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PROGESTERONE 50 mg/mL Injection, Solution, 10 mL — NDC 0591-3128-79 (Billing 00591-3128-79)

by Actavis Pharma, Inc. · 10 mL in 1 VIAL, MULTI-DOSE

This is a package of 10 mL of PROGESTERONE 50 mg/mL Injection, Solution from Actavis Pharma, Inc., no longer marketed (first marketed May 1978), no longer in the FDA NDC Directory; retail pharmacies pay about $1.36 per mL (NADAC). It is this product's only package size.

NDC 00591-3128-79
🏷️ FDA NDC (as labeled) 0591-3128-79 billing pads the labeler segment with a zero
Rx only Brand Discontinued Non-controlled ⚠ Discontinued by firm ⇄ 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 0591-3128-79 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
0591 labeler · 3128 product · 79 package
Package marketed since
May 11, 1978
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Billing quantity
10 mL per package
Barcode (UPC-A, from the NDC)
3 0591312879 8
Medicaid fills, this package
43 prescriptions in the last four reported quarters
FDA record last changed
Jul 24, 2026
⚠️
Other active recalls for Progesterone (different manufacturers) — 2 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Dec 27, 2024 — Presence of Particulate Matter: A market complaint was received of a glass piece in the vial. (Eugia US LLC) · FDA recall D-0186-2025
Class II · Jul 26, 2024 — Presence of Particulate Matter: Complaint received of a glass particle in the vial. (Eugia US LLC) · FDA recall D-0624-2024
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗
⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through Feb 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) 0591-3128-79
Product NDC 0591-3128
11-digit billing NDC 00591312879
NCPDP billing unit ML — per mL (volume)
RxCUI 312644
UNII 4G7DS2Q64Y
Application # NDA017362
SPL Set ID a09a3b76-36f1-4d20-930e-7e3da97e7ebd
Established class (EPC) Progesterone
Chemical class Progesterone
DEA schedule Non-controlled
Marketing category NDA
Marketing status Discontinued
FDA listing status Discontinued by firm (certified through Feb 2023)
Marketing start 1978-05-11
Route INTRAMUSCULAR
Dosage form INJECTION, SOLUTION
Substance PROGESTERONE

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

GPI-14 26000040001705
GPI class Progesterone
GCN Seq No 003262
GCN 11142
HICL code 001440
Ingredient (HICL) Progesterone
HIC1 code G
Therapeutic class — broad (HIC1) Female Genital System
HIC2 code G2
Therapeutic class — intermediate (HIC2) Progestogens
HIC3 code G2A
Therapeutic class — specific (HIC3) Progestational Agents
AHFS code 68:32.00.00
AHFS class Progestins
FDB label name PROGESTERONE 500 MG/10 ML VIAL
FDB brand name Progesterone
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 003262
  • GCN: 11142
  • GPI-14 (Medi-Span): 26000040001705
  • HICL (First Databank): 001440
  • AHFS class code: 68:32.00.00
  • RxCUI (RxNorm): 312644
Why two NDCs? The FDA registers this code as 0591-3128-79 — 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 → 00591-3128-79. 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 Progesterone class.

Pharmacologic class Progesterone
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

Label name PROGESTERONE 500 MG/10 ML VIAL Ingredient Progesterone
📗 Our plain-language guide HelloPharmacist
  • It depends on the product. Vaginal forms support pregnancy in fertility treatment. Capsules prevent overgrowth of the uterine lining in postmenopausal women taking estrogen, and tr...
  • Take them at bedtime, as your prescriber directs. If they're hard to swallow, use a full glass of water while standing. Food can increase how much your body absorbs.
  • With capsules taken alongside estrogen, headache, breast tenderness, joint pain, dizziness, and bloating were common. Vaginal discharge and nausea were reported too. Tell your doct...
  • Get help for chest pain, sudden weakness or trouble speaking, leg swelling, or sudden shortness of breath. These can be signs of a stroke, heart attack, or blood clot. Sudden visio...
📖 Read our full Progesterone 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 $1.361 $13.61 / 10 ml
Medicaid paysCMS SDUD · 12 mo $1.45 $14.52 / 10 ml
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
Medicare Part B allowsASP · J2675 $0.559 / J2675 unit —
NADAC price history (per mL) — tap or hover for the price & month
Dec 2021 Sep 2022 Feb 2026 Sep 2026 $2.666 $1.361
▼ Down 49% over the last 22 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.

Billing & reimbursement

FDA NDC (as labeled)0591-3128-79
11-digit billing NDC00591-3128-79
Format4-4-2 as registered → padded to 5-4-2 for billing (zero added to the labeler segment)
HCPCS J-codeJ2675
DescriptorINJECTION, PROGESTERONE, PER 50 MG
Billing units / pkg1 units
How the units are derivedThis package is 10 ML; the HCPCS unit is 50 MG, so one package = 1 billing unit.
Medicare Part B spend (2026 (Q1))$144 · 200 claims · $0.72 per claim (all NDCs under J2675)
Crosswalk sourcePDAC NDC-HCPCS crosswalk (DME MAC / DMEPOS)
Where does this data come from?
The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
00591-3128-79 You're viewing this Main listing 10 mL in 1 VIAL, MULTI-DOSE 1978-05-11 — Discontinued by firm

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Progesterone 50 mg 00143-9725-01 Hikma 10 injections $1.361 AO Availability likely —
Progesterone 50 mg/mLthis 00591-3128-79 Actavis 10 ml $1.361 — Discontinued —
Progesterone 50 mg/mL 55150-0306-10 Eugia 10 ml $1.361 AO Availability likely —
Progesterone 50 mg/mL 63323-0261-10 Fresenius 1 vial $1.361 AO Availability likely —
Progesterone 50 mg/mL 70700-0286-22 XIROMED, 10 ml $1.361 AO Availability likely —
About this product: this is the brand-name version. FDA-approved generic versions are listed, and recent pricing/market data suggests they may be 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

🏛️
1978
On the market since
May 1978
📍
2026
Currently FDA-listed
48 years listed
🔓
·
Generic versions listed
see equivalents
✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

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 Progesterone 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.

We could not link this NDC to a current FDA Structured Product Label. An inactive-ingredient list is therefore not available from this source.
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

LabelerActavis Pharma, Inc.
Application holderACTAVIS LABORATORIES UT INC
FDA applicationNDA017362 (NDA)
Labeler code00591
First marketedMay 1978
Product typeHuman Prescription Drug
Portfolio324 products on file

More NDCs from Actavis Pharma, Inc. labeler code 00591

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. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). 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 ⚠️ Precautions 📄 Patient Package Insert 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 30 words ▾

INDICATIONS AND USAGE This drug is indicated in amenorrhea and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as submucous fibroids or uterine cancer.

⏱️ Dosage and Administration 147 words ▾

DOSAGE AND ADMINISTRATION Progesterone is administered by intramuscular injection. It differs from other commonly used steroids in that it is irritating at the place of injection. Amenorrhea: Five to 10 mg are given for six to eight consecutive days.

If there has been sufficient ovarian activity to produce a proliferative endometrium, one can expect withdrawal bleeding forty-eight to seventy-two hours after the last injection. This may be followed by spontaneous normal cycles. Functional Uterine Bleeding: Five to 10 mg are given daily for six doses.

Bleeding may be expected to cease within six days. When estrogen is given as well, the administration of progesterone is begun after two weeks of estrogen therapy. If menstrual flow begins during the course of injections of progesterone, they are discontinued.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever the solution and container permit.

⛔ Contraindications 40 words ▾

CONTRAINDICATIONS Current or past history of thrombophlebitis, thromboembolic disorders, or cerebral apoplexy. Liver dysfunction or disease. Known or suspected malignancy of breast or genital organs. Undiagnosed vaginal bleeding. Missed abortion. Known sensitivity to progesterone injection. Known sensitivity to sesame oil/seeds.

⚠️ Warnings 173 words ▾

WARNINGS The physician should be alert to the earliest manifestations of thrombotic disorders (thrombophlebitis, cerebrovascular disorders, pulmonary embolism, and retinal thrombosis). Should any of these occur or be suspected, the drug should be discontinued immediately. Medication should be discontinued 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.

If examination reveals papilledema or retinal vascular lesions, medication should be withdrawn. Acute eosinophilic pneumonia has been reported in patients receiving progesterone in sesame oil. In reported cases associated with progesterone in sesame oil, patients developed fever, dyspnea with hypoxic respiratory insufficiency, and diffuse pulmonary infiltrates.

In general, patients developed eosinophilic pneumonia 2 to 4 weeks after starting progesterone in sesame oil and improved when progesterone in sesame oil was discontinued and a different formulation of progesterone and/or steroid therapy was initiated. Patients who develop these signs and symptoms while receiving progesterone in sesame oil should undergo prompt medical evaluation, and progesterone in sesame oil should be discontinued immediately.

🤒 Adverse Reactions ~1 min read ▾

ADVERSE REACTIONS Breakthrough bleeding; spotting; change in menstrual flow; amenorrhea; edema; change in weight (increase or decrease); changes in cervical erosion and cervical secretions; cholestatic jaundice; breast tenderness and galactorrhea; pain, irritation, and/or redness at the injection area; skin sensitivity reactions consisting of urticaria, pruritus, edema and generalized rash; acne, alopecia and hirsutism; rash (allergic) with and without pruritus; anaphylactoid reactions (including eosinophilic pneumonia); mental depression; pyrexia; insomnia; nausea; and somnolence.

A statistically significant association has been demonstrated between use of estrogen-progestin combination drugs and pulmonary embolism and cerebral thrombosis and embolism. For this reason patients on progestin therapy should be carefully observed. There is also evidence suggestive of an association with neuro-ocular lesions, e.g., retinal thrombosis and optic neuritis.

The following adverse reactions have been observed in patients receiving estrogen-progestin combination drugs: rise in blood pressure in susceptible individual, premenstrual syndrome, changes in libido, changes in appetite, cystitis-like syndrome, headache, nervousness, fatigue, backache, hirsutism, loss of scalp hair, erythema multiforme, erythema nodosum, hemorrhagic eruption, itching, and dizziness. The following laboratory results may be altered by the use of estrogen-progestin combination drugs: increased sulfobromophthalein retention and other hepatic function tests; coagulation tests: increase in prothrombin factors VII, VIII, IX, and X; metyrapone test; pregnanediol determinations; thyroid function: increase in PBI and butanol extractable protein bound iodine, and decrease in T 3 uptake values.

🧬 Clinical Pharmacology ~2 min read ▾

CLINICAL PHARMACOLOGY Transforms proliferative endometrium into secretory endometrium. Inhibits (at the usual dose range) the secretion of pituitary gonadotropins, which in turn prevents follicular maturation and ovulation. Pharmacokinetics and Metabolism: Absorption: After intramuscular administration of 10 mg of progesterone in oil, maximum plasma concentrations (geometric mean of 7 ng/mL) were reached within approximately 8 hours after injection and plasma concentrations remained above baseline for about 24 hours after injection.

Injection of 10, 25, and 50 mg resulted in geometric mean values for maximum plasma concentration (C MAX ) of 7, 28, and 50 ng/mL, respectively. Distribution: Progesterone is extensively bound to plasma proteins, primarily albumin (50-54%) and cortisol-binding protein (43-48%). Metabolism: Progesterone is metabolized primarily in the liver by reduction to pregnanediol, pregnanetriol, and pregnanolone.

Subsequent conjugation results in the formation of glucuronide and sulfate metabolites. The mean plasma metabolic clearance rate in cycling women is 2510 ± 135 (SEM) L/day. Excretion: The glucuronide and sulfate conjugates of pregnanediol and pregnanolone are excreted in the urine and bile.

Progesterone metabolites which are excreted in the bile may undergo enterohepatic recycling or may be excreted in the feces. The pharmacokinetic data was determined in a small number of patients, limiting the precision in which population values may be estimated. Special Populations: Renal Insufficiency: The safety and effectiveness in patients with renal insufficiency have not been established.

Since progesterone metabolites are excreted mainly by the kidneys, progesterone should be administered with caution and careful monitoring in this patient population (see PRECAUTIONS ). Hepatic Insufficiency: The safety and effectiveness in patients with hepatic insufficiency have not been established. Since progesterone is metabolized by the liver, use in patients with liver dysfunction or disease is contraindicated (see CONTRAINDICATIONS ).

Drug Interactions: The metabolism of progesterone by human liver microsomes was inhibited by ketoconazole (IC 50 < 01 μM). Ketoconazole is a known inhibitor of cytochrome P450 3A4 and these data suggest that ketoconazole or other known inhibitors of this enzyme may increase the bioavailability of progesterone. The clinical relevance of the in vitro findings is unknown.

📦 How Supplied / Storage and Handling 65 words ▾

HOW SUPPLIED Progesterone Injection USP, 500 mg/10 mL (50 mg/mL) is available in 10 mL multiple dose vials, individually boxed. (NDC 0591-3128-79) Store at 20°-25°C (68°-77°F). [See USP controlled room temperature.] Rx only For all medical inquiries contact: ACTAVIS Medical Communications Parsippany, NJ 07054 800-272-5525 Distributed By: Actavis Pharma, Inc. Parsippany, NJ 07054 USA Manufactured By: Hikma Farmacêutica Fervença 2705-906 Terrugem SNT Portugal Revised:August 2018

📋 Description 90 words ▾

DESCRIPTION Progesterone injection, a progestin, is a sterile solution of progesterone in a suitable vegetable oil available for intramuscular use. Progesterone occurs as a white or creamy white, crystalline powder. It is odorless and is stable in air.

Practically insoluble in water, it is soluble in alcohol, acetone, and dioxane and sparingly soluble in vegetable oils. It has the following structural formula: C 21 H 30 O 2 M.W. 314.47 Pregn-4-ene-3, 20-dione Each mL contains: Progesterone 50 mg, Benzyl Alcohol 10% as preservative in Sesame Oil q.s.

Progesterone structural formula.

⚠️ Precautions ~2 min read ▾

PRECAUTIONS General The pretreatment physical examination should include special reference to breast and pelvic organs, as well as a Papanicolaou smear. Because progestational drugs may cause some degree of fluid retention, conditions which might be influenced by this condition, such as epilepsy, migraine, asthma, cardiac, or renal dysfunction, require careful observation. In cases of breakthrough bleeding, as in all cases of irregular bleeding per vaginum, nonfunctional causes should be borne in mind, and adequate diagnostic measures undertaken.

Patients who have a history of psychic depression should be carefully observed and the drug discontinued if the depression recurs to a serious degree. The age of the patient constitutes no absolute limiting factor although treatment with progestin may mask the onset of the climacteric. The pathologist should be advised of progestin therapy when relevant specimens are submitted.

There are possible risks which may be associated with the use of progestin treatment, including adverse effects on carbohydrate and lipid metabolism. The dosage used may be important in minimizing these adverse effects. A decrease in glucose tolerance has been observed in a small percentage of patients on estrogen-progestin combination treatment.

The mechanism of this decrease is obscure. For this reason, diabetic patients should be carefully observed while receiving such therapy. Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term intramuscular administration of Medroxyprogesterone acetate (MPA) has been shown to produce mammary tumors in beagle dogs.

There is no evidence of a carcinogenic effect associated with the oral administration of MPA to rats and mice. Medroxyprogesterone acetate was not mutagenic in a battery of in vitro or in vivo genetic toxicity assays. Progesterone at high doses is an antifertility drug and high doses would be expected to impair fertility until the cessation of treatment.

Geriatric Use: The safety and effectiveness in geriatric patients (over age 65) have not been established. Pediatric Use: Safety and effectiveness in pediatric patients have not been established. Nursing Mothers: Detectable amounts of drug have been identified in the milk of mothers receiving progestational drugs.

The effect of this on the nursing infant has not been determined.

📄 Patient Package Insert ~3 min read ▾

PATIENT INFORMATION FOR THE TREATMENT OF AMENORRHEA (ABSENCE OF MENSES IN WOMEN WHO HAVE PREVIOUSLY HAD A MENSTRUAL PERIOD) OR ABNORMAL UTERINE BLEEDING DUE TO HORMONAL IMBALANCE. Please read this information carefully before you start to use Progesterone Injection and each time your prescription is renewed, in case anything has changed. This leaflet does not take the place of discussions with your doctor.

If you still have any questions, ask your doctor or health-care provider. About Progesterone Injection Progesterone Injection is a sterile injectable solution containing the natural female hormone called progesterone. Progesterone Injection is indicated for the treatment of amenorrhea and abnormal uterine bleeding due to progesterone deficiency.

Understanding the role of Progesterone Injection in the treatment of your menstrual irregularities. Progesterone is one of the hormones essential for regular menstrual periods. If your doctor has determined your body does not produce enough progesterone on its own, Progesterone Injection may be prescribed to provide the progesterone you need.

When you do not produce enough progesterone, menstrual irregularities can occur. Progesterone Injection can provide you with the progesterone needed during a normal menstrual cycle. Possible side effects of Progesterone Injection The following side effects have been reported with Progesterone Injection.

Consult your doctor if you experience any of the side effects mentioned below, or other side effects. anaphylactoid (life-threatening allergic) reaction with symptoms that may include a sense of uneasiness or apprehension; flushing; fast, throbbing heartbeat; itching; hives; difficult breathing; swelling of the throat; eosinophilic pneumonia (gathering of eosinophils, a type of white blood cell, in the lungs), fainting; nausea; vomiting; or convulsions. breakthrough bleeding spotting changes in menstrual flow amenorrhea change in weight (increase or decrease) pain, irritation, swelling, and/or redness at the injection area general swelling vaginal discharge yellow discoloration of skin or white of eyes breast tenderness, discharge from the nipple skin reactions including rash, hives, itching, and swelling acne hair loss or growth of new hair mental depression fever insomnia or sleepiness* nausea *If you experience sleepiness, do not drive or operate machinery.

When you should not use Progesterone Injection If you are allergic to progesterone, progesterone-like drugs, benzyl alcohol or sesame oil/seeds. If you have unusual vaginal bleeding which has not been evaluated by your doctor. If you have liver disease.

If you have known or suspected cancer of the breast or genital organs. If you have a miscarriage and your physician suspects some tissue is still in the uterus. If you have or have had blood clots in the legs, lungs, eyes, or elsewhere.

Risks of Progesterone Injection Abnormal blood clotting. Blood clots have been reported with the use of estrogens and progestational drugs (alone or in combination). If blood clots do form in your bloodstream, they can cut off the blood supply to vital organs, causing serious problems.

These problems may include a stroke (by cutting off blood to part of the brain), a heart attack (by cutting off blood to part of the heart), a pulmonary embolus (by cutting off blood to part of the lungs), or other problems. Any of these conditions may cause death or serious long-term disability. Call your doctor immediately if you suspect you have any of these conditions.

He or she may advise you to stop using this drug. Precautions Be alert for unusual signs and symptoms. If any of these warning signals (or any other unusual symptoms) happen while you are using Progesterone Injection, call your doctor immediately: Abnormal bleeding from the vagina.

Pains in the calves or chest, a sudden shortness of breath or coughing blood indicating possible clots in the legs, heart, or lungs. Severe headache or vomiting, dizziness, faintne… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 27 words ▾

PRINCIPAL DISPLAY PANEL Actavis Rx Only NDC 0591-3128-79 Progesterone Injection USP 500 mg/10 mL (50 mg/mL) For intramuscular use only Contains 10 mL Multiple Dose Vial 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
43
Units reimbursed last 4 qtrs
151
Gross reimbursed last 4 qtrs
$219.25
Avg / prescription
$5.10
Avg / unit
$1.4520
Latest quarter Q1 2026
0Rx
Medicaid pays / mL
$1.4520
gross reimbursed
vs
NADAC / mL
$1.3606
acquisition cost
=
Spread
+$0.0914
+7% vs cost
What Medicaid paid per mL (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 ⓘ
28% FFS 72% MCO
Fee-for-service · 12 Rx Managed care · 31 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: 120 units · 0.6 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: 18 units · 0.3 per 100k residents IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: no data reported 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: 13 units · 0.1 per 100k residents 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
0.10.6
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 0.6 /100k
2 Indiana 0.3 /100k
3 Georgia 0.1 /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 Progesterone — the program that covers self-administered drugs. 9 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 Progesterone. 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
$9.63M
Claims incl. refills
283.5K
Beneficiaries
217.7K
Spend / beneficiary
$44.23
Spend / claim
$33.97
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 — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) ✓ 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 ✓ Available
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

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?
Actavis Pharma, 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.
Does this product have a billing J-code?
Yes — this NDC cross-references HCPCS code J2675 for medical-claim billing (typically used when a product is administered in a clinical setting rather than dispensed at a retail pharmacy). See the Billing section on this page.
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.
← 00591-2990-60 · Actavis 00591-3137-60 · Actavis →
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.