Home › NDC Lookup › Ingredients › Oxytocin › 00641-6114-25
Oxytocin 10 [USP'U]/mL Injection, 25 vials — NDC 00641-6114-25 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Oxytocin 10 [USP'U]/mL Injection, 25 vials — NDC 0641-6114-25 (Billing 00641-6114-25)

by Hikma Pharmaceuticals USA Inc. · 25 VIAL in 1 CARTON / 1 mL in 1 VIAL

This is a package of 25 vials of Oxytocin 10 [USP'U]/mL Injection from Hikma Pharmaceuticals USA Inc., no longer marketed, no longer in the FDA NDC Directory. It is this product's only package size.

NDC 00641-6114-25
🏷️ FDA NDC (as labeled) 0641-6114-25 billing pads the labeler segment with a zero
Rx only Brand Discontinued Non-controlled ⚠ Inactivated by FDA ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 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 →

This page is curated, coded, and maintained by

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

⚠️
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 2024. 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) 0641-6114-25
Product NDC 0641-6114
11-digit billing NDC 00641611425
NCPDP billing unit ML — per mL (volume)
Application # NDA018243
SPL Set ID a9b62187-4141-487c-a9da-f42ad7f9b408
Chemical class Increased Uterine Smooth Muscle Contraction or Tone [PE], Oxytocic [EPC], Oxytocin
DEA schedule Non-controlled
Marketing category NDA
Marketing status Discontinued
FDA listing status Inactivated by FDA (certified through Dec 2024)
Route INTRAMUSCULAR; INTRAVENOUS
Dosage form INJECTION
Substance OXYTOCIN
TE code (Orange Book) AP · RLD · RS

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

GCN Seq No 003283
GCN 11400
HICL code 001447
Ingredient (HICL) Oxytocin
HIC1 code G
Therapeutic class — broad (HIC1) Female Genital System
HIC2 code G3
Therapeutic class — intermediate (HIC2) Oxytocics
HIC3 code G3A
Therapeutic class — specific (HIC3) Oxytocics
AHFS code 76:00.00.00
AHFS class Oxytocics
FDB label name OXYTOCIN 10 UNIT/ML VIAL
FDB brand name Oxytocin
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 003283
  • GCN: 11400
  • HICL (First Databank): 001447
  • AHFS class code: 76:00.00.00
Why two NDCs? The FDA registers this code as 0641-6114-25 — a 4-4-2 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 labeler segment → 00641-6114-25. 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 OXYTOCIN 10 UNIT/ML VIAL Ingredient Oxytocin

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.
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
00641-6114-25 You're viewing this Main listing 25 VIAL in 1 CARTON / 1 mL in 1 VIAL 1980-04-29 — Inactivated by FDA

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Oxytocin 10 [USP'U]/mLthis 00641-6114-25 Hikma 25 vials — AP Discontinued —
About this product: this is the brand-name version. Some generic versions are approved by the FDA, but we could not confirm current pharmacy availability from our pricing/market data.
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 approved (availability unconfirmed)
see note
🔒Generic approved by FDA, but pharmacy availability is not confirmed

The FDA lists approved generic versions of this medicine, but that does not always mean a pharmacy can get one today. Patent rules, launch agreements, supply and pricing can affect when generics actually arrive.

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

LabelerHikma Pharmaceuticals USA Inc.
Application holderHIKMA PHARMACEUTICALS USA INC
FDA applicationNDA018243 (NDA)
Labeler code00641
Product typeHuman Prescription Drug
Portfolio726 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.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug Interactions 🤰 Pregnancy 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description ⚠️ Precautions 🍼 Nursing Mothers 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🚨 Boxed Warning 62 words ▾

IMPORTANT NOTICE Oxytocin is indicated for the medical rather than the elective induction of labor. Available data and information are inadequate to define the benefits-to-risks considerations in the use of the drug product for elective induction. Elective induction of labor is defined as the initiation of labor for convenience in an individual with a term pregnancy who is free of medical indications.

🎯 Indications and Usage ~1 min read ▾

INDICATIONS AND USAGE IMPORTANT NOTICE Oxytocin is indicated for the medical rather than the elective induction of labor. Available data and information are inadequate to define the benefits-to-risks considerations in the use of the drug product for elective induction. Elective induction of labor is defined as the initiation of labor for convenience in an individual with a term pregnancy who is free of medical indications.

Antepartum Oxytocin is indicated for the initiation or improvement of uterine contractions, where this is desirable and considered suitable for reasons of fetal or maternal concern, in order to achieve early vaginal delivery. It is indicated for (1) induction of labor in patients with a medical indication for the initiation of labor, such as Rh problems, maternal diabetes, preeclampsia at or near term, when delivery is in the best interests of mother and fetus or when membranes are prematurely ruptured and delivery is indicated; (2) stimulation or reinforcement of labor, as in selected cases of uterine inertia; (3) as adjunctive therapy in the management of incomplete or inevitable abortion.

In the first trimester, curettage is generally considered primary therapy. In second trimester abortion, oxytocin infusion will often be successful in emptying the uterus. Other means of therapy, however, may be required in such cases.

Postpartum Oxytocin is indicated to produce uterine contractions during the third stage of labor and to control postpartum bleeding or hemorrhage.

⏱️ Dosage and Administration ~2 min read ▾

DOSAGE AND ADMINISTRATION Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Dosage of oxytocin is determined by the uterine response. The following dosage information is based upon various regimens and indications in general use.

A. Induction or Stimulation of Labor Intravenous infusion (drip method) is the only acceptable method of administration for the induction or stimulation of labor. Accurate control of the rate of infusion flow is essential.

An infusion pump or other such device and frequent monitoring of strength of contractions and fetal heart rate are necessary for the safe administration of oxytocin for the induction or stimulation of labor. If uterine contractions become too powerful, the infusion can be abruptly stopped, and oxytocic stimulation of the uterine musculature will soon wane. An intravenous infusion of nonoxytocin-containing solution should be started.

Physiologic electrolyte solution should be used except under unusual circumstances. To prepare the usual solution for infusion, 1-mL Oxytocin Injection, 10 USP Units/mL is combined aseptically with 1,000 mL of nonhydrating diluent (physiologic electrolyte solution). The combined solution, rotated in the infusion bottle to ensure thorough mixing, containing 10 mU/mL.

Add the container with dilute oxytocic solution to the system through use of a constant infusion pump or other such device, to control accurately the rate of infusion. The initial dose should be no more than 1 to 2 mU/min. the dose may be gradually increased in increments of no more than 1 to 2 mU/min. until a contraction pattern has been established which is similar to normal labor. The fetal heart rate, resting uterine tone, and the frequency, duration, and the force of contractions should be monitored.

The oxytocin infusion should be discontinued immediately in the event of uterine hyperactivity or fetal distress. Oxygen should be administered to the mother. The mother and the fetus must be evaluated by the responsible physician.

B. Control of Postpartum Uterine Bleeding Intravenous Infusion (Drip Method): To control postpartum bleeding, 10 to 40 units of oxytocin may be added to 1,000 mL of a nonhydrating diluent (physiologic electrolyte solution) and run a rate necessary to control uterine atony. Intramuscular Administration: 1 mL (10 units) of oxytocin can be given after the delivery of the placenta.

C. Treatment of Incomplete or Inevitable Abortion Intravenous infusion with physiologic saline solution, 500 mL, or 5% dextrose in physiologic saline solution to which 10 units of oxytocin have been added should be infused at a rate of 20 to 40 drops per minutes.

⛔ Contraindications 98 words ▾

CONTRAINDICATIONS Oxytocin is contraindicated in any of the following conditions: significant cephalopelvic disproportion; unfavorable fetal positions or presentations which are undeliverable without conversion prior to delivery, e.g., transverse lies; in obstetrical emergencies where the benefit-to-risk ratio for either the fetus or the mother favors surgical intervention; in cases of fetal distress where delivery is not imminent; hypertonic uterine patterns; hypersensitivity to the drug. Prolonged use in uterine inertia or severe toxemia is contraindicated.

Oxytocin should not be used in cases where vaginal delivery is not indicated, such as cord presentation or prolapse, total placenta previa, and vasa previa.

⚠️ Warnings 27 words ▾

WARNINGS Oxytocin, when given for induction or stimulation of labor, must be administered only by intravenous infusion (drip method) and with adequate medical supervision in a hospital.

🤒 Adverse Reactions 143 words ▾

ADVERSE REACTIONS The following adverse reactions have been reported in the mother: Anaphylactic reaction Nausea Postpartum hemorrhage Vomiting Cardiac arrhythmia Premature ventricular contractions Fatal afibrinogenemia Pelvic hematoma Excessive dosage or hypersensitivity to the drug may result in uterine hypertonicity, spasm, tetanic contraction, or rupture of the uterus. The possibility of increased blood loss and afibrinogenemia should be kept in mind when administering the drug. Severe water intoxication with convulsions and coma has occurred, associated with a slow oxytocin infusion over a 24-hour period.

Maternal death due to oxytocin-induced water intoxication has been reported. The following adverse reactions have been reported in the fetus or infant: (Due to induced uterine motility) Bradycardia Premature ventricular contractions and other arrhythmias Permanent CNS or brain damage Fetal death (Due to use of oxytocin in the mother) Low Apgar scores at five minutes Neonatal jaundice Neonatal retinal hemorrhage

🔄 Drug Interactions 61 words ▾

Drug Interactions Severe hypertension has been reported when oxytocin was given three to four hours following prophylactic administration of a vasoconstrictor in conjunction with caudal-block anesthesia. Cyclopropane anesthesia may modify oxytocin’s cardiovascular effects, so as to produce unexpected results such as hypotension. Maternal sinus bradycardia with abnormal atrioventricular rhythms has also been noted when oxytocin was used concomitantly with cyclopropane anesthesia.

🤰 Pregnancy 73 words ▾

Pregnancy PREGNANCY CATEGORY C. There are no known indications for use of oxytocin in the first and second trimester of pregnancy other than in relation to spontaneous or induced abortion. Based on the wide experience with this drug and its chemical structure and pharmacological properties, it would not be expected to present a risk of fetal abnormalities when used as indicated. NONTERATOGENIC EFFECTS See “ ADVERSE REACTIONS ” in the fetus or infant.

🆘 Overdosage 113 words ▾

OVERDOSAGE Overdosage with oxytocin depends essentially on uterine hyperactivity whether or not due to hypersensitivity to this agent. Hyperstimulation with strong (hypertonic) or prolonged (tetanic) contractions, or a resting tone of 15 to 20 mm H 2 O or more between contractions can lead to tumultuous labor, uterine rupture, cervical and vaginal lacerations, postpartum hemorrhage, utero-placental hypoperfusion, and variable deceleration of fetal heart, fetal hypoxia, hypercapnia, or death. Water intoxication with convulsions, which is caused by the inherent antidiuretic effect of oxytocin, is a serious complication that may occur if large doses (40 to 50 milliunits/minute) are infused for long periods.

Management consists of immediate discontinuation of oxytocin and symptomatic and supportive therapy.

🧬 Clinical Pharmacology 191 words ▾

CLINICAL PHARMACOLOGY The pharmacologic and clinical properties of oxytocin are identical with those of naturally occurring oxytocin principle of the posterior lobe of pituitary. Oxytocin exerts a selective action on the smooth musculature of the uterus, particularly toward the end of pregnancy, during labor, and immediately following delivery. Oxytocin stimulates rhythmic contractions of the uterus, increases the frequency of existing contractions, and raises the tone of the uterine musculature.

When given in appropriate doses during pregnancy, oxytocin is capable of eliciting graded increases in uterine motility from a moderate increase in the rate and force of spontaneous motor activity to sustained titanic contraction. The sensitivity of the uterus to oxytocic activity increases progressively throughout pregnancy until term when it is maximal. Oxytocin is distributed throughout the extracellular fluid.

Small amounts of this drug probably reach the fetal circulation. Oxytocin has a plasma half-life of about 3 to 5 minutes. Following parenteral administration, uterine response occurs within 3 to 5 minutes and persists for 2 to 3 hours.

Its rapid removal from plasma is accomplished largely by the kidney and the liver. Only small amounts oxytocin are excreted in the urine unchanged.

📦 How Supplied / Storage and Handling 101 words ▾

HOW SUPPLIED Oxytocin Injection, USP (synthetic), 10 USP units per mL is packaged in single or multiple dose vial and supplied as follows: NDC Vial Size Fill Volume Usage Package size 0641-6114-25 2 mL 1 mL Single Dose Vial 25 0641-6115-25 10 mL 10 mL Multiple Dose Vial 25 Store at 25°C (77°F); excursions permitted to 15–30°C (59-86°F) [See USP Controlled Room Temperature]. Do not freeze. Do not use if solution is discolored or contains a precipitate.

To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceutcial Corp. at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . For Product Inquiry call 1-877-845-0689.

📋 Description 68 words ▾

DESCRIPTION Each mL of Oxytocin Injection sterile solution contains an oxytocic activity equivalent to 10 USP Posterior Pituitary Units, Chlorobutanol (a chloroform derivative), 0.5%, as a preservative, and acetic acid to adjust pH (3.0 to 5.0). Oxytocin is intended for IM or IV use. Oxytocin is a synthetic polypeptide; it occurs as a white powder and is soluble in water. It may be designated chemically as: Structural formula

⚠️ Precautions ~2 min read ▾

PRECAUTIONS General All patients receiving intravenous infusions of oxytocin must be under continuous observation by trained personnel with a thorough knowledge of the drug and are qualified to identify complications. A physician qualified to manage any complications should be immediately available. When properly administered, oxytocin should stimulate uterine contractions similar to those seen in normal labor.

Overstimulation of the uterus by improper administration can be hazardous to both mother and fetus. Even with proper administration and adequate supervision, hypertonic contractions can occur in patients whose uteri are hypersensitive to oxytocin. Except in unusual circumstances, oxytocin should not be administered in the following conditions: prematurity, borderline cephalopelvic disproportion, previous major surgery on the cervix or uterus, including cesarean section, overdistention of the uterus, grand multiparity, or invasive cervical carcinoma.

Because of the variability of the combinations of factors which may be present in the conditions listed above, the definition of “unusual circumstances” must be left to the judgment of the physician. The decision can only be made by carefully weighing the potential benefits which oxytocin can provide in a given case against the rare occurrence of hypertonicity or tetanic spasm with this drug. Maternal deaths due to hypertensive episodes, subarachnoid hemorrhage, rupture of the uterus, and fetal deaths and permanent CNS or brain damage of the infant due to various causes have been reported to be associated with the use of parenteral oxytocic drugs for induction of labor or for augmentation in the first and second stages of labor.

Oxytocin has been shown to have an intrinsic antidiuretic effect, acting to increase water reabsorption from the glomerular filtrate. Consideration should, therefore, be given to the possibility of water intoxication, particularly when oxytocin is administered continuously by infusion and the patient is receiving fluids by mouth. Oxytocin should be considered for use only in patients who have been carefully selected.

Pelvic adequacy must be considered and maternal and fetal conditions thoroughly evaluated before use of the drug. Drug Interactions Severe hypertension has been reported when oxytocin was given three to four hours following prophylactic administration of a vasoconstrictor in conjunction with caudal-block anesthesia. Cyclopropane anesthesia may modify oxytocin’s cardiovascular effects, so as to produce unexpected results such as hypotension.

Maternal sinus bradycardia with abnormal atrioventricular rhythms has also been noted when oxytocin was used concomitantly with cyclopropane anesthesia. Carcinogenesis, Mutagenesis, Impairment of Fertility There are no animal or human studies on the carcinogenicity and mutagenicity of this drug, nor is there any information on its effect on fertility. Pregnancy PREGNANCY CATEGORY C.

There are no known indications for use of oxytocin in the first and second trimester of pregnancy other than in relation to spontaneous or induced abortion. Based on the wide experience with this drug and its chemical structure and pharmacological properties, it would not be expected to present a risk of fetal abnormalities when used as indicated. NONTERATOGENIC EFFECTS See “ ADVERSE REACTIONS ” in the fetus or infant.

Labor and Delivery See “ INDICATIONS AND USAGE ” 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 oxytocin is administered to a nursing woman.

🍼 Nursing Mothers 34 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 oxytocin is administered to a nursing woman.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 30 words ▾

Carcinogenesis, Mutagenesis, Impairment of Fertility There are no animal or human studies on the carcinogenicity and mutagenicity of this drug, nor is there any information on its effect on fertility.

📄 Package Label / Principal Display Panel 86 words ▾

PRINCIPAL DISPLAY PANEL NDC 0641-6114-01 Oxytocin Injection, USP (synthetic) 10 USP Units/mL For IV Infusion or IM Use 1 mL Single Dose Vial NDC 0641-6114-01 Oxytocin Injection, USP (synthetic) 10 USP Units/mL For IV Infusion or IM Use 1 mL Single Dose Vial

PRINCIPAL DISPLAY PANEL NDC 0641-6115-01 Oxytocin Injection, USP (synthetic) 10 USP Units/mL For IV Infusion or IM Use 10 mL Multiple Dose Vial NDC 0641-6115-01 Oxytocin Injection, USP (synthetic) 10 USP Units/mL For IV Infusion or IM Use 10 mL Multiple Dose Vial

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 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) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
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?
Hikma Pharmaceuticals USA Inc. 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.
← 00641-6103-25 · Hikma 00641-6116-10 · Hikma →
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.