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Hydroxyprogesterone Caproate 1250 mg/5mL Injection — NDC 55150-0311-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Hydroxyprogesterone Caproate 1250 mg/5mL Injection — NDC 55150-311-01 (Billing 55150-0311-01)

by Eugia US LLC · 1 VIAL in 1 CARTON / 5 mL in 1 VIAL

This is a package of Hydroxyprogesterone Caproate 1250 mg/5mL Injection from Eugia US LLC, marketed since May 2019 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 55150-0311-01
🏷️ FDA NDC (as labeled) 55150-311-01 billing pads the product segment with a zero
This package
Contains5 mL in 1 vial Pack sizes2 compare ↓
Main listing for product 55150-311 · Also comes in: 5 vials 55150-311-05
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 55150-311-01 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
55150 labeler · 311 product · 01 package
Package marketed since
May 9, 2019
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 5515031101 9
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 55150-311-01
Product NDC 55150-311
11-digit billing NDC 55150031101
RxCUI 1087964
UNII 276F2O42F5
Application # ANDA211142
SPL Set ID 687bcf42-f437-42c7-8909-a91f621f55df
Established class (EPC) Progestin
Chemical class Progesterone Congeners
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2019-05-09
Route INTRAMUSCULAR
Dosage form INJECTION
Substance HYDROXYPROGESTERONE CAPROATE
Quick answers
  • RxCUI (RxNorm): 1087964
Why two NDCs? The FDA registers this code as 55150-311-01 — 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 → 55150-0311-01. 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 Progestin class.

Pharmacologic class Progestin
Drug family (ATC) Pregnen (4) derivatives
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

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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.
Try another pack size: 5 vials
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
55150-0311-01 You're viewing this Main listing 1 VIAL in 1 CARTON / 5 mL in 1 VIAL 2019-05-09 — Active
55150-0311-05 55150-311-05 5 VIAL in 1 CARTON / 5 mL in 1 VIAL 2019-05-09 — Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 1 vial in 1 carton / 5 ml in 1 vial.
What NDC number is used to bill for this package of Hydroxyprogesterone Caproate 1250 mg/5mL Injection?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Hydroxyprogesterone Caproate 1250 mg/5mLthis 55150-0311-01 Eugia 1 vial — — 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

🏛️
2019
On the market since
May 2019
📍
2026
Currently FDA-listed
7 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.

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

LabelerEugia US LLC
Application holderEUGIA PHARMA SPECIALITIES LTD
FDA applicationANDA211142 (ANDA)
Labeler code55150
First marketedMay 2019
Product typeHuman Prescription Drug
Portfolio241 products on file

More NDCs from Eugia US LLC labeler code 55150

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 ⚠️ Warnings 🤒 Adverse Reactions 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients ⚠️ Precautions 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 71 words ▾

INDICATIONS AND USAGE Hydroxyprogesterone Caproate Injection, USP is indicated in non-pregnant women: for the treatment of advanced adenocarcinoma of the uterine corpus (Stage III or IV); in the management of amenorrhea (primary and secondary) and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as submucous fibroids or uterine cancer; as a test for endogenous estrogen production and for the production of secretory endometrium and desquamation.

⏱️ Dosage and Administration ~3 min read ▾

DOSAGE AND ADMINISTRATION Suggested dosages are presented in the therapy guide. Because of the low viscosity of the vehicle, Hydroxyprogesterone Caproate Injection, USP may be administered with a small gauge needle. Care should be taken to inject the preparation deeply into the upper outer quadrant of the gluteal muscle following the usual precautions for intramuscular injection.

Since the 250 mg potency provides a high concentration in a small volume, particular care should be observed to administer the full dose. Note: Use of a wet needle or syringe may cause the solution to become cloudy; however, this does not affect the potency of the material. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Protect from light. Store vial in its box. Store upright.

Discard any unused product within 5 weeks after first use. THERAPY GUIDE CYCLIC THERAPY SCHEDULE: (28-day cycle; repeated every 4 weeks); Day 1 of each cycle: 20 mg Estradiol Valerate Injection, USP 2 weeks after Day 1: 250 mg Hydroxyprogesterone Caproate Injection, USP and 5 mg Estradiol Valerate Injection, USP 4 weeks after Day 1. This is Day 1 of next cycle SUGGESTED CYCLIC REGIMEN Indications Dosage Started Repeated Stopped Comments Amenorrhea (primary and secondary): Abnormal uterine bleeding due to hormonal imbalance in the absence of organicpathology, such as submucous fibroids or uterine cancer.

375 mg Any time - - Genital malignancy should be excluded before hormone therapy is started. Hydroxyprogesterone caproate is used as a “Medical D and C” to eliminate any proliferated endometrium from previous estrogenic action by conversion to secretory endometrium and desquamation. To determine onset of normal cyclic functions, patient should be observed for 2 or 3 cycles after cessation of therapy.

Cyclic Therapy Schedule After 4 days of desquamation or, if there is no bleeding, 21 days after Hydroxyprogesterone Caproate Injection, USP alone Every 4 weeks After 4 cycles Production of secretory endometrium and desquamation Patients not on estrogen therapy: Cyclic Therapy Schedule Any time Every 4 weeks When cyclic therapy is no longer required If estrogen deficiency has been prolonged, menstruation may not occur until estrogen has been given for several months. Patients currently on estrogen therapy: 375 mg Hydroxy progesterone Caproate Injection, USP Any time - - Cyclic Therapy Schedule After 4 days of desquamation or, if there is no bleeding, 21 days after Hydroxyprogesterone Caproate Injection, USP alone Every 4 weeks When cyclic therapy is no longer required SUGGESTED NON-CYCLIC REGIMEN Indications Dosage Started Repeated Stopped Comments Adenocarcinoma of uterine corpus in advanced stage (Stage III or IV) 1,000 mg or more At once 1 or more times each week (1 to 7 g per week) When relapse occurs, or after 12 weeks with no objective response Should not be used in early stage (Stage I or II) in place of established anticancer therapy.

May be used in advanced stage concomitantly with other anticancer therapy (surgery, α radiation, or chemotherapy, or combination of these). Treatment results reported to date have been better in histologically well-differentiated forms of endometrial adenocarcinoma. (The drug has not been adequately studied in non-endometrioid adenocarcinoma of the uterine corpus).

Test for endogenous estrogen production ("Medical D and C") 250 mg Any time For confirmation, 4 weeks after 1 st injection After 2 nd injection Non-pregnant patient with responsive endometrium; bleeding 7 to14 days after injection indicates endogenous estrogen.

⛔ Contraindications 67 words ▾

CONTRAINDICATIONS Hydroxyprogesterone caproate is contraindicated in patients with known or suspected carcinoma of the breast, other hormone-sensitive cancer, or history of these conditions; undiagnosed abnormal vaginal bleeding; liver dysfunction or disease; missed abortion, and in those with a history of hypersensitivity to the drug. Hydroxyprogesterone caproate is also contraindicated as a diagnostic test for pregnancy and in patients with current or history of thrombotic or thromboembolic disorders.

⚠️ Warnings 86 words ▾

WARNINGS Thrombotic and Thromboembolic Events Discontinue the medication pending examination if there is a sudden partial or complete loss of vision or if there is a sudden onset of proptosis, diplopia, or migraine. Medication should be stopped if examination reveals papilledema or retinal vascular lesions. Allergic reactions Hypersensitivity reaction to progestins have been reported.

Hydroxyprogesterone caproate is contraindicated in women with a history of hypersensitivity to a progestin. Glucose tolerance Progestins may decrease glucose tolerance and the blood glucose concentration should be monitored in diabetic users.

🤒 Adverse Reactions 197 words ▾

ADVERSE REACTIONS A. Serious arterial thrombotic and venous thromboembolic events, including cases of pulmonary emboli (some fatal), deep vein thrombosis, myocardial infarction, and strokes, have been reported in women using progestins. B. neuroocular lesions (e.g., retinal thrombosis and optic neuritis); nausea; vomiting; gastrointestinal symptoms (such as abdominal cramps or bloating); edema; breakthrough bleeding, spotting, or withdrawal bleeding; breast tenderness; changes in body weight (increase or decrease); headache; increase in cervical mucus; allergic rash; abscess; pain at the injection site; migraine headaches.

C. chloasma or melasma, cholestatic jaundice, rise in blood pressure, mental depression, and amenorrhea during or after treatment. D. posttreatment anovulation, cystitis, hirsutism, loss of scalp hair, changes in libido, changes in appetite, dizziness, fatigue, backache, itching, or amenorrhea. E.

The following laboratory tests may be affected by progestins: hepatic function (increased sulfobromophthalein retention and other tests); coagulation tests (increased in prothrombin and Factors VII, VIII, IX, and X); thyroid function tests (increase in PBI and butanol extractable protein-bound iodine, decrease in T3 uptake values. A few instances of coughing, dyspnea, constriction of the chest, and/or allergic-like reactions have occurred following hydroxyprogesterone caproate therapy; the likelihood of these occurring may be increased at higher dosage levels.

🧬 Clinical Pharmacology ~1 min read ▾

CLINICAL PHARMACOLOGY Hydroxyprogesterone is a potent, long-acting, progestational steroid ester which transforms proliferative endothelium into secretory endothelium, induces mammary gland duct development, and inhibits the production and/or release of gonadotropic hormone; it also shows slight estrogenic, androgenic, or corticoid effects as well, but should not be relied upon for these effects. In advanced adenocarcinoma of the uterine corpus, Hydroxyprogesterone Caproate Injection, USP in a dosage of 1,000 mg or more, one or more times each week, often induces regressive changes.

Absorption : Peak serum levels of hydroxyprogesterone caproate appeared after 3 to 7 days in non-pregnant female subjects following a single intramuscular injection of 1,000 mg hydroxyprogesterone caproate. The pharmacokinetics of the 250 mg dose of hydroxyprogesterone caproate has not been evaluated in a study. Metabolism : The conjugated metabolites include sulfated and glucuronidated products.

In vitro data indicate that the metabolism of hydroxyprogesterone caproate is predominantly mediated by CYP3A4 and CYP3A5. Excretion : Both conjugated metabolites and free steroids are excreted in the urine and feces, with the conjugated metabolites being prominent. Hepatic Impairment The effect of hepatic impairment on the pharmacokinetics of hydroxyprogesterone caproate has not been evaluated.

Hydroxyprogesterone caproate is extensively metabolized and hepatic impairment may reduce the elimination of hydroxyprogesterone caproate. Renal Impairment The effect of renal impairment on the pharmacokinetics of hydroxyprogesterone caproate has not been evaluated.

📦 How Supplied / Storage and Handling 175 words ▾

HOW SUPPLIED Hydroxyprogesterone Caproate Injection, USP is available in vials providing hydroxyprogesterone caproate with a potency of 250 mg per mL. The product is formulated in castor oil and 46% benzyl benzoate and containing 2% (v/v) benzyl alcohol as a preservative. Hydroxyprogesterone Caproate Injection, USP is a sterile, clear pale yellow to yellow color oily solution and is supplied as follows: 5 mL Multiple-Dose Vial Packaged Individually NDC 55150-311-01 5 mL Multiple-Dose Vials in a carton of 5 NDC 55150-311-05 Storage Hydroxyprogesterone Caproate Injection, USP should be stored at controlled room temperature 20° to 25° C (68° to 77° F).

Storage at low temperatures may result in the separation of some crystalline material which redissolves readily on heating in boiling water. Protect from light. Store vial in its box.

Store upright. Discard any unused product within 5 weeks after first use. The vial stopper is not made with natural rubber latex.

Distributed by: AuroMedics Pharma LLC 279 Princeton-Hightstown Road E.Windsor, NJ 08520 Manufactured by: Eugia Pharma Specialities Limited Hyderabad – 500032 India Revised: June 2022

📋 Description 99 words ▾

DESCRIPTION Hydroxyprogesterone Caproate Injection, USP is a sterile, long-acting preparation of the caproate ester of the naturally- occurring progestational hormone, hydroxyprogesterone, in an oil solution for intramuscular use. The chemical name for hydroxyprogesterone caproate is pregn-4-ene-3,20-dione, 17[(1-oxohexyl)oxy]. It has a molecular formula of C 27 H 40 O 4 and a molecular weight of 428.60.

Hydroxyprogesterone caproate exists as white or creamy white crystalline powder. The structural formula is: Each 5 mL multiple-dose vial contains hydroxyprogesterone caproate, 250 mg/mL, in castor oil (28.6% v/v) and benzyl benzoate (46 % v/v) with the preservative benzyl alcohol (2% v/v). Chemical Structure

💬 Information for Patients 44 words ▾

Information for The Patient Counsel patients that hydroxyprogesterone caproate injections may cause pain, soreness, swelling, itching or bruising. Inform the patient to contact her physician if she notices increased discomfort over time, oozing of blood or fluid, or inflammatory reactions at the injection site.

⚠️ Precautions 211 words ▾

PRECAUTIONS Detectable amounts of progestins have been identified in the milk of mothers receiving the drug. Many studies have found no adverse effects of progestins on breastfeeding performance, or on the health, growth, or development of the infant. Because progestational drugs may cause some degree of fluid retention, conditions that might be influenced by this effect, such as asthma, migraine, epilepsy, or cardiac or renal dysfunction require careful observation.

The pretreatment physical examination should include examination of the breasts and pelvic organs and a Papanicolaou smear. In relation to irregular bleeding which does not respond predictably to the hormone therapy, nonfunctional causes should be borne in mind and adequate diagnostic measures instituted. Any influence of prolonged sex hormone medication on pituitary, ovarian, adrenal, hepatic, or uterine function awaits further study.

The pathologist should be advised of progesterone therapy when relevant specimens are submitted. Patients who have a history of psychic depression should be carefully observed and the drug discontinued if the depression recurs to a serious degree. Information for The Patient Counsel patients that hydroxyprogesterone caproate injections may cause pain, soreness, swelling, itching or bruising.

Inform the patient to contact her physician if she notices increased discomfort over time, oozing of blood or fluid, or inflammatory reactions at the injection site.

📄 Package Label / Principal Display Panel 189 words ▾

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1,250 mg per 5 mL (250 mg / mL) - Container Label Rx only NDC 55150-311-01 Hydroxyprogesterone Caproate Injection, USP 1,250 mg per 5 mL (250 mg / mL) For Intramuscular Use Only 5 mL Multiple Dose Vial AUROMEDICS PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1,250 mg per 5 mL (250 mg / mL) - Container Label

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1,250 mg per 5 mL (250 mg / mL) – Container-Carton (1 vial) Rx only NDC 55150-311-01 Hydroxyprogesterone Caproate Injection, USP 1,250 mg per 5 mL (250 mg / mL) For Intramuscular Use Only 5 mL Multiple Dose Vial AUROMEDICS PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1,250 mg per 5 mL (250 mg / mL) – Container-Carton (1 vial)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1,250 mg per 5 mL (250 mg / mL) – Container-Carton (5 vials) Rx only NDC 55150-311-05 Hydroxyprogesterone Caproate Injection, USP 1,250 mg per 5 mL (250 mg / mL) For Intramuscular Use Only 5 x 5 mL Multiple Dose Vials AUROMEDICS PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1,250 mg per 5 mL (250 mg / mL) – Container-Carton (5 vials)

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

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) — 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

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 Eugia US LLC. 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 1 other package presentation of this same product, including 5 vials (55150-0311-05). 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?
Eugia US 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.
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.
← 55150-0308-01 · Eugia 55150-0313-01 · Eugia →
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.