Regranex Gel 0.01% Becaplermin .1 mg/g Gel, 15 g
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Human Platelet-derived Growth Factor class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
Becaplermin gel is used as part of a total treatment program to help heal certain ulcers (sores) of the foot, ankle, or leg in people who have diabetes. Becaplermin gel must be used along with good ulcer care including: removal of dead tissue by a medical professional; the use of special shoes, walkers, crutches, or wheelchairs to keep weight off the ulcer; and treatment of any infections that develop. Becaplermin cannot be used to treat ulcers that have been stitched or stapled. Becaplermin is a human platelet-derived growth factor, a substance naturally produced by the body that helps in wou...
Read the full MedlinePlus article ↗- Regranex helps your body heal a diabetic ulcer that isn't closing on its own. It contains a growth factor — a protein signal — that tells your body's repair cells to move into the...
- What exactly is Regranex supposed to do for my ulcer?
- The amount depends on the size of your ulcer — specifically its length and width. Your doctor or wound care provider will do that calculation for you and show you how much to squee...
- How do I know how much gel to use each time?
Patient education
Supplement & herbal interactions
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
🧪 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.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
💲 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 g | Per 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. | |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Regranex Gel 0.01% .1 mg/gthis 85822-0734-15 | LRM | 15 g | — | — | FDA listed | — |
Where does this data come from?
⏳ Availability & biosimilar status
Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.
Where does this data come from?
🔬 Reported adverse events (FAERS)
Top reported reactions
Reporter sex
Serious outcomes
Where does this data come from?
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 85822-0734-15 You're viewing this | 15 g in 1 TUBE (85822-734-15) | 2025-06-30 | Active |
🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available. |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope. |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
Questions about this listing
Why is there no price listed?
Is the NDC printed on the package the same as the 11-digit billing NDC?
What do the three segments of this NDC mean?
Is this package still being marketed?
Who lists this product with the FDA?
Do I need a prescription for this product?
Where does this data come from?
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE REGRANEX is indicated for the treatment of lower extremity diabetic neuropathic ulcers that extend into the subcutaneous tissue or beyond and have an adequate blood supply, when used as an adjunct to, and not a substitute for, good ulcer care practices including initial sharp debridement, pressure relief and infection control. Limitations of Use: The efficacy of REGRANEX has not been established for the treatment of pressure ulcers and venous stasis ulcers [ see Clinical Studies ( 14.2 ) ] and has not been evaluated for the treatment of diabetic neuropathic ulcers that do not extend through the dermis into subcutaneous tissue [Stage I or II, International Association of Enterostomal Therapy (IAET) staging classification] or ischemic diabetic ulcers.
The effects of becaplermin on exposed joints, tendons, ligaments, and bone have not been established in humans [ see Nonclinical Toxicology ( 13.2 ) ]. REGRANEX is not intended to be used in wounds that close by primary intention. REGRANEX is a human platelet-derived growth factor indicated for the treatment of lower extremity diabetic neuropathic ulcers that extend into the subcutaneous tissue or beyond and have an adequate blood supply.
REGRANEX is indicated as an adjunct to, and not a substitute for, good ulcer care practices. ( 1 ) Limitations of Use: The efficacy of REGRANEX has not been established for the treatment of pressure ulcers and venous stasis ulcers. ( 1 ) The effects of REGRANEX on exposed joints, tendons, ligaments, and bone have not been established in humans.
( 1 ) REGRANEX is not intended to be used in wounds that close by primary intention. ( 1 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION REGRANEX is for topical use; it is not for oral, ophthalmic or intravaginal use. The amount of REGRANEX to be applied depends upon the size of the ulcer area. To calculate the length of gel to apply to the ulcer, measure the greatest length of the ulcer by the greatest width of the ulcer in either inches or centimeters.
To calculate the length of gel in inches, use the formula shown below in Table 1, and to calculate the length of gel in centimeters, use the formula shown below in Table 2. Table 1: Formula to Calculate Length of Gel in Inches to Be Applied Daily Tube Size INCHES Formula 15 g tube length × width ×
0.6Using the calculation, each square inch of ulcer surface will require approximately 2/3 inch length of gel squeezed from a 15 g tube. For example, if the ulcer measures 1 inch by 2 inches, then a 1 1/4 inch length of gel should be used for 15 g tubes (1 x 2 x 0.6 = 1 1/4). Table 2: Formula to Calculate Length of Gel in Centimeters to Be Applied Daily Tube Size CENTIMETERS Formula 15 g tube length × width ÷ 4 Using the calculations for ulcer size in centimeters, each square centimeter of ulcer surface will require approximately a 0.25 centimeter length of gel squeezed from a 15 g tube.
For example, if the ulcer measures 4 cm by 2 cm, then a 2 cm length of gel should be used for a 15 g tube [(4 x 2) ÷ 4 = 2]. The amount of REGRANEX to be applied should be recalculated by the physician or wound caregiver at weekly or biweekly intervals depending on the rate of change in ulcer area. The weight of REGRANEX from 15 g tubes is 0.65 g per inch length and 0.25 g per centimeter length.
To apply REGRANEX, the calculated length of gel should be squeezed on to a clean measuring surface, e.g., wax paper, and measured to the correct length with a ruler. The measured REGRANEX is transferred from the clean measuring surface using an application aid and then spread over the entire cleaned ulcer area to yield a thin continuous layer of approximately 1/16 of an inch thickness. The site(s) of application should then be covered by a saline moistened gauze dressing and left in place for approximately 12 hours.
The dressing should then be removed and the ulcer rinsed with saline or water to remove residual gel and covered again with a moist primary dressing (without REGRANEX gel) for the remainder of the day. REGRANEX should be applied once daily to the ulcer until complete healing has occurred. If the ulcer does not decrease in size by approximately 30% after 10 weeks of treatment or complete healing has not occurred in 20 weeks, continued treatment with REGRANEX should be reassessed.
The step-by-step instructions for applying REGRANEX in a home care setting can be found in the FDA-approved Instructions for Use. For topical use; not for oral, ophthalmic or intravaginal use. ( 2 ) To calculate the length of REGRANEX to apply, measure the greatest length of the ulcer by greatest width of the ulcer in either inches or centimeters.
( 2 ) Formula to Calculate Length of Gel to Be Applied Daily Tube Size Formula 15 g Tube Inches: ulcer length x ulcer width x 0.6 15 g Tube Centimeters: ulcer length x ulcer width ÷ 4
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Gel: 0.01%; clear, colorless to straw-colored Gel: 0.01% ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS REGRANEX is contraindicated in patients with known neoplasm(s) at the site(s) of application. Known neoplasm(s) at the site(s) of application ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Malignancies distant from the site of application have been reported in both a clinical study and in postmarketing use. ( 5.1 ) The benefits and risks of REGRANEX treatment should be carefully evaluated before prescribing in patients with known malignancy. ( 5.1 )
5.1Risk of Cancer REGRANEX contains becaplermin, a recombinant human platelet-derived growth factor, which promotes cellular proliferation and angiogenesis [ see Clinical Pharmacology ( 12.1 ) ]. Malignancies distant from the site of application have occurred in REGRANEX users in a clinical study and in postmarketing use [ see Adverse Reactions ( 6.1 ) and Clinical Studies ( 14.3 ) ]. The benefits and risks of REGRANEX treatment should be carefully evaluated before prescribing in patients with known malignancy.
5.2Application Site Reactions If application site reactions occur, the possibility of sensitization or irritation caused by parabens or m-cresol should be considered. Consider interruption or discontinuation and further evaluation (e.g. patch testing) as dictated by clinical circumstances.
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS Erythematous rashes occurred in 2% of patients treated with REGRANEX. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch, or Lynch Regenerative Medicine, LLC at 1-888-576-7343
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 practice. In clinical trials, erythematous rashes occurred in 2% of subjects treated with REGRANEX (and good ulcer care) or placebo (and good ulcer care), and none in subjects receiving good ulcer care alone. Subjects treated with REGRANEX did not develop neutralizing antibodies against becaplermin.
In a retrospective follow-up study of 491 of 651 subjects (75%) from two randomized, controlled trials of another formulation of becaplermin gel 0.01%, the subjects were followed for a median of approximately 20 months to evaluate safety and recurrence of healed diabetic lower extremity ulcers. Eight of 291 subjects (2.7%) from the becaplermin gel group and two of 200 subjects (1%) from the vehicle/standard of care group were diagnosed with cancers during the follow-up period, a relative risk of 2.7 (95% confidence interval [CI], 0.6-12.8).
The types of cancers varied and all were remote from the treatment site [see Warnings and Precautions ( 5.1 )] .
6.2Postmarketing Experience Because post-approval adverse reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to the drug. The following adverse reactions have been identified during post approval use of REGRANEX. Increased rate of death from systemic malignancies in patients dispensed 3 or more tubes of REGRANEX was observed in one of three retrospective postmarketing studies [ see Clinical Studies ( 14.3 ) ].
Burning sensation and erythema at the site of application have been reported.
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS It is not known if REGRANEX interacts with other topical medications applied to the ulcer site. The use of REGRANEX with other topical drugs has not been studied.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Risk Summary There are no available data on REGRANEX use in pregnant women to inform a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Animal reproduction studies have not been conducted with REGRANEX. The background risk of major birth defects and miscarriage for the indicated population is unknown.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
8.2Lactation There are no data on the presence of becaplermin in human milk, the effects on the breastfed infant, or the effects on milk production after topical application of REGRANEX to lactating women. The developmental and health benefits of breastfeeding should be considered along with the lactating woman's clinical need for REGRANEX and any potential adverse effects on the breastfed child from becaplermin.
8.4Pediatric Use Safety and effectiveness of REGRANEX in pediatric patients below the age of 16 years have not been established.
8.5Geriatric Use Among subjects receiving any dose of REGRANEX in clinical studies of diabetic lower extremity ulcers, 150 subjects were 65 years of age and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects. The number of subjects aged 75 and older was insufficient (n=34) to determine whether they respond differently from younger subjects.
🆘 Overdosage ▾
10 OVERDOSAGE There are no data on the effects of REGRANEX overdose.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action REGRANEX has biological activity similar to that of endogenous platelet-derived growth factor, which includes promoting the chemotactic recruitment and proliferation of cells involved in wound repair and enhancing the formation of granulation tissue.
12.2Pharmacodynamics Clinical pharmacodynamic studies have not been conducted.
12.3Pharmacokinetics Ten subjects with Stage III or IV [as defined in the International Association of Enterostomal Therapy (IAET) guide to chronic wound staging] lower extremity diabetic ulcers received topical applications of becaplermin gel 0.01% at a dose range of 0.32–2.95 mcg/kg (7 mcg/cm 2 ) daily for 14 days. Six subjects had non-quantifiable PDGF levels at baseline and throughout the study, two subjects had PDGF levels at baseline which did not increase substantially, and two subjects had PDGF levels that increased sporadically above their baseline values during the 14-day study period.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING REGRANEX (0.01%) is clear, colorless to straw-colored and is available in multi-use tubes in the following size: 15 g tube NDC 85822-734-15 Store refrigerated at 2° - 8°C (36° - 46°F). Do not freeze.
📋 Description ▾
11 DESCRIPTION REGRANEX contains becaplermin, a recombinant human platelet-derived growth factor, for topical administration. Becaplermin is produced by recombinant DNA technology by insertion of the gene for the B chain of platelet-derived growth factor (PDGF) into the yeast, Saccharomyces cerevisiae . Becaplermin has a molecular weight of approximately 25 kD and is a homodimer composed of two identical polypeptide chains that are bound together by disulfide bonds.
REGRANEX is a non-sterile, low bioburden, preserved, sodium carboxymethylcellulose-based (CMC) topical gel, containing the active ingredient becaplermin and the following inactive ingredients: carboxymethylcellulose sodium, acetic acid, l-lysine hydrochloride, m-cresol, methylparaben, propylparaben, sodium acetate, sodium chloride, and purified water. Each gram of REGRANEX contains 100 mcg of becaplermin.
💬 Medication Guide ▾
MEDICATION GUIDE REGRANEX ® (RE–GRANʹ–IX) (becaplermin) gel Important: REGRANEX is for use on the skin only (topical). Do not use REGRANEX near or in your mouth, eyes, or vagina. What is the most important information I should know about REGRANEX?
REGRANEX may cause serious side effects, including: Risk of cancer. Cancers have happened in areas away from the REGRANEX application site. You and your healthcare provider should carefully consider whether you will use REGRANEX if you have cancer.
What is REGRANEX? REGRANEX is a prescription medicine that is used with good ulcer care practice for the treatment of diabetic sores (ulcers) of your legs or feet that are deeper than just your skin, in people who have good blood supply to the legs and feet. It is not known if REGRANEX is effective for the treatment of pressure ulcers or ulcers that are due to poor blood flow (circulation).
It is not known if REGRANEX is safe and effective in children under 16 years of age. Who should not use REGRANEX? Do not use REGRANEX if you have a cancer at the application site.
Before using REGRANEX, tell your healthcare provider about all of your medical conditions, including if you: have cancer. are pregnant or plan to become pregnant. It is not known if REGRANEX will harm your unborn baby. are breastfeeding or plan to breastfeed. It is not known if REGRANEX passes into your breast milk.
Talk to your healthcare provider about the best way to feed your baby during treatment with REGRANEX. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. How should I use REGRANEX?
Read the Instructions for Use for detailed information about the right way to apply REGRANEX. Use REGRANEX together with good ulcer care, as prescribed by your healthcare provider. This includes following your healthcare provider's instructions about not putting weight (non-weight bearing) on the affected leg and foot.
Use REGRANEX exactly as your healthcare provider tells you to use it. The amount of REGRANEX you will apply will depend on the size of your ulcer. Your healthcare provider should check the size of your ulcer every 1 to 2 weeks.
Your healthcare provider may change the amount of REGRANEX to be applied to your ulcer as the size of your ulcer changes. What are the possible side effects of REGRANEX? REGRANEX may cause serious side effects.
See "What is the most important information I should know about REGRANEX?" Application site reactions. Tell your healthcare provider if you have any skin reactions such as burning sensation at the site of application during treatment with REGRANEX. Your healthcare provider may temporarily stop or completely stop treatment with REGRANEX if you have skin reactions.
The most common side effect of REGRANEX is red skin rashes. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
You may also report side effects to Lynch Regenerative Medicine, LLC at 1-888-576-7343 How should I store REGRANEX? Store REGRANEX in the refrigerator at 36°F to 46°F (2°C to 8°C). Do not freeze REGRANEX.
Do not use REGRANEX after the expiration date on the bottom (sealed end) of the tube. Throw away your REGRANEX that is out of date or no longer needed for your treatment. Keep REGRANEX and all medicines out of the reach of children.
General information about the safe and effective use of REGRANEX Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use REGRANEX for a condition for which it was not prescribed. Do not give REGRANEX to other people, even if they have the same symptoms that you have.
It may harm them. You can ask your healthcare provider or pharmacist for information about REGRANEX that is written for health professionals. What are the ingredients in REGRANEX?
Active ingredient: becaplermin Inactive ingredients: carboxymethylcellulose sodium, acetic acid,…