NDC 62856-705
Salagen
Pilocarpine Hyrochloride
Salagen is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Eisai Inc.. The primary component is Pilocarpine Hydrochloride.
| Product ID | 62856-705_13490d5b-0ef4-495a-9ba9-dbb9e209593f |
| NDC | 62856-705 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Salagen |
| Generic Name | Pilocarpine Hyrochloride |
| Dosage Form | Tablet, Film Coated |
| Route of Administration | ORAL |
| Marketing Start Date | 1994-03-22 |
| Marketing End Date | 2023-07-31 |
| Marketing Category | NDA / NDA |
| Application Number | NDA020237 |
| Labeler Name | Eisai Inc. |
| Substance Name | PILOCARPINE HYDROCHLORIDE |
| Active Ingredient Strength | 5 mg/1 |
| Pharm Classes | Cholinergic Agonists [MoA],Cholinergic Muscarinic Agonists [MoA],Cholinergic Receptor Agonist [EPC] |
| NDC Exclude Flag | N |
Packaging
NDC 62856-705-10
100 TABLET, FILM COATED in 1 BOTTLE (62856-705-10)
| Marketing Start Date | 1994-03-22 |
| Marketing End Date | 2023-07-31 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 62856-705-30 [62856070530]
Salagen TABLET, FILM COATED
| Marketing Category | NDA |
| Application Number | NDA020237 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 1994-03-22 |
| Marketing End Date | 2018-10-31 |
NDC 62856-705-10 [62856070510]
Salagen TABLET, FILM COATED
| Marketing Category | NDA |
| Application Number | NDA020237 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 1994-03-22 |
| Marketing End Date | 2023-07-31 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| PILOCARPINE HYDROCHLORIDE | 5 mg/1 |
OpenFDA Data
| SPL SET ID: | fb4810ec-d26f-429d-b87c-5898a7870169 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
Pharmacological Class
- Cholinergic Agonists [MoA]
- Cholinergic Muscarinic Agonists [MoA]
- Cholinergic Receptor Agonist [EPC]
Medicade Reported Pricing
62856070510 SALAGEN 5 MG TABLET
Pricing Unit: EA | Drug Type:
NDC Crossover Matching brand name "Salagen" or generic name "Pilocarpine Hyrochloride"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 59212-705 | Salagen | Pilocarpine Hydrochloride |
| 59212-775 | Salagen | Pilocarpine Hydrochloride |
| 62856-705 | Salagen | pilocarpine hyrochloride |
| 62856-775 | Salagen | pilocarpine hyrochloride |
Trademark Results [Salagen]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SALAGEN 74120609 1753114 Live/Registered |
EISAI INC. 1990-12-04 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.