Demser
- Product NDC
- 25010-305
- 11-digit product format
- 250100305
- Labeler code
- 25010
- Product ID
- 25010-305_7997d826-eb49-4688-9833-e668985c1e74
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- metyrosine
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Bausch Health US, LLC
- Application
- NDA017871
- Marketing category
- NDA
- Marketing start
- 1979-10-03
- Substance
- METYROSINE
- Active strength
- 250 mg/1
- Pharmacologic classes
- Catecholamine Synthesis Inhibitor [EPC], Catecholamine Synthesis Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Demser
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| METYROSINE | 250 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | DOQ0J0TPF7 |
| Rxcui | 197980, 201388 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 25010-305-15 | Demser | 100 in 1 BOTTLE | CAPSULE | 100 | | 10 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| metyrosine | ACTIVE INGREDIENT | DOQ0J0TPF7 | DEMSER (METYROSINE) CAPSULE [ATON PHARMA, INC.] | 3 | |
| metyrosine | ACTIVE MOIETY | DOQ0J0TPF7 | DEMSER (METYROSINE) CAPSULE [ATON PHARMA, INC.] | 3 | |
| FD&C Blue No. 2 | INACTIVE INGREDIENT | L06K8R7DQK | DEMSER (METYROSINE) CAPSULE [ATON PHARMA, INC.] | 3 | |
| gelatin | INACTIVE INGREDIENT | 2G86QN327L | DEMSER (METYROSINE) CAPSULE [ATON PHARMA, INC.] | 3 | |
| hydroxypropyl cellulose | INACTIVE INGREDIENT | RFW2ET671P | DEMSER (METYROSINE) CAPSULE [ATON PHARMA, INC.] | 3 | |
| magnesium stearate | INACTIVE INGREDIENT | 70097M6I30 | DEMSER (METYROSINE) CAPSULE [ATON PHARMA, INC.] | 3 | |
| silicon dioxide | INACTIVE INGREDIENT | ETJ7Z6XBU4 | DEMSER (METYROSINE) CAPSULE [ATON PHARMA, INC.] | 3 | |
| titanium dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | DEMSER (METYROSINE) CAPSULE [ATON PHARMA, INC.] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 25010-305 | DEMSER (METYROSINE) CAPSULE [BAUSCH HEALTH US, LLC] | 10 | Current NDC, Legacy NDC, 1 package rows | 20210915_32fb2f2f-34b5-4cd5-9145-c3ab37c5ca92.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 25010-305-15 | 25010030515 | 100 CAPSULE in 1 BOTTLE (25010-305-15) | 100 capsule | 1979-10-03 | 0000-00-00 | No | No | Current |