GLEOLAN
- Product NDC
- 59137-231
- 11-digit product format
- 591370231
- Labeler code
- 59137
- Product ID
- 59137-231_425c0da5-cec7-4a38-88ee-b230c0601f51
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- AMINOLEVULINIC ACID HYDROCHLORIDE
- Dosage form
- POWDER, FOR SOLUTION
- Route
- ORAL
- Labeler
- Medexus Pharma, Inc.
- Application
- NDA208630
- Marketing category
- NDA
- Marketing start
- 2018-04-14
- Substance
- AMINOLEVULINIC ACID HYDROCHLORIDE
- Active strength
- 1500 mg/1
- Pharmacologic classes
- Fluorescence Contrast Activity [MoA], Optical Imaging Agent [EPC], Porphyrin Precursor [EPC], Porphyrinogens [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- GLEOLAN
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| AMINOLEVULINIC ACID HYDROCHLORIDE | 1500 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | V35KBM8JGR |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 59137-231-01 | GLEOLAN | 1 in 1 VIAL, SINGLE-DOSE | POWDER, FOR SOLUTION | 1 | | 3 |
| 59137-231-01 | GLEOLAN | 1 in 1 CARTON | POWDER, FOR SOLUTION | 1 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 59137-231 | GLEOLAN (AMINOLEVULINIC ACID HYDROCHLORIDE) POWDER, FOR SOLUTION [MEDEXUS PHARMA, INC.] | 3 | Current NDC, Legacy NDC, 2 package rows | 20240507_4873911e-a5d7-47e3-9679-fa5c95999323.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 59137-231-01 | 59137023101 | 1 VIAL, SINGLE-DOSE in 1 CARTON (59137-231-01) / 1 POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE | 2022-03-01 | 0000-00-00 | No | No | Current |