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Hydrocortisone Acetate 25 mg Suppository, 12 suppositories — NDC 24689-0102-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Hydrocortisone Acetate 25 mg Suppository, 12 suppositories — NDC 24689-102-01 (Billing 24689-0102-01)

by APNAR PHARMA LP · 12 SUPPOSITORY in 1 CARTON

This is a package of 12 suppositories of Hydrocortisone Acetate 25 mg Suppository from APNAR PHARMA LP, marketed since Oct 2021 and currently FDA-listed; retail pharmacies pay about $1.10 per suppositorie (NADAC). It is this product's only package size.

NDC 24689-0102-01
🏷️ FDA NDC (as labeled) 24689-102-01 billing pads the product segment with a zero
Rx only On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 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 24689-102-01 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
24689 labeler · 102 product · 01 package
Package marketed since
Oct 1, 2021
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Billing quantity
12 EA per package
Barcode (UPC)
0324689102016, 0324689103013
Medicaid fills, this package
197 prescriptions in the last four reported quarters
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 24689-102-01
Product NDC 24689-102
11-digit billing NDC 24689010201
NCPDP billing unit EA — each (per item)
RxCUI 1291082, 1291085
UNII 3X7931PO74
UPC 0324689102016, 0324689103013
SPL Set ID cb60f2a6-8bab-c0f9-e053-2a95a90a422a
Established class (EPC) Corticosteroid
Mechanism of action Corticosteroid Hormone Receptor Agonists
DEA schedule Non-controlled
Marketing category UNAPPROVED DRUG OTHER
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2021-10-01
Route RECTAL
Dosage form SUPPOSITORY
Substance HYDROCORTISONE ACETATE

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

GPI-14 89100010105230
GPI class Hydrocortisone Acetate
GCN Seq No 006858
GCN 27941
HICL code 002863
Ingredient (HICL) Hydrocortisone Acetate
HIC1 code Q
Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code Q3
Therapeutic class — intermediate (HIC2) Anal-Rectal Preparations
HIC3 code Q3A
Therapeutic class — specific (HIC3) Rectal Preparations
AHFS code 84:06.08.00
AHFS class Corticosteroids (Skin, Mucous Membrane)
FDB label name HYDROCORTISONE AC 25 MG SUPP
FDB brand name Hydrocortisone Acetate
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 006858
  • GCN: 27941
  • GPI-14 (Medi-Span): 89100010105230
  • HICL (First Databank): 002863
  • AHFS class code: 84:06.08.00
  • RxCUI (RxNorm): 1291082
Why two NDCs? The FDA registers this code as 24689-102-01 — 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 → 24689-0102-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Corticosteroid class.

Pharmacologic class Corticosteroid
Drug family (ATC) Corticosteroids, moderately potent (group II), Corticosteroids, potent (group III), Corticosteroids for local oral treatment
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.

Clinical

Label name HYDROCORTISONE AC 25 MG SUPP Ingredient Hydrocortisone Acetate
📗 Our plain-language guide HelloPharmacist
  • It depends on the product. Tablets and oral granules are used for adrenal insufficiency, among other conditions. Injections are used for severe allergic states and skin diseases. R...
  • Don't stop it suddenly if you take it for adrenal insufficiency. Stopping abruptly can cause adrenal crisis, which can be fatal. Talk to your prescriber before making any changes.
  • Common ones are fluid retention, higher blood pressure, changes in blood sugar, mood changes, bigger appetite and weight gain. Call your doctor for signs of infection, vision chang...
  • Grapefruit juice and some antifungals and antibiotics can raise hydrocortisone levels. Some seizure medicines and rifampicin can lower them. Tell me about any diabetes medicines, w...
📖 Read our full Hydrocortisone guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
8
Nutrient depletion considerations

Hydrocortisone may be associated with lower levels of 8 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Hydrocortisone 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 eaPer package
Retail pharmacies payNADAC · weekly $1.101 $13.21 / 12 suppositories
Medicaid paysCMS SDUD · 12 mo $1.53 $18.30 / 12 suppositories
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per ea) — tap or hover for the price & month
Jul 2025 $1.101 $1.101
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
24689-0102-01 You're viewing this Main listing 12 SUPPOSITORY in 1 CARTON 2021-10-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Hydrocortisone Acetate 25 mgthis 24689-0102-01 APNAR 12 suppositories $1.101 — FDA listed —
Hydrocortisone Acetate 25 mg 00574-7090-12 Padagis 12 suppositories — — FDA listed —
Anucort-Hc 25 mg 00713-0503-01 Cosette 100 suppositories — — FDA listed —
Hydrocortisone Acetate 25 mg 00904-7340-12 Major 12 suppositories — — FDA listed —
Hydrocortisone Acetate 25 mg 10135-0751-12 Marlex 12 suppositories — — FDA listed —
Hemmorex-HC 25 mg 16477-0201-12 Laser 12 suppositories — — FDA listed —
Hydrocortisone Acetate 25 mg 16571-0676-21 Rising 12 suppositories — — FDA listed —
Hydrocortisone Acetate 25 mg 39328-0029-12 Patrin 12 suppositories — — FDA listed —
Hydrocortisone Acetate 25 mg 50090-6331-00 A-S 12 suppositories — — FDA listed —
Hydrocortisone Acetate 25 mg 50268-0411-01 AvPAK 100 suppositories — — FDA listed —
Hydrocortisone Acetate 25 mg 51407-0665-12 Golden 12 suppositories — — FDA listed —
Hydrocortisone Acetate 25 mg 63629-2530-01 Bryant 12 suppositories — — FDA listed —
Anusol HC 25 mg 65649-0411-12 Salix 12 suppositories — — FDA listed —
Hydrocortisone Acetate 25 mg 68071-2259-02 NuCare 12 suppositories — — FDA listed —
Hydrocortisone Acetate 25 mg 69367-0243-12 Westminster 12 suppositories — — FDA listed —
Hydrocortisone Acetate 25 mg 70752-0169-02 QUAGEN 12 suppositories — — FDA listed —
Hydrocortisone Acetate 25 mg 71205-0976-12 Proficient 12 suppositories — — FDA listed —
Hydrocortisone Acetate 25 mg 75834-0147-12 Nivagen 12 suppositories — — FDA listed —
Hydrocortisone Acetate 25 mg 82568-0150-01 AARNA 12 suppositories — — FDA listed —
Hydrocortisone Acetate 25 mg 68788-4190-01 Preferred 12 suppositories — — 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

🏛️
2021
On the market since
Oct 2021
📍
2026
Currently FDA-listed
5 years 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.

What it looks like

Color white
ShapeBullet
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.

🧪 Avoiding an ingredient? See Hydrocortisone 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.

A current SPL was checked, but it does not contain a structured or narrative inactive-ingredient list for this product. This does not mean the product has no inactive ingredients.
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

LabelerAPNAR PHARMA LP
Labeler code24689
First marketedOct 2021
Product typeHuman Prescription Drug
Portfolio28 products on file

More NDCs from APNAR PHARMA LP labeler code 24689

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 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients ⚠️ Precautions 🔒 Drug Abuse and Dependence 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 36 words ▾

INDICATIONS AND USAGE Hydrocortisone acetate suppositories are indicated for use in inflamed hemorrhoids, post-irradiation (factitial) proctitis; as an adjunct in the treatment of chronic ulcerative colitis; cryptitis; and other inflammatory conditions of anorectum and pruritus ani.

⏱️ Dosage and Administration 116 words ▾

DOSAGE AND ADMINISTRATION FOR RECTAL ADMINISTRATION . Detach one suppository from strip of suppositories. Hold suppository upright and carefully separate tabs at top opening and pull downward from the pointed end to expose the suppository.

Remove the suppository from the pocket. Avoid excessive handling of suppository which is designed to melt at body temperature. Insert one suppository rectally, pointed end first.

Insert one suppository in the rectum twice daily, morning and night for two weeks, in nonspecific proctitis. In more severe cases, one suppository three times a day or two suppositories twice daily. In factitial proctitis, the recommended duration of therapy is six to eight weeks or less, according to the response of the individual case.

⛔ Contraindications 22 words ▾

CONTRAINDICATIONS Hydrocortisone acetate suppositories are contraindicated in those patients having a history of hypersensitivity to hydrocortisone acetate or any of the components.

🤒 Adverse Reactions 36 words ▾

ADVERSE REACTIONS The following local adverse reactions have been reported with hydrocortisone acetate suppositories: burning, itching, irritation, dryness, folliculitis, hypopigmentation, allergic contact dermatitis, secondary infection. To report SUSPECTED ADVERSE REACTIONS, contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🤰 Pregnancy 144 words ▾

PREGNANCY CATEGORY C In laboratory animals, topical steroids have been associated with an increase in the incidence of fetal abnormalities when gestating females have been exposed to rather low dosage levels. There are no adequate and well controlled studies in pregnant women. Hydrocortisone acetate suppositories should only be used during pregnancy if the potential benefit justifies the risk to the fetus.

Drugs of this class should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time. It is not known whether this drug is excreted in human milk and because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from hydrocortisone acetate suppositories, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

🆘 Overdosage 11 words ▾

OVERDOSAGE If signs and symptoms of systemic overdosage occur, discontinue use.

🧬 Clinical Pharmacology 45 words ▾

CLINICAL PHARMACOLOGY In normal subjects, about 26% of hydrocortisone acetate is absorbed when the suppository is applied to the rectum. Absorption of hydrocortisone acetate may vary across abraded or inflamed surfaces. Topical steroids are primarily effective because of their anti- inflammatory, anti-pruritic and vasoconstrictive action.

📦 How Supplied / Storage and Handling 14 words ▾

HOW SUPPLIED Boxes of 12 suppositories NDC 24689-102-01 Boxes of 12 suppositories NDC 24689-103-01

📦 Storage and Handling 142 words ▾

STORAGE AND HANDLING Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature]. Excursions permitted to 15°- 30°C (59°-86°F). Store away from heat.

Protect from freezing. Avoid contact with eyes. KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN .

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately. PHARMACIST : This product is not an Orange Book rated product, therefore all prescriptions using this product shall be subject to state and federal statutes as applicable. This product has not been subjected to FDA therapeutic or other equivalency testing.

There are no claims of bioequivalence or therapeutic equivalence. Each person recommending a prescription substitution using this product shall make such recommendation based on his/her professional knowledge and opinion, upon evaluating the active ingredients, inactive ingredients, excipients and chemical information contained within the enclosed prescribing information.

📋 Description 37 words ▾

DESCRIPTION Hydrocortisone Acetate is a corticosteroid designated chemically as pregn-4-ene 3, 20-dione, 21- (acetyloxy)-11,17-dihydroxy-(11ß) with the following structural formula: Each rectal suppository contains hydrocortisone acetate, 25 mg in a specially blended hydrogenated vegetable oil base. structural formula

💬 Information for Patients 17 words ▾

INFORMATION FOR PATIENTS Staining of fabric may occur with use of the suppository. Precautionary measures are recommended.

⚠️ Precautions 63 words ▾

PRECAUTIONS Do not use hydrocortisone acetate suppositories unless adequate proctologic examination is made. If irritation develops, the product should be discontinued and appropriate therapy instituted. In the presence of an infection, the use of an appropriate antifungal or antibacterial agent should be instituted.

If a favorable response does not occur promptly, hydrocortisone acetate should be discontinued until the infection has been adequately controlled.

🔒 Drug Abuse and Dependence 19 words ▾

DRUG ABUSE AND DEPENDENCE Drug abuse and dependence have not been reported in patients treated with hydrocortisone acetate suppositories.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 18 words ▾

Carcinogenesis No long term studies in animals have been performed to evaluate the carcinogenic potential of corticosteroid suppositories.

📄 Package Label / Principal Display Panel 49 words ▾

25mg- Suppositories carton NDC 24689-102-01 Rx Only Hydrocortisone Acetate Suppositories 25 mg FOR RECTAL USE ONLY APNAR PHARMA LP 12 Suppositories Unit Dose 25mg-Suppositories Carton

30mg-Suppositories Carton NDC 24689-103-01 Rx Only Hydrocortisone Acetate Suppositories 30 mg FOR RECTAL USE ONLY APNAR PHARMA LP 12 Suppositories Unit Dose 30mg-Suppositories carton

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

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
197
Units reimbursed last 4 qtrs
4.6K
Gross reimbursed last 4 qtrs
$7K
Avg / prescription
$35.52
Avg / unit
$1.5250
Latest quarter Q1 2026
0Rx
Medicaid pays / ea
$1.5250
gross reimbursed
vs
NADAC / ea
$1.1008
acquisition cost
=
Spread
+$0.4242
+39% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
100% FFS
Fee-for-service · 197 Rx Managed care · 0 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: 2,119 units · 10.8 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: 2,470 units · 6.3 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
6.310.8
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 New York 10.8 /100k
2 California 6.3 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

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

Medicare Part D (outpatient prescription) spending for Hydrocortisone Acetate — the program that covers self-administered drugs. 1 manufacturer.
⚠️ 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 Hydrocortisone Acetate. 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
$497.1K
Claims incl. refills
345
Beneficiaries
236
Spend / beneficiary
$2,106.25
Spend / claim
$1,440.80
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 HYDROCORTISONE ACETATE — the ingredient across all brands.

Top reported reactions

Fatigue7,477
Condition Aggravated6,634
Rash6,313
Pain6,011
Nausea5,718
Arthralgia5,320
Diarrhoea5,315

Age at onset

Neonate341
Infant320
Child1,078
Adolescent717
Adult8,798
Elderly3,694

Reporter sex

73,228 reports
Male · 41%
Female · 59%
Unknown · 0%

Serious outcomes

Death10,771
Life-threatening9,680
Disabling6,943
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 7,147 0
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.

About this NDC listing & data coverage

Finished prescription product Marketed without an FDA application

Listed without an FDA application

This product's marketing category indicates it is marketed without an approved FDA application (no NDA, ANDA, or BLA on file). Having an NDC does not by itself establish FDA approval — the NDC Directory is a listing system, not an approval decision. Approval-linked data such as Orange Book therapeutic-equivalence ratings therefore does not apply.

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) ✓ Available
“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 "Unapproved Drug Other". Products approved under an application carry an NDA, ANDA, or BLA number.
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 APNAR PHARMA LP. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
APNAR PHARMA LP 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.
← 24689-0101-01 · APNAR 24689-0103-01 · APNAR →
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.