by FDA

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Cromolyn Sodium 40 mg/mLthis 17478-0291-11 Akorn 1 bottle $0.573 — Discontinued —
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

📍
2026
Currently FDA-listed
listed with the FDA
🔓
·
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.

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.

🧪 Avoiding an ingredient? See Cromolyn Ophthalmic inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

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

LabelerAkorn
Application holderSCIEGEN PHARMACEUTICALS INC
FDA applicationANDA074706 (ANDA)
Labeler code17478
Product typeHuman Prescription Drug
Portfolio3 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.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications 🤒 Adverse Reactions 🤰 Pregnancy 🧒 Pediatric Use 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients ⚠️ Precautions 🍼 Nursing Mothers 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Patient Package Insert 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 20 words ▾

INDICATIONS AND USAGE Cromolyn Sodium Ophthalmic Solution is indicated in the treatment of vernal keratoconjunctivitis, vernal conjunctivitis, and vernal keratitis.

⏱️ Dosage and Administration 111 words ▾

DOSAGE AND ADMINISTRATION The dose is 1 or 2 drops in each eye 4 to 6 times a day at regular intervals. One drop contains approximately 1.6 mg cromolyn sodium. Patients should be advised that the effect of Cromolyn Sodium Ophthalmic Solution therapy is dependent upon its administration at regular intervals, as directed.

Symptomatic response to therapy (decreased itching, tearing, redness, and discharge) is usually evident within a few days, but longer treatment for up to six weeks is sometimes required. Once symptomatic improvement has been established, therapy should be continued for as long as needed to sustain improvement. If required, corticosteroids may be used concomitantly with Sodium Chloride Ophthalmic Solution.

⛔ Contraindications 24 words ▾

CONTRAINDICATIONS Cromolyn Sodium Ophthalmic Solution is contraindicated in those patients who have shown hypersensitivity to cromolyn sodium or to any of the other ingredients.

🤒 Adverse Reactions 79 words ▾

ADVERSE REACTIONS The most frequently reported adverse reaction attributed to the use of cromolyn sodium, on the basis of reoccurrence following readministration, is transient ocular stinging or burning upon instillation. The following adverse reactions have been reported as infrequent events. It is unclear whether they are attributed to the drug: Conjunctival injection; watery eyes; itchy eyes; dryness around the eye; puffy eyes; eye irritation; and styes.

Immediate hypersensitivity reactions have been reported rarely and include dyspnea, edema, and rash.

🤰 Pregnancy 189 words ▾

Pregnancy Teratogenic Effects: Pregnancy Category B. Reproduction studies with cromolyn sodium administered subcutaneously to pregnant mice and rats at maximum daily doses of 540 mg/kg (1620 mg/m 2 ) and 164 mg/kg (984 mg/m 2 ), respectively, and intravenously to rabbits at a maximum daily dose of 485 mg/kg (5820 mg/m 2 ) produced no evidence of fetal malformation. These doses represent approximately 57, 35, and 205 times the maximum daily human dose, respectively, on a mg/m 2 basis.

Adverse fetal effects (increased resorption and decreased fetal weight) were noted only at the very high parenteral doses that produced maternal toxicity. There are, however, no adequate and well controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Cromolyn Sodium Ophthalmic Solution is administered to a nursing woman. Pediatric Use: Safety and effectiveness in children below the age of 4 years have not been established.

🧒 Pediatric Use 17 words ▾

Pediatric Use: Safety and effectiveness in children below the age of 4 years have not been established.

🧬 Clinical Pharmacology 206 words ▾

CLINICAL PHARMACOLOGY In vitro and in vivo animal studies have shown that cromolyn sodium inhibits the degranulation of sensitized mast cells which occurs after exposure to specific antigens. Cromolyn sodium acts by inhibiting the release of histamine and SRS-A (slow-reacting substance of anaphylaxis) from the mast cell. Another activity demonstrated in vitro is the capacity of cromolyn sodium to inhibit the degranulation of non-sensitized rat mast cells by phospholipase A and the subsequent release of chemical mediators.

Another study showed that cromolyn sodium did not inhibit the enzymatic activity of released phospholipase A on its specific substrate. Cromolyn sodium has no intrinsic vasoconstrictor, antihistamine, or anti-inflammatory activity. Cromolyn sodium is poorly absorbed.

When multiple doses of cromolyn sodium ophthalmic solution are instilled into normal rabbit eyes, less than 0.07% of the administered dose of cromolyn sodium is absorbed into the systemic circulation (presumably by way of the eye, nasal passages: buccal cavity and gastrointestinal tract). Trace amounts (less than 0.01%) of the cromolyn sodium dose penetrate into the aqueous humor and clearance from this chamber is virtually complete within 24 hours after treatment is stopped. In normal volunteers, analysis of drug excretion indicates that approximately 0.03% of cromolyn sodium is absorbed following administration to the eye.

📦 How Supplied / Storage and Handling 77 words ▾

HOW SUPPLIED Cromolyn Sodium Ophthalmic Solution USP 4% is supplied as 10 mL of solution in an opaque polyethylene bottle with a controlled dropper tip. NDC 17478-291-11 Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light-store in original carton.

Keep tightly closed. Keep out of reach of children. Akorn Manufactured By: AKORN, INC.

Lake Forest, IL 60045 CR00N Rev. 06/16 PHARMACIST – DETACH HERE AND GIVE INSTRUCTIONS TO PATIENTS

📦 Storage and Handling 50 words ▾

Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light-store in original carton. Keep tightly closed. Keep out of reach of children. Akorn Manufactured By: AKORN, INC. Lake Forest, IL 60045 CR00N Rev. 06/16 PHARMACIST – DETACH HERE AND GIVE INSTRUCTIONS TO PATIENTS

📋 Description 73 words ▾

DESCRIPTION Cromolyn Sodium Ophthalmic Solution USP, 4% is a clear, colorless, sterile solution intended for topical ophthalmic use. Cromolyn Sodium is represented by the following structural formula: Chemical Name: disodium 5-5' - [(2-hydroxytrimethylene)dioxy] bis [4-oxo-4H-1- benzopyran -2-carboxylate]. Pharmacologic Category: Mast cell stabilizer.

Each mL contains: Active: Cromolyn sodium 40 mg (4%); Inactives: Edetate disodium 0.1% and Water for Injection. It has a pH of 4.0 to 7.0; Preservative: Benzalkonium chloride 0.01%. Structural Formula

💬 Information for Patients 54 words ▾

Information for Patients: Patients should be advised to follow the patient instructions listed on the Information for Patient's sheet. Users of contact lenses should refrain from wearing lenses while exhibiting the signs and symptoms of vernal keratoconjunctivitis, vernal conjunctivitis, or vernal keratitis. Do not wear contact lenses during treatment with Cromolyn Sodium Ophthalmic Solution.

⚠️ Precautions ~2 min read ▾

PRECAUTIONS General: Patients may experience a transient stinging or burning sensation following application of Cromolyn Sodium Ophthalmic Solution. The recommended frequency of administration should not be exceeded (see DOSAGE AND ADMINISTRATION ). Information for Patients: Patients should be advised to follow the patient instructions listed on the Information for Patient's sheet.

Users of contact lenses should refrain from wearing lenses while exhibiting the signs and symptoms of vernal keratoconjunctivitis, vernal conjunctivitis, or vernal keratitis. Do not wear contact lenses during treatment with Cromolyn Sodium Ophthalmic Solution. Carcinogenesis, Mutagenesis, and Impairment of Fertility: Long term studies of Cromolyn Sodium in mice (12 months intraperitoneal administration at doses up to 150 mg/kg three days per week): hamsters (intraperitoneal administration at doses up to 52.6 mg/kg three days per week for 15 weeks followed by 17.5 mg/kg three days per week for 37 weeks), and rats (18 months subcutaneous administration at doses up to 75 mg/kg six days per week) showed no neoplastic effects.

The average daily maximum dose levels administered in these studies were 192.9 mg/m 2 for mice, 47.2 mg/m 2 for hamsters and 385.8 mg/m 2 for rats. These doses correspond to approximately 6.8,1.7, and 14 times the maximum daily human dose of 28 mg/m 2 . Cromolyn Sodium showed no mutagenic potential in the Ames Salmonella /microsome plate assays, mitotic gene conversion in Saccharomyces cerevisiae and in an In vitro cytogenetic study in human peripheral lymphocytes.

No evidence of impaired fertility was shown in laboratory reproduction studies conducted subcutaneously in rats at the highest doses tested, 175 mg/kg/day (1050 mg/m 2 ) in males and 100 mg/kg/day (600 mg/m 2 ) in females. These doses are approximately 37 and 21 times the maximum daily human dose, respectively, based on mg/m 2 . Pregnancy Teratogenic Effects: Pregnancy Category B.

Reproduction studies with cromolyn sodium administered subcutaneously to pregnant mice and rats at maximum daily doses of 540 mg/kg (1620 mg/m 2 ) and 164 mg/kg (984 mg/m 2 ), respectively, and intravenously to rabbits at a maximum daily dose of 485 mg/kg (5820 mg/m 2 ) produced no evidence of fetal malformation. These doses represent approximately 57, 35, and 205 times the maximum daily human dose, respectively, on a mg/m 2 basis. Adverse fetal effects (increased resorption and decreased fetal weight) were noted only at the very high parenteral doses that produced maternal toxicity.

There are, however, no adequate and well controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Nursing Mothers: It is not known whether this drug is excreted in human milk.

Because many drugs are excreted in human milk, caution should be exercised when Cromolyn Sodium Ophthalmic Solution is administered to a nursing woman. Pediatric Use: Safety and effectiveness in children below the age of 4 years have not been established.

🍼 Nursing Mothers 37 words ▾

Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Cromolyn Sodium Ophthalmic Solution is administered to a nursing woman.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 207 words ▾

Carcinogenesis, Mutagenesis, and Impairment of Fertility: Long term studies of Cromolyn Sodium in mice (12 months intraperitoneal administration at doses up to 150 mg/kg three days per week): hamsters (intraperitoneal administration at doses up to 52.6 mg/kg three days per week for 15 weeks followed by 17.5 mg/kg three days per week for 37 weeks), and rats (18 months subcutaneous administration at doses up to 75 mg/kg six days per week) showed no neoplastic effects. The average daily maximum dose levels administered in these studies were 192.9 mg/m 2 for mice, 47.2 mg/m 2 for hamsters and 385.8 mg/m 2 for rats.

These doses correspond to approximately 6.8,1.7, and 14 times the maximum daily human dose of 28 mg/m 2 . Cromolyn Sodium showed no mutagenic potential in the Ames Salmonella /microsome plate assays, mitotic gene conversion in Saccharomyces cerevisiae and in an In vitro cytogenetic study in human peripheral lymphocytes. No evidence of impaired fertility was shown in laboratory reproduction studies conducted subcutaneously in rats at the highest doses tested, 175 mg/kg/day (1050 mg/m 2 ) in males and 100 mg/kg/day (600 mg/m 2 ) in females.

These doses are approximately 37 and 21 times the maximum daily human dose, respectively, based on mg/m 2 .

📄 Patient Package Insert ~1 min read ▾

Information for the Patient Cromolyn Sodium Ophthalmic Solution USP, 4% Sterile It is important to use Cromolyn Sodium Ophthalmic Solution regularly , as directed by your physician. Thoroughly wash your hands. Remove safety seal ( Figure 1 ).

Remove cap ( Figure 2 ). Sit or stand comfortably, with your head tilted back ( Figure 3 ). Open eyes, look up, and draw the lower lid of your eye down gently with your index finger ( Figure 4 ).

Hold the Cromolyn Sodium Ophthalmic Solution bottle upside down. Place dropper tip as close as possible to the lower eyelid and gently squeeze out the prescribed number of drops ( Figure 5 ). Do not touch the eye or eyelid with the dropper tip.

Blink a few times to make sure the eye is covered with the solution. Close your eye and remove any excess solution with a clean tissue. Repeat process in the other eye.

Special Tips: Avoid placing Cromolyn Sodium Ophthalmic Solution directly on the cornea (the area just over the pupil), because it is especially sensitive. You will find the administration of eye drops more comfortable if you place the drops just inside the lower eyelid as shown in Figure 5 on the previous page. To avoid contamination of the solution, do not touch dropper tip to the eye, fingers, or any other surface.

Replace cap after use. It is recommended that any remaining contents be discarded after the treatment period prescribed by your physician. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Protect from light — store in original carton. Keep tightly closed and out of the reach of children. Do not use with any other ocular medication unless directed by your physician.

Do not wear contact lenses during treatment with Cromolyn Sodium Ophthalmic Solution. Akorn Manufactured By: AKORN, INC. Lake Forest, IL 60045 Rev.

06/16 Figure 1 Figure 2 Figure 3 Figure 4 Figure 5

📄 Package Label / Principal Display Panel 64 words ▾

Principal Display Panel Text for Container Label: NDC 17478-291-11 Cromolyn Sodium Ophthalmic Solution, USP 4% Rx only Sterile 10 mL FOR OPHTHALMIC USE ONLY Principal Display Panel Text for Container Label

Principal Display Panel Text for Carton Label: NDC 17478-291-11 Cromolyn Sodium Ophthalmic Solution, USP 4% FOR OPHTHALMIC USE ONLY Sterile 10 mL Rx only Akorn Logo Principal Display Panel Text for Carton Label

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 Cromolyn Sodium — the program that covers self-administered drugs. 7 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 Cromolyn Sodium. 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
$3.73M
Claims incl. refills
26.3K
Beneficiaries
18.7K
Spend / beneficiary
$199.42
Spend / claim
$142.02
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 No longer marketed (per FDA listing data)
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) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) ✓ Available
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

What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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.
Who lists this product with the FDA?
Akorn 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.
← 17445-6034-00 · Sigma-Aldrich 17504-0007-02 · Lonza →
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.