Lupron Depot leuprolide acetate Kit — NDC 0074-3641-03 (Billing 00074-3641-03)
This is a package of Lupron Depot leuprolide acetate Kit from AbbVie Inc., marketed since Oct 1990 and currently FDA-listed; retail pharmacies pay about $1,822.08 per unit (NADAC). It is the main listing for this product, which comes in 2 package sizes.
NDC database record
One package, one record: these facts belong to NDC 0074-3641-03 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 0074 labeler · 3641 product · 03 package
- Package marketed since
- Oct 22, 1990
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Barcode (UPC-A, from the NDC)
- 3 0074364103 5
- Medicaid fills, this package
- 11,750 prescriptions in the last four reported quarters
- FDA record last changed
- Jul 24, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 045017
- GCN: 80254
- GPI-14 (Medi-Span): 21405010106405
- HICL (First Databank): 021102
- AHFS class code: 10:00.00.00
- RxCUI (RxNorm): 797544
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 5, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Other antiseptics and disinfectants class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
Leuprolide injection is used to treat certain types of prostate cancer central precocious puberty (CPP; a condition causing children to enter puberty too soon, resulting in faster than normal bone growth and development of sexual characteristics) endometriosis (a condition in which the type of tissue that lines the uterus [womb] grows in other areas of the body and causes infertility, pain before and during menstrual periods, pain during and after sexual activity, and heavy, irregular bleeding) anemia (a lower-than-normal number of red blood cells) caused by uterine fibroids (growths i...
Read the full MedlinePlus article ↗- That's a really common concern, and it's smart to ask. When you first start leuprolide, your testosterone levels actually spike for a week or two before the drug kicks in and bring...
- Why does my doctor say my symptoms might get worse right after starting leuprolide?
- Hot flashes are actually one of the most common side effects in men taking leuprolide — over half of men in clinical studies experienced them. Because leuprolide drops testosterone...
- Will I get hot flashes? I thought that was just a women's issue.
Patient education
Supplement & herbal interactions
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 5, 2026
Ask a licensed pharmacist directly — free, answered by our team.
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 system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $1,822.080 | — |
| Medicaid paysCMS SDUD · 12 mo | $1,613.28 | — |
| Medicare drug plans payPart D · Q2 2026 | $1,858.88 | — |
| Medicare Part B allowsASP · J1950 | $1,841.261 / J1950 unit | — |
Where does this data come from?
- CMS NADAC weekly file · file of Sep 30, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Billing & reimbursement
Where does this data come from?
- CMS ASP NDC-HCPCS crosswalk · refreshed Sep 22, 2026
- DMEPDAC NDC-HCPCS crosswalk
- openFDA NSDE billing units · refreshed Sep 7, 2026
Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Marketing end | Status |
|---|---|---|---|---|---|---|
| 00074-3641-03 You're viewing this Main listing | 1 KIT in 1 CARTON * 1 mL in 1 SYRINGE * 1 mL in 1 PACKET | $1,822.08 / ea | — | 1990-10-22 | — | Active |
| 00074-3641-71 0074-3641-71 | 1 KIT in 1 CARTON * 1 mL in 1 SYRINGE * 1 mL in 1 PACKET Sample | — | — | 1990-10-22 | — | Active |
In Medicaid, this is the most-dispensed pack of this product — about 100% of fills over the last four reported quarters. See all packs ↓
Pack size FAQ
What quantity is in this package?
What NDC number is used to bill for this package of Lupron Depot leuprolide acetate Kit?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Leuprolide Acetate 00781-4003-32 | Sandoz | 1 kit | $197.606 | AP | Availability likely | save 89% |
| Leuprolide Acetate 55150-0478-01 | Eugia | 1 kit | $197.606 | AP | Availability likely | save 89% |
| leuprolide acetate 47335-0936-40 | Sun | 1 kit | $197.606 | AP | Availability likely | save 89% |
| Leuprolide Acetate 70710-1769-03 | Zydus | 1 kit | $197.606 | AP | Availability likely | save 89% |
| Leuprolide Acetate 72664-0611-28 | VGYAAN | 1 kit | $261.318 | AP | FDA listed | save 86% |
| Lupron Depotthis 00074-3641-03 | AbbVie | 1 kit | $1,822.080 | — | Availability likely | — |
| Lupron Depot 00074-3642-03 | AbbVie | 1 kit | $2,174.170 | — | Availability likely | +19% |
| Lupron Depot 00074-3663-03 | AbbVie | 1 kit | $5,437.400 | — | Availability likely | +198% |
| Lupron Depot 00074-3346-03 | AbbVie | 1 kit | $6,516.300 | — | Availability likely | +258% |
| Fensolvi 62935-0153-50 | TOLMAR | 1 kit | — | — | FDA listed | — |
| Lupron Depot 00074-3473-03 | AbbVie | 1 kit | — | — | FDA listed | — |
| Lupron Depot-PED 00074-9694-03 | AbbVie | 1 kit | — | — | FDA listed | — |
| Lupron Depot-PED 00074-2108-03 | AbbVie | 1 kit | — | — | FDA listed | — |
| Lupron Depot-PED 00074-2440-03 | AbbVie | 1 kit | — | — | FDA listed | — |
| Lupron Depot 00074-3683-03 | AbbVie | 1 kit | — | — | FDA listed | — |
| Leuprolide Acetate Depot 69097-0909-50 | CIPLA | 1 kit | — | — | FDA listed | — |
| Lutrate Depot 83831-0134-01 | Avyxa | 1 kit | — | — | FDA listed | — |
| Lupron Depot-PED 00074-3575-01 | AbbVie | 1 kit | — | — | FDA listed | — |
| Leuprolide Acetate 70771-1687-03 | Zydus | 1 kit | — | AP | FDA listed | — |
| Lupron Depot-PED 00074-2282-03 | AbbVie | 1 kit | — | — | FDA listed | — |
| Lupron Depot-PED 00074-3779-03 | AbbVie | 1 kit | — | — | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file · file of Sep 30, 2026
Availability & generic status
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?
- FDA Orange Book · refreshed Oct 3, 2026
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.
Where does this data come from?
IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.- FDA label on DailyMed · label index refreshed Oct 5, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
More NDCs from AbbVie Inc. labeler code 00074
- Gengraf Cyclosporine 25 mg Capsule NDC 0074-3108-32
- Gengraf Cyclosporine 100 mg Capsule NDC 0074-3109-32
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- Norvir Ritonavir 100 mg Powder NDC 0074-3399-30
- Lupron Depot leuprolide acetate Kit NDC 0074-3473-03
- Lupron Depot-PED leuprolide acetate Kit NDC 0074-3575-01
- Lupron Depot leuprolide acetate Kit NDC 0074-3642-03
- Lupron Depot leuprolide acetate Kit NDC 0074-3663-03
- Lupron Depot leuprolide acetate Kit NDC 0074-3683-03
- Synthroid Levothyroxine Sodium 137 ug Tablet NDC 0074-3727-19
- Lupron Depot-PED leuprolide acetate Kit NDC 0074-3779-03
- Humira Adalimumab Kit NDC 0074-3799-02
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE LUPRON DEPOT 3.75 mg is a gonadotropin-releasing hormone (GnRH) agonist indicated for: Endometriosis Management of endometriosis, including pain relief and reduction of endometriotic lesions. ( 1.1 ) In combination with a norethindrone acetate for initial management of the painful symptoms of endometriosis and for management of recurrence of symptoms. ( 1.1 ) Limitations of Use: The total duration of therapy with LUPRON DEPOT 3.75 mg plus add-back therapy should not exceed 12 months due to concerns about adverse impact on bone mineral density.
( 1.1 , 2.1 , 5.1 ) Uterine Leiomyomata (Fibroids) Concomitant use with iron therapy for preoperative hematologic improvement of women with anemia caused by fibroids for whom three months of hormonal suppression is deemed necessary. ( 1.2 ) Limitations of Use: LUPRON DEPOT 3.75 mg is not indicated for combination use with norethindrone acetate add-back therapy for the preoperative hematologic improvement of women with anemia caused by heavy menstrual bleeding due to fibroids. ( 1.2 )
1.1Endometriosis Monotherapy LUPRON DEPOT 3.75 mg is indicated for management of endometriosis, including pain relief and reduction of endometriotic lesions. In Combination with Norethindrone Acetate LUPRON DEPOT 3.75 mg in combination with norethindrone acetate is indicated for initial management of the painful symptoms of endometriosis and for management of recurrence of symptoms. Use of norethindrone acetate in combination with LUPRON DEPOT 3.75 mg is referred to as add-back therapy, and is intended to reduce the loss of bone mineral density (BMD) and reduce vasomotor symptoms associated with use of LUPRON DEPOT 3.75 mg.
Limitations of Use : The total duration of therapy with LUPRON DEPOT 3.75 mg plus add-back therapy should not exceed 12 months due to concerns about adverse impact on bone mineral density [see Dosage and Administration ( 2.1 ) and Warnings and Precautions ( 5.1 ) ] .
1.2Uterine Leiomyomata (Fibroids) LUPRON DEPOT 3.75 mg, used concomitantly with iron therapy, is indicated for the preoperative hematologic improvement of women with anemia caused by fibroids for whom three months of hormonal suppression is deemed necessary. Consider a one-month trial period on iron alone, as some women will respond to iron alone [see Clinical Studies ( 14.2 )] . LUPRON DEPOT 3.75 mg may be added if the response to iron alone is considered inadequate.
Limitations of Use : LUPRON DEPOT 3.75 mg is not indicated for combination use with norethindrone acetate add-back therapy for the preoperative hematologic improvement of women with anemia caused by heavy menstrual bleeding due to fibroids [see Dosage and Administration ( 2.1 )] .
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION LUPRON DEPOT 3.75 mg for 1-month administration, given by a healthcare provider as a single intramuscular injection. LUPRON DEPOT 3.75 mg has different release characteristics than LUPRON 11.25 mg and is dosed differently. ( 2.1 ) Do not substitute LUPRON DEPOT 3.75 mg for LUPRON DEPOT 11.25 mg.
Do not administer LUPRON DEPOT 3.75 mg more frequently than once a month. Do not give a fractional dose of the LUPRON DEPOT 11.25 mg 3-month formulation, as it is not equivalent to a single dose of the LUPRON DEPOT 3.75 mg. Do not give a triple dose of the LUPRON DEPOT 3.75 mg, as it is not equivalent to a single dose of the LUPRON DEPOT 11.25 mg 3- month formulation.
Reconstitute LUPRON DEPOT 3.75 mg prior to use. ( 2.2 ) Endometriosis: LUPRON DEPOT 3.75 mg administered as a single intramuscular (IM) injection once every month for up to six injections (6 months of therapy). LUPRON DEPOT may be administered alone or in combination with daily 5 mg tablet of norethindrone acetate (add-back).
( 2.1 ) If endometriosis symptoms recur after initial course of therapy, retreatment for no more than six months may be considered but only with the addition of norethindrone acetate add-back therapy. Do not re-treat with LUPRON DEPOT 3.75 mg alone. ( 2.1 ) Fibroids: Recommended dose of LUPRON DEPOT 3.75 mg is one IM injection every month for up to three months.
( 2.1 ) Figure A Figure B Figure C Figure D Figure E Figure F Figure G
2.1Important Use Information LUPRON DEPOT 3.75 mg must be administered by a healthcare professional. LUPRON DEPOT 3.75 mg for 1-month administration has different release characteristics than LUPRON 11.25 mg for 3-month administration and is dosed differently. Do not substitute LUPRON DEPOT 3.75 mg for LUPRON DEPOT 11.25 mg.
Do not administer LUPRON DEPOT 3.75 mg more frequently than once a month. Do not give a fractional dose of the LUPRON DEPOT 11.25 mg 3-month formulation as it is not equivalent to a single dose of the LUPRON DEPOT 3.75 mg. Do not give a triple dose of the LUPRON DEPOT 3.75 mg, as it is not equivalent to a single dose of the LUPRON DEPOT 11.25 mg 3-month formulation.
Endometriosis The initial and retreatment dosage regimens for LUPRON DEPOT 3.75 mg for the management of women with endometriosis are outlined in Table 1. Table 1. LUPRON DEPOT 3.75 mg, Management of Endometriosis Treatment Phase LUPRON DEPOT 3.75 mg Dosing Maximum Treatment Duration Initial Treatment 1 3.75 mg IM every 1 month for 1 to 6 doses 6 months Retreatment 2 3.75 mg IM every 1 month for 1 to 6 doses 6 months 12 MONTHS 3 TOTAL TREATMENT DURATION 1 May use LUPRON DEPOT 3.75 mg with or without norethindrone acetate 5 mg tablet taken daily.
2 Use LUPRON DEPOT 3.75 mg with norethindrone acetate for retreatment 5 mg tablet taken daily [see Warnings and Precautions ( 5.1 ) ] and assess bone mineral density (BMD) prior to retreatment. 3 Treatment should not exceed 12 months due to concerns about adverse impact on bone mineral density. Fibroids The recommended dosage of LUPRON DEPOT 3.75 mg is one IM injection every month for up to three months.
2.2Reconstitution and Administration for Injection of LUPRON DEPOT Reconstitute and administer the lyophilized microsphere as a single IM injection as directed below. Visually inspect the drug product for particulate matter and discoloration prior to administration, whenever solution and container permit. Inject the LUPRON DEPOT 3.75 mg suspension immediately or discard if not used within two hours as the suspension does not contain a preservative.
1. Visually inspect the LUPRON DEPOT 3.75 mg powder. Do not use the syringe if clumping or caking is evident.
A thin layer of powder on the wall of the syringe is considered normal prior to mixing with the diluent. The diluent should appear clear. 2.
To prepare for injection, screw the white plunger into the end stopper until the stopper begins to turn (see Figure A and Figure B ). Figure A: Figure B: 3. Hold the syringe UPRI… [Excerpted — this section continues on DailyMed.]
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS For Injection: 3.75 mg of leuprolide acetate as a white lyophilized microsphere powder for reconstitution in a single dose prefilled dual chamber syringe; with one chamber containing the lyophilized powder and the other chamber containing the clear diluent. Depot suspension for injection: 3.75 mg lyophilized powder for reconstitution in a dual-chamber syringe. ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS LUPRON DEPOT 3.75 mg is contraindicated in women with the following: Hypersensitivity to gonadotropin-releasing hormone (GnRH), GnRH agonist analogs, including leuprolide acetate, or any of the excipients in LUPRON DEPOT 3.75 mg [see Warnings and Precautions ( 5.4 ) and Adverse Reactions ( 6.2 ) ] Undiagnosed abnormal uterine bleeding Pregnancy [see Warnings and Precautions ( 5.2 ) and Use in Specific Populations ( 8.1 ) ] When norethindrone acetate is administered with LUPRON DEPOT 3.75 mg, the contraindications to the use of norethindrone acetate also apply to this combination regimen.
Refer to the norethindrone acetate prescribing information for a list of contraindications for norethindrone acetate. Hypersensitivity to GnRH, GnRH agonist analogs, including leuprolide acetate, or any of the excipients in LUPRON DEPOT 3.75 mg. ( 4 , 5.4 ) Undiagnosed abnormal uterine bleeding.
( 4 ) Pregnancy. ( 4 , 8.1 ) If LUPRON DEPOT 3.75 mg is administered with norethindrone acetate, the contraindications for norethindrone acetate also apply. ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Loss of bone mineral density (BMD): Duration of treatment is limited by risk of bone mineral density. When using for management of endometriosis: combination use with norethindrone acetate is effective in reducing loss of BMD; do not retreat without combination norethindrone acetate. Assess BMD before retreatment.
( 1.1 , 1.2 , 5.1 ) Embryo-Fetal Toxicity: May cause fetal harm. Exclude pregnancy before initiating treatment if clinically indicated and discontinue use if pregnancy occurs. Use non-hormonal methods of contraception only.
( 5.2 ) Severe Cutaneous Adverse Reactions (SCARs), including Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN), occurred in patients treated with LUPRON DEPOT. Discontinue LUPRON DEPOT 3.75 mg if signs or symptoms of SCARs develop. Permanently discontinue if SCARs are confirmed.
( 5.3 ) Hypersensitivity reactions, including anaphylaxis, have been reported with LUPRON DEPOT 3.75 mg. ( 5.4 ) If LUPRON is administered with norethindrone acetate, the warnings and precautions for norethindrone acetate apply to the combination regimen. ( 5.8 )
5.1Loss of Bone Mineral Density LUPRON DEPOT 3.75 mg induces a hypoestrogenic state that results in loss of bone mineral density (BMD), some of which may not be reversible after stopping treatment. In women with major risk factors for decreased BMD such as chronic alcohol use (> 3 units per day), tobacco use, strong family history of osteoporosis, or chronic use of drugs that can decrease BMD, such as anticonvulsants or corticosteroids, use of LUPRON DEPOT 3.75 mg may pose an additional risk. Carefully weigh the risks and benefits of LUPRON DEPOT 3.75 mg use in these populations.
The duration of LUPRON DEPOT 3.75 mg treatment is limited by the risk of loss of bone mineral density [see Dosage and Administration ( 2.1 )] . When using LUPRON DEPOT 3.75 mg for the management of endometriosis, combination use of norethindrone acetate (add-back therapy) is effective in reducing the loss of BMD that occurs with leuprolide acetate [see Clinical Studies ( 14.2 )] . Do not retreat with LUPRON DEPOT 3.75 mg without combination norethindrone acetate.
Assess BMD before retreatment.
5.2Embryo-Fetal Toxicity Based on animal reproduction studies and the drug’s mechanism of action, LUPRON DEPOT 3.75 mg may cause fetal harm if administered to a pregnant woman and is contraindicated in pregnant women. Exclude pregnancy prior to initiating treatment with LUPRON DEPOT 3.75 mg if clinically indicated. Discontinue LUPRON DEPOT 3.75 mg if the woman becomes pregnant during treatment and inform the woman of potential risk to the fetus [see Contraindications ( 4 ) and Use in Specific Populations ( 8.1 ) ] .
Advise women to notify their healthcare provider if they believe they may be pregnant. When used at the recommended dose and dosing interval, LUPRON DEPOT 11.25 mg usually inhibits ovulation and stops menstruation. Contraception, however, is not ensured by taking LUPRON DEPOT 11.25 mg.
If contraception is indicated, advise women to use non-hormonal methods of contraception while on treatment with LUPRON DEPOT 3.75 mg.
5.3Severe Cutaneous Adverse Reactions Severe cutaneous adverse reactions (SCARs) have been reported in patients receiving GnRH agonists, including LUPRON DEPOT. These reactions include Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP), including cases with visceral involvement and/or requiring skin grafts [see Adverse Reactions ( 6.2 )] . Monitor patients for the signs and symptoms of SCARs such as fever, flu-like symptoms, mucosal lesions, progressive skin rash, or lymphadenopathy.
Advise patients of the signs and symptoms of SCARs. If a SCAR is suspected, discontinue LUPRON DEPOT 3.75 mg. Consult with a healthcare provider with expertise in the diagnosis and management of SCARs.
If a diagnosis of SCAR… [Excerpted — this section continues on DailyMed.]
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Loss of Bone Mineral Density [see Warnings and Precautions ( 5.1 )] Severe Cutaneous Adverse Reactions [see Warnings and Precautions ( 5.3 )] Hypersensitivity Reactions [see Warnings and Precautions ( 5.4 ) ] Initial Flare of Symptoms with Management of Endometriosis [see Warnings and Precautions ( 5.5 ) ] Convulsions [see Warnings and Precautions ( 5.6 ) ] Clinical Depression [see Warnings and Precautions ( 5.7 ) ] Most common adverse reactions (>10%) in clinical trials were hot flashes/sweats, headache/migraine, vaginitis, depression/emotional lability, general pain, weight gain/loss, nausea/vomiting, decreased libido, and dizziness.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact AbbVie Inc. at 1-800-633-9110 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. LUPRON DEPOT 3.75 mg (Monotherapy) The safety of LUPRON DEPOT 3.75 mg for the endometriosis and fibroids indications was established based on adequate and well-controlled adult studies. The safety of LUPRON DEPOT 3.75 mg was evaluated in six clinical studies in which a total of 332 women were treated for up to six months.
Women were treated with monthly IM injections of LUPRON DEPOT 3.75 mg. The population age range was 18 to 53 years old. Adverse Reactions (>1%) Leading to Study Discontinuation In the six studies 1.8% of women treated with LUPRON DEPOT 3.75 mg discontinued prematurely due to hot flashes.
Common Adverse Reactions The safety of LUPRON DEPOT 3.75 mg was evaluated in controlled clinical trials in 166 women with endometriosis and 166 women with uterine fibroids. Adverse reactions reported in ≥ 5% of women in either of these populations are noted in Tables 2 and 3 , below. Table 2.
Adverse Reactions Reported in ≥ 5% of Women with Endometriosis Taking LUPRON DEPOT 3.75 mg - 2 Studies LUPRON DEPOT 3.75 mg N=166 Danazol N=136 Placebo N=31 % % % Hot flashes/sweats* 84 57 29 Headache* 32 22 6 Vaginitis* 28 17 0 Depression/emotional lability* 22 20 3 General pain 19 16 3 Weight gain/loss 13 26 0 Nausea/vomiting 13 13 3 Decreased libido* 11 4 0 Dizziness 11 3 0 Acne 10 20 0 Skin reactions 10 15 3 Joint disorder* 8 8 0 Edema 7 13 3 Paresthesias 7 8 0 GI disturbances* 7 6 3 Neuromuscular disorders* 7 13 0 Breast changes/tenderness/pain* 6 9 0 Nervousness* 5 8 0 In these same studies, symptoms reported in < 5% of women included: Body as a Whole - Injection site reactions Cardiovascular System - Palpitations, syncope, tachycardia Digestive System - Appetite changes, dry mouth, thirst Endocrine System - Androgen-like effects, lactation Blood and Lymphatic System - Ecchymosis Nervous/Psychiatric System - Anxiety*, insomnia/sleep disorders*, delusions, memory disorder, personality disorder Dermal System - Alopecia, hair disorder Ocular system - Ophthalmologic disorders* Urogenital System - Dysuria*. * = Possible effect of decreased estrogen.
Table 3. Adverse Reactions Reported in ≥ 5% of Women with Uterine Fibroids (4 Studies) Taking LUPRON DEPOT 3.75 mg LUPRON DEPOT 3.75 mg N=166 Placebo N=163 % % Hot flashes/sweats* 73 18 Headache* 26 18 Vaginitis* 11 2 Depression/emotional lability* 11 4 Asthenia 8 5 General pain 8 6 Joint disorder* 8 3 Edema 5 1 Nausea/vomiting 5 4 Nervousness* 5 1 In these same studies, symptoms reported in < 5% of women included: Body as a Whole - Body odor, flu syndrome, injection site reactions Cardiovascular System - Tachycardia Digestive System - Appetite changes, dry mouth, taste perversion Endocrine System - Androgen-like effects, menstrual disorders Nervous/Psychiatric System - Anxiety*, insomnia/sleep disorders* Respiratory… [Excerpted — this section continues on DailyMed.]
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS No drug-drug interaction studies have been conducted with LUPRON DEPOT 3.75 mg.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Risk Summary LUPRON DEPOT 3.75 mg is contraindicated in pregnancy [see Contraindications ( 4 ) ] . LUPRON DEPOT 3.75 mg may cause fetal harm based on findings from animal studies and the drug’s mechanism of action [see Clinical Pharmacology ( 12.1 ) ] . There are limited human data on the use of LUPRON DEPOT in pregnant women.
Based on animal reproduction studies, LUPRON DEPOT 3.75 mg may be associated with an increased risk of pregnancy complications, including early pregnancy loss and fetal harm. In animal reproduction studies, subcutaneous administration of leuprolide acetate to rabbits during the period of organogenesis caused embryo-fetal toxicity, decreased fetal weights and a dose-dependent increase in major fetal abnormalities in animals at doses less than the recommended human dose based on body surface area using an estimated daily dose.
A similar rat study also showed increased fetal mortality and decreased fetal weights but no major fetal abnormalities at doses less than the recommended human dose based on body surface area using an estimated daily dose [see Data ] . Data Animal Data When administered on day 6 of pregnancy at test dosages of 0.00024 mg/kg, 0.0024 mg/kg, and 0.024 mg/kg (1/300 to 1/3 of the human dose) to rabbits, leuprolide acetate produced a dose-related increase in major fetal abnormalities. Similar studies in rats failed to demonstrate an increase in fetal malformations.
There was increased fetal mortality and decreased fetal weights with the two higher doses of LUPRON DEPOT in rabbits and with the highest dose (0.024 mg/kg) in rats.
8.2Lactation Risk Summary There are no data on the presence of leuprolide acetate in either animal or human milk, the effects on the breastfed infants, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for LUPRON DEPOT 3.75 mg and any potential adverse effects on the breastfed infant from LUPRON DEPOT 3.75 mg or from the underlying maternal condition.
8.3Females and Males of Reproductive Potential Pregnancy Testing Exclude pregnancy in women of reproductive potential prior to initiating LUPRON DEPOT 3.75 mg if clinically indicated [see Warnings and Precautions ( 5.2 ) ] . Contraception Females LUPRON DEPOT 3.75 mg may cause embryo-fetal harm when administered during pregnancy. LUPRON DEPOT 3.75 mg is not a contraceptive.
If contraception is indicated, advise females of reproductive potential to use a non-hormonal method of contraception during treatment with LUPRON DEPOT 3.75 mg [see Warnings and Precautions ( 5.2 ) ] . Infertility Based on its pharmacodynamic effects of decreasing secretion of gonadal steroids, fertility is expected to be decreased while on treatment with LUPRON DEPOT 3.75 mg. Clinical and pharmacologic studies in adults (>18 years) with leuprolide acetate and similar analogs have shown reversibility of fertility suppression when the drug is discontinued after continuous administration for periods of up to 24 weeks [see Clinical Pharmacology ( 12.1 ) ] .
There is no evidence that pregnancy rates are affected following discontinuation of LUPRON DEPOT 3.75 mg. Animal studies (prepubertal and adult rats and monkeys) with leuprolide acetate and other GnRH analogs have shown functional recovery of fertility suppression.
8.4Pediatric Use Safety and effectiveness of LUPRON DEPOT 3.75 mg for management of endometriosis and the preoperative hematologic improvement of women with anemia caused by fibroids have been established in females of reproductive age. Efficacy is expected to be the same for postpubertal adolescents under the age of 18 as for users 18 years and older. The safety and effectiveness of LUPRON DEPOT 3.75 mg for these indications have not been established in premenarcheal pediatric patients.
8.5Geriatric Use LUPRON DEPOT 3.75 mg is not indicated in postmenopausal women and has not been studied in… [Excerpted — this section continues on DailyMed.]
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary LUPRON DEPOT 3.75 mg is contraindicated in pregnancy [see Contraindications ( 4 ) ] . LUPRON DEPOT 3.75 mg may cause fetal harm based on findings from animal studies and the drug’s mechanism of action [see Clinical Pharmacology ( 12.1 ) ] . There are limited human data on the use of LUPRON DEPOT in pregnant women.
Based on animal reproduction studies, LUPRON DEPOT 3.75 mg may be associated with an increased risk of pregnancy complications, including early pregnancy loss and fetal harm. In animal reproduction studies, subcutaneous administration of leuprolide acetate to rabbits during the period of organogenesis caused embryo-fetal toxicity, decreased fetal weights and a dose-dependent increase in major fetal abnormalities in animals at doses less than the recommended human dose based on body surface area using an estimated daily dose.
A similar rat study also showed increased fetal mortality and decreased fetal weights but no major fetal abnormalities at doses less than the recommended human dose based on body surface area using an estimated daily dose [see Data ] . Data Animal Data When administered on day 6 of pregnancy at test dosages of 0.00024 mg/kg, 0.0024 mg/kg, and 0.024 mg/kg (1/300 to 1/3 of the human dose) to rabbits, leuprolide acetate produced a dose-related increase in major fetal abnormalities. Similar studies in rats failed to demonstrate an increase in fetal malformations.
There was increased fetal mortality and decreased fetal weights with the two higher doses of LUPRON DEPOT in rabbits and with the highest dose (0.024 mg/kg) in rats.
🧒 Pediatric Use ▾
8.4Pediatric Use Safety and effectiveness of LUPRON DEPOT 3.75 mg for management of endometriosis and the preoperative hematologic improvement of women with anemia caused by fibroids have been established in females of reproductive age. Efficacy is expected to be the same for postpubertal adolescents under the age of 18 as for users 18 years and older. The safety and effectiveness of LUPRON DEPOT 3.75 mg for these indications have not been established in premenarcheal pediatric patients.
🧓 Geriatric Use ▾
8.5Geriatric Use LUPRON DEPOT 3.75 mg is not indicated in postmenopausal women and has not been studied in this population.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Leuprolide acetate is a long-acting GnRH analog. A single monthly injection of LUPRON DEPOT 3.75 mg results in an initial stimulation followed by a prolonged suppression of pituitary gonadotropins. Repeated dosing of LUPRON DEPOT 3.75 mg at monthly intervals results in decreased secretion of gonadal steroid.
Consequently, tissues and functions that depend on gonadal steroids for their maintenance become quiescent. This effect is reversible on discontinuation of drug therapy. Leuprolide acetate is not active when given orally.
12.2Pharmacodynamics Administration of LUPRON DEPOT 3.75 mg in therapeutic doses results in suppression of the pituitary-gonadal system. Normal function is usually restored within three months after treatment is discontinued. Therefore, diagnostic tests of pituitary gonadotropic and gonadal functions conducted during treatment and for up to three months after discontinuation of LUPRON DEPOT 3.75 mg may be affected.
12.3Pharmacokinetics Absorption Following a single IM injection of LUPRON DEPOT 3.75 mg in healthy female volunteers, absorption of leuprolide was characterized by an initial increase in plasma concentration, with peak concentration ranging from 4.6 to 10.2 ng/mL at four hours postdosing. However, intact leuprolide and an inactive metabolite could not be distinguished by the assay used in the study. Following the initial rise, leuprolide concentrations started to plateau within two days after dosing and remained relatively stable for about four to five weeks with plasma concentrations of about 0.30 ng/mL.
Distribution The mean steady-state volume of distribution of leuprolide following intravenous bolus administration to healthy male volunteers was 27 L. In vitro binding to human plasma proteins ranged from 43% to 49%. Metabolism Leuprolide acetate is a peptide that is primarily degraded by peptidase.
In healthy male volunteers, a 1 mg bolus of leuprolide administered intravenously revealed that the mean systemic clearance was
7.6L/h, with a terminal elimination half-life of approximately 3 hours based on a two-compartment model. The major metabolite (M-I, a pentapeptide) plasma concentrations measured in 5 prostate cancer patients reached maximum concentration 2 to 6 hours after dosing and were approximately 6% of the peak parent drug concentration. One week after dosing, mean plasma M-I concentrations were approximately 20% of mean leuprolide concentrations.
Excretion Following administration of LUPRON DEPOT 3.75 mg to 3 patients, less than 5% of the dose was recovered as parent and M-I metabolite in the urine. Use in Specific Populations The pharmacokinetics of LUPRON DEPOT have not been evaluated in patients with hepatic and renal impairment. Drug Interactions No pharmacokinetic drug-drug interaction studies have been conducted with LUPRON DEPOT 3.75 mg.
However, leuprolide acetate is a peptide that is not degraded by cytochrome P-450 enzymes; hence, drug interactions associated with cytochrome P-450 enzymes would not be expected to occur.
🧬 Mechanism of Action ▾
12.1Mechanism of Action Leuprolide acetate is a long-acting GnRH analog. A single monthly injection of LUPRON DEPOT 3.75 mg results in an initial stimulation followed by a prolonged suppression of pituitary gonadotropins. Repeated dosing of LUPRON DEPOT 3.75 mg at monthly intervals results in decreased secretion of gonadal steroid.
Consequently, tissues and functions that depend on gonadal steroids for their maintenance become quiescent. This effect is reversible on discontinuation of drug therapy. Leuprolide acetate is not active when given orally.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Each LUPRON DEPOT 3.75 mg kit (NDC 0074-3641-03) contains: one prefilled dual-chamber syringe one plunger two alcohol swabs Each single-dose dual chamber syringe contains sterile white lyophilized microsphere powder of 3.75 mg of leuprolide acetate incorporated in a biodegradable polymer in one chamber and a colorless diluent (1 mL) in the other chamber. When mixed with the diluent, LUPRON DEPOT 3.75 mg for injection, is administered as a single IM injection. Store between 20° to 25°C (68° to 77°F).
Excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature] .
📋 Description ▾
11 DESCRIPTION Leuprolide acetate is a synthetic nonapeptide analog of gonadotropin-releasing hormone [GnRH or luteinizing hormone releasing hormone (LH-RH)], a GnRH agonist. The chemical name is 5- oxo-L-prolyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-D-leucyl-L-leucyl-L-arginyl-N-ethyl-L-prolinamide acetate (salt) with the following structural formula: LUPRON DEPOT 3.75 mg (leuprolide acetate for depot suspension for injection) is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres powder which, when mixed with diluent, become a suspension intended as an IM injection.
The front chamber of LUPRON DEPOT 3.75 mg prefilled dual-chamber syringe contains leuprolide acetate for depot suspension (3.75 mg), purified gelatin (0.65 mg), DL-lactic and glycolic acids copolymer (33.1 mg) and D-mannitol (6.6 mg). The second chamber of diluent contains carboxymethylcellulose sodium (5 mg), D-mannitol (50 mg), polysorbate 80 (1 mg), water for injection, USP, and glacial acetic acid, USP to control pH. During the manufacture of LUPRON DEPOT 3.75 mg, acetic acid is lost, leaving the peptide. structural formula
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Loss of Bone Density Advise patients about the risk of loss of bone mineral density and that treatment is limited [see Dosage and Administration ( 2.1 ) ] . Advise patients about other factors that can increase and decrease their risk of bone mineral density loss [see Warnings and Precautions ( 5.1 ) ] . Embryo-Fetal Toxicity Advise females of reproductive potential of the possible risk to a fetus.
Advise patients to inform healthcare provider of a known or suspected pregnancy [see Warnings and Precautions ( 5.2 ) and Use in Special Populations ( 8.1 ) ] . If contraception is indicated, advise females of reproductive potential to use non-hormonal contraception during treatment with LUPRON DEPOT 3.75 mg [see Use in Special Populations ( 8.3 ) ] . Severe Cutaneous Adverse Reactions Inform patients that severe cutaneous adverse reactions (SCARs) may occur during treatment with LUPRON DEPOT 3.75 mg.
Advise patients to discontinue LUPRON DEPOT 3.75 mg and immediately contact their healthcare provider if they experience signs or symptoms of SCARs [ see Warnings and Precautions ( 5.3 ) ]. Hypersensitivity Reactions Inform patients that hypersensitivity reactions, including anaphylaxis, have been reported with LUPRON DEPOT. Advise patients to seek appropriate medical care if symptoms of hypersensitivity reactions occur [see Warnings and Precautions ( 5.4 ) and Adverse Reactions ( 6.2 ) ].
Initial Flare of Symptoms Advise patients that they may experience an increase in symptoms during the initial days of therapy. Advise patients that these symptoms should dissipate with continued therapy [see Warnings and Precautions ( 5.5 ) ]. Convulsions Inform patients that convulsions have been reported in patients who have received LUPRON DEPOT.
Advise patients to seek medical attention in the event of a convulsion [see Warnings and Precautions ( 5.6 ) ] . Clinical Depression Inform patients that depression may occur or worsen during treatment with GnRH agonists, including LUPRON DEPOT 3.75 mg, especially in patients with a history of depression. Advise patients to immediately report thoughts and behaviors of concern to healthcare providers [see Warnings and Precautions ( 5.7 ) ] .
Manufactured for AbbVie Inc. North Chicago, IL 60064 by Takeda Pharmaceutical Company Limited Osaka, Japan 540-8645 Revised 09/2025 20085416
🧬 Pharmacokinetics ▾
12.3Pharmacokinetics Absorption Following a single IM injection of LUPRON DEPOT 3.75 mg in healthy female volunteers, absorption of leuprolide was characterized by an initial increase in plasma concentration, with peak concentration ranging from 4.6 to 10.2 ng/mL at four hours postdosing. However, intact leuprolide and an inactive metabolite could not be distinguished by the assay used in the study. Following the initial rise, leuprolide concentrations started to plateau within two days after dosing and remained relatively stable for about four to five weeks with plasma concentrations of about 0.30 ng/mL.
Distribution The mean steady-state volume of distribution of leuprolide following intravenous bolus administration to healthy male volunteers was 27 L. In vitro binding to human plasma proteins ranged from 43% to 49%. Metabolism Leuprolide acetate is a peptide that is primarily degraded by peptidase.
In healthy male volunteers, a 1 mg bolus of leuprolide administered intravenously revealed that the mean systemic clearance was
7.6L/h, with a terminal elimination half-life of approximately 3 hours based on a two-compartment model. The major metabolite (M-I, a pentapeptide) plasma concentrations measured in 5 prostate cancer patients reached maximum concentration 2 to 6 hours after dosing and were approximately 6% of the peak parent drug concentration. One week after dosing, mean plasma M-I concentrations were approximately 20% of mean leuprolide concentrations.
Excretion Following administration of LUPRON DEPOT 3.75 mg to 3 patients, less than 5% of the dose was recovered as parent and M-I metabolite in the urine. Use in Specific Populations The pharmacokinetics of LUPRON DEPOT have not been evaluated in patients with hepatic and renal impairment. Drug Interactions No pharmacokinetic drug-drug interaction studies have been conducted with LUPRON DEPOT 3.75 mg.
However, leuprolide acetate is a peptide that is not degraded by cytochrome P-450 enzymes; hence, drug interactions associated with cytochrome P-450 enzymes would not be expected to occur.
🧬 Pharmacodynamics ▾
12.2Pharmacodynamics Administration of LUPRON DEPOT 3.75 mg in therapeutic doses results in suppression of the pituitary-gonadal system. Normal function is usually restored within three months after treatment is discontinued. Therefore, diagnostic tests of pituitary gonadotropic and gonadal functions conducted during treatment and for up to three months after discontinuation of LUPRON DEPOT 3.75 mg may be affected.
🔬 Clinical Studies ▾
14 CLINICAL STUDIES The safety and efficacy of LUPRON DEPOT 3.75 mg for the indicated populations has been established based on adequate and well-controlled studies in adults (See Table 8 ) of LUPRON DEPOT 3.75 mg [see Indications and Usage ( 1 ) ] . Figure 1
14.1Endometriosis LUPRON DEPOT 3.75 mg Monotherapy In controlled clinical studies, LUPRON DEPOT 3.75 mg monthly for six months was shown to be comparable to danazol 800 mg/day in relieving the clinical sign/symptoms of endometriosis (pelvic pain, dysmenorrhea, dyspareunia, pelvic tenderness, and induration) and in reducing the size of endometrial implants as evidenced by laparoscopy. The clinical significance of a decrease in endometriotic lesions is not known, and laparoscopic staging of endometriosis does not necessarily correlate with the severity of symptoms.
LUPRON DEPOT 3.75 mg monthly induced amenorrhea in 74% and 98% of the women after the first and second month of treatment, respectively. Most of the remaining women reported episodes of only light bleeding or spotting. In the first, second and third post-treatment months, normal menstrual cycles resumed in 7%, 71% and 95% of women, respectively, excluding those who became pregnant.
Figure 1 illustrates the percent of women with symptoms at baseline, final treatment visit and sustained relief at 6 and 12 months following discontinuation of treatment for the various symptoms evaluated during the two controlled clinical studies. A total of 166 women received LUPRON DEPOT 3.75 mg. Seventy-five percent (N=125) of these elected to participate in the follow-up period.
Of these women, 36% and 24% are included in the 6-month and 12-month follow-up analysis, respectively. All the women who had a pain evaluation at baseline and at least of one treatment visit are included in the Baseline (B) and final treatment visit (F) analysis. Figure 1.
Percent of Women with Signs/Symptoms of Endometriosis at Baseline, Final Treatment Visit, and After 6 and 12 Months of Follow-Up, LUPRON DEPOT 3.75 mg Monthly for Six Months LUPRON DEPOT with Norethindrone Acetate Add-Back Therapy Two clinical studies with treatment duration of 12 months were conducted to evaluate the effect of co-administration of LUPRON DEPOT 3.75 mg and norethindrone acetate on the loss of bone mineral density (BMD) associated with LUPRON DEPOT 3.75 mg and on the efficacy of LUPRON DEPOT in relieving symptoms of endometriosis.
All women in these studies received calcium supplementation with 1000 mg elemental calcium. A total of 242 women were treated with monthly administration of LUPRON DEPOT 3.75 mg (13 injections) and 191 of them were co-administered 5 mg norethindrone acetate taken daily. The population age range was 17-43 years old.
The majority of women were Caucasian (87%). One co-administration study was a controlled, randomized and double-blind study included 51 women treated monthly with LUPRON DEPOT 3.75 mg alone and 55 women treated monthly with LUPRON DEPOT 3.75 mg plus norethindrone acetate daily. Women in this trial were followed for up to 24 months after completing one year of treatment.
The other study was an open-label single arm clinical study in 136 women of one year of treatment with LUPRON DEPOT 3.75 mg monthly and daily norethindrone acetate 5 mg, with follow-up for up to 12 months after completing treatment. See Table 8 . The assessment of efficacy was based on the investigator’s or the woman’s monthly assessment of five signs or symptoms of endometriosis (dysmenorrhea, pelvic pain, deep dyspareunia, pelvic tenderness and pelvic induration).
Table 8 below provides detailed efficacy data regarding relief of symptoms of endometriosis based on the two studies of co-administration of LUPRON DEPOT 3.75 mg monthly and norethindrone acetate 5 mg daily. Table 8. Effect of LUPRON DEPOT and Norethindrone Acetate on the Symptoms of Endometriosis and Mean Clinical Severity Scores Percent of Women with Symptoms Clinical Pain Severity Score Baseline Final B… [Excerpted — this section continues on DailyMed.]
🧪 Nonclinical Toxicology ▾
13 NONCLINICAL TOXICOLOGY
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility A two-year carcinogenicity study was conducted in rats and mice. In rats, a dose-related increase of benign pituitary hyperplasia and benign pituitary adenomas was noted at 24 months when the drug was administered subcutaneously at high daily doses (0.6 to 4 mg/kg). There was a significant but not dose-related increase of pancreatic islet-cell adenomas in females and of testicular interstitial cell adenomas in males (highest incidence in the low dose group).
In mice, no leuprolide acetate-induced tumors or pituitary abnormalities were observed at a dose as high as 60 mg/kg for two years. Patients have been treated with leuprolide acetate for up to three years with doses as high as 10 mg/day and for two years with doses as high as 20 mg/day without demonstrable pituitary abnormalities. Mutagenicity studies have been performed with leuprolide acetate using bacterial and mammalian systems.
These studies provided no evidence of a mutagenic potential.
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility A two-year carcinogenicity study was conducted in rats and mice. In rats, a dose-related increase of benign pituitary hyperplasia and benign pituitary adenomas was noted at 24 months when the drug was administered subcutaneously at high daily doses (0.6 to 4 mg/kg). There was a significant but not dose-related increase of pancreatic islet-cell adenomas in females and of testicular interstitial cell adenomas in males (highest incidence in the low dose group).
In mice, no leuprolide acetate-induced tumors or pituitary abnormalities were observed at a dose as high as 60 mg/kg for two years. Patients have been treated with leuprolide acetate for up to three years with doses as high as 10 mg/day and for two years with doses as high as 20 mg/day without demonstrable pituitary abnormalities. Mutagenicity studies have been performed with leuprolide acetate using bacterial and mammalian systems.
These studies provided no evidence of a mutagenic potential.
📄 Recent Major Changes ▾
Warnings and Precautions, Severe Cutaneous Adverse Reactions ( 5.3 ) 9/2025
📄 Package Label / Principal Display Panel ▾
PRINCIPAL DISPLAY PANEL NDC 0074-3641-03 FOR ADULT USE 3.75 mg for 1 - Month administration Single Dose Administration Kit with prefilled dual-chamber syringe. LupronDepot ® (leuprolide acetate for depot suspension) 3.75 mg for 1 - Month administration FOR INTRAMUSCULAR INJECTION The front chamber contains: leuprolide acetate 3.75 mg, purified gelatin 0.65 mg, DL-lactic & glycolic acids copolymer 33.1 mg, D-mannitol 6.6 mg The second chamber contains: D-mannitol 50 mg, carboxymethylcellulose sodium 5 mg, polysorbate 80 1 mg, water for injection, USP, and glacial acetic acid, USP to control pH Rx only NDC 0074-3641-03 FOR ADULT USE 3.75 mg for 1 - Month administration Single Dose Administration Kit with prefilled dual-chamber syringe.
LupronDepot® (leuprolide acetate for depot suspension) 3.75 mg for 1 - Month administration FOR INTRAMUSCULAR INJECTION The front chamber contains: leuprolide acetate 3.75 mg, purified gelatin 0.65 mg, DL-lactic & glycolic acids copolymer 33.1 mg, D-mannitol 6.6 mg The second chamber contains: D-mannitol 50 mg, carboxymethylcellulose sodium 5 mg, polysorbate 80 1 mg, water for injection, USP, and glacial acetic acid, USP to control pH Rx only
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