Prescription drug · BLA
Regranex Gel 0.01% (Becaplermin gel 0.01%) NDC 85822-734
Becaplermin .1 mg/g · Gel · Topical · LRM Therapeutics, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 85822-734-15 | 85822073415 | 15 g in 1 TUBE (85822-734-15)Marketed from Jun 30, 2025 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Regranex Gel 0.01%
- Generic name (nonproprietary)
- becaplermin gel 0.01%
- Active ingredients
- Becaplermin — .1 mg/g
- Dosage form
- Gel
- Route
- Topical
- Labeler
- LRM Therapeutics, LLCNDC labeler code 85822
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 103691
- Marketing start
- Listing expires
- Other FDA classes
- Platelet-Derived Growth Factor (Chemical structure)
- Identifiers
- Product ID 85822-734_a76b93e5-1b94-4a52-8efc-52c09c797ed6SPL ID a76b93e5-1b94-4a52-8efc-52c09c797ed6SPL set ID 377b3021-13d7-96d5-e063-6394a90a8ca3RxCUI 213197, 308579UNII 1B56C968OA
- Pharmacologic class
- Human Platelet-derived Growth Factor
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Topical products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N485822073415followed by a unit qualifier and the quantityPackage 85822-0734-15. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
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 …
Excerpt only. Read the full label for complete information.
About NDC 85822-734
- What is NDC 85822-734?
- 85822-734 is the product NDC for Regranex Gel 0.01% (becaplermin gel 0.01%), Becaplermin .1 mg/g gel, listed with the FDA by LRM Therapeutics, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Regranex Gel 0.01% (Becaplermin gel 0.01%).
- What is the active ingredient?
- Becaplermin.
- Who is the labeler?
- LRM Therapeutics, LLC, NDC labeler code 85822. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Regranex Gel 0.01%?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.