Last updated: April 27, 2026
Who Supplies METROGEL-VAGINAL (Metronidazole vaginal gel) in the US?
What is METROGEL-VAGINAL?
METROGEL-VAGINAL is a brand of metronidazole vaginal gel used for treatment of bacterial vaginosis. The product is marketed under Endo Pharmaceuticals Inc. (brand owner for the US listed product).
Drug substance: metronidazole
Dosage form: vaginal gel (topical intravaginal use)
Source: FDA Orange Book listing for METROGEL-VAGINAL (active ingredient: metronidazole) [1].
Who supplies it (brand owner and manufacturing/labeler details)?
Which company is listed for METROGEL-VAGINAL in the FDA record?
FDA’s Orange Book lists Endo Pharmaceuticals Inc. as the company responsible for the branded product METROGEL-VAGINAL [1].
How are suppliers typically represented in the Orange Book record?
For branded products, the Orange Book entry commonly reflects:
- Applicant/labeler/holder (brand owner, responsible entity for the approved application)
Orange Book does not reliably expose the full third-party supply chain (API maker, contract manufacturer, fill-finish site) in a single public field for all products. The supplier data that is consistently available in public regulatory listings is the applicant/labeler record [1].
METROGEL-VAGINAL supplier profile (publicly listed)
| Role in supply chain |
Entity listed publicly |
Evidence |
| Brand owner / applicant (labeler) |
Endo Pharmaceuticals Inc. |
FDA Orange Book listing for METROGEL-VAGINAL [1] |
Is there any publicly listed “generic equivalent supplier” you can rely on?
What about ANDAs (generic versions) of metronidazole vaginal gel?
The FDA Orange Book contains entries for approved versions of metronidazole vaginal gel. However, “generic supplier” depends on the specific ANDA and labeler for each product, and Orange Book entries must be evaluated product-by-product to identify labeler(s) and application holders [1].
The only supplier name that is directly and consistently supported from the METROGEL-VAGINAL brand listing itself is the applicant/labeler: Endo Pharmaceuticals Inc. [1].
Key takeaways
- Endo Pharmaceuticals Inc. is the publicly listed applicant/labeler for METROGEL-VAGINAL in the FDA Orange Book.
- Public regulatory listings provide the most dependable “supplier” identification at the applicant/labeler level; the API and contract manufacturing network is not fully enumerated in a single consolidated public field for this product.
FAQs
1) Who is the labeler/applicant for METROGEL-VAGINAL?
Endo Pharmaceuticals Inc. [1]
2) What active ingredient is in METROGEL-VAGINAL?
Metronidazole (vaginal gel) [1]
3) What regulatory database is used to identify the supplier/labeler?
The FDA Orange Book entry for METROGEL-VAGINAL [1]
4) Does the Orange Book listing identify API and contract manufacturing sites?
Not in a single, consistently reliable public field for all branded products; it is primarily the applicant/labeler that is directly supported in the public listing [1].
5) Are there multiple suppliers if you consider generics?
Yes, if you include ANDA-labeled metronidazole vaginal gel products, each ANDA can have different labelers/applicants. That requires checking each product’s Orange Book entry individually [1].
References
[1] FDA. (n.d.). FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. Orange Book listing for METROGEL-VAGINAL (metronidazole vaginal gel). https://www.accessdata.fda.gov/scripts/cder/daf/ (search “METROGEL-VAGINAL” and open the Orange Book record).
