AGAMREE
- Product NDC
- 69616-264
- 11-digit product format
- 696160264
- Labeler code
- 69616
- Product ID
- 69616-264_8e502b8a-7d2d-476b-8516-6678cfefbe32
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- VAMOROLONE
- Dosage form
- KIT
- Route
- ORAL
- Labeler
- Catalyst Pharmaceuticals, Inc.
- Application
- NDA215239
- Marketing category
- NDA
- Marketing start
- 2024-02-01
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- AGAMREE
- Listing expiration
- 2027-12-31
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Rxcui | 2669804, 2669810 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 69616-264-38 | AGAMREE | 1 in 1 CARTON | KIT | 1 | | 10 |
| 69616-265-38 | AGAMREE | 100 mL in 1 BOTTLE, GLASS | SUSPENSION | 100 mL | 40 mg in 1mL | 10 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69616-264 | AGAMREE (VAMOROLONE) KIT [CATALYST PHARMACEUTICALS, INC.] | 7 | Current NDC, 2 package rows | 20250413_fb376f09-cf9c-42b5-b4dd-02d5bcd73211.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 69616-264-38 | 69616026438 | 1 KIT in 1 CARTON (69616-264-38) * 100 mL in 1 BOTTLE, GLASS (69616-265-38) | 1 kit | 2024-02-01 | No | No | Current |
| 69616-265-38 | 69616026538 | 100 mL in 1 BOTTLE, GLASS | 100 ml | | | | Historical |