MIPLYFFA
- Product NDC
- 72542-193
- 11-digit product format
- 725420193
- Labeler code
- 72542
- Product ID
- 72542-193_18850625-1a1d-4351-862e-5d46b08eb978
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- arimoclomol citrate
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Acer Therapeutics Inc.
- Application
- NDA214927
- Marketing category
- NDA
- Marketing start
- 2024-09-20
- Substance
- ARIMOCLOMOL CITRATE
- Active strength
- 93 mg/1
- Pharmacologic classes
- Organic Cation Transporter 2 Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- MIPLYFFA
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ARIMOCLOMOL CITRATE | 93 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | Q85FFY6179 |
| Rxcui | 2694288, 2694294, 2694296, 2694298, 2694300, 2694302, 2694304, 2694306 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| ee65f1ab-b196-42a5-b39d-16b01af4c0de | Product name | 1 | 20250401 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 72542-193-01 | MIPLYFFA | 90 in 1 BOTTLE | CAPSULE | 90 | 5 | |
| 72542-193-01 | MIPLYFFA | 1 in 1 CARTON | CAPSULE | 1 | 5 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 72542-193-01 | EA - Each | 72542-193 | f595fce7-e218-43dd-8bf3-97e8e0c2d634 | 1 | 2024-10-04 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2694288 | arimoclomol 124 MG Oral Capsule | PSN | 5feffc0e-453d-47fa-91dd-38d4952309bc | 5 |
| 2694296 | arimoclomol 47 MG Oral Capsule | PSN | 5feffc0e-453d-47fa-91dd-38d4952309bc | 5 |
| 2694300 | arimoclomol 62 MG Oral Capsule | PSN | 5feffc0e-453d-47fa-91dd-38d4952309bc | 5 |
| 2694304 | arimoclomol 93 MG Oral Capsule | PSN | 5feffc0e-453d-47fa-91dd-38d4952309bc | 5 |
| 2694294 | MIPLYFFA 124 MG Oral Capsule | PSN | 5feffc0e-453d-47fa-91dd-38d4952309bc | 5 |
| 2694298 | MIPLYFFA 47 MG Oral Capsule | PSN | 5feffc0e-453d-47fa-91dd-38d4952309bc | 5 |
| 2694302 | MIPLYFFA 62 MG Oral Capsule | PSN | 5feffc0e-453d-47fa-91dd-38d4952309bc | 5 |
| 2694306 | MIPLYFFA 93 MG Oral Capsule | PSN | 5feffc0e-453d-47fa-91dd-38d4952309bc | 5 |
| 2694294 | arimoclomol 124 MG Oral Capsule [Miplyffa] | SBD | 5feffc0e-453d-47fa-91dd-38d4952309bc | 5 |
| 2694298 | arimoclomol 47 MG Oral Capsule [Miplyffa] | SBD | 5feffc0e-453d-47fa-91dd-38d4952309bc | 5 |
| 2694302 | arimoclomol 62 MG Oral Capsule [Miplyffa] | SBD | 5feffc0e-453d-47fa-91dd-38d4952309bc | 5 |
| 2694306 | arimoclomol 93 MG Oral Capsule [Miplyffa] | SBD | 5feffc0e-453d-47fa-91dd-38d4952309bc | 5 |
| 2694288 | arimoclomol 124 MG Oral Capsule | SCD | 5feffc0e-453d-47fa-91dd-38d4952309bc | 5 |
| 2694296 | arimoclomol 47 MG Oral Capsule | SCD | 5feffc0e-453d-47fa-91dd-38d4952309bc | 5 |
| 2694300 | arimoclomol 62 MG Oral Capsule | SCD | 5feffc0e-453d-47fa-91dd-38d4952309bc | 5 |
| 2694304 | arimoclomol 93 MG Oral Capsule | SCD | 5feffc0e-453d-47fa-91dd-38d4952309bc | 5 |
| 2694288 | arimoclomol 124 MG (equivalent to 200 MG arimoclomol citrate) Oral Capsule | SY | 5feffc0e-453d-47fa-91dd-38d4952309bc | 5 |
| 2694296 | arimoclomol 47 MG (equivalent to 75 MG arimoclomol citrate) Oral Capsule | SY | 5feffc0e-453d-47fa-91dd-38d4952309bc | 5 |
| 2694300 | arimoclomol 62 MG (equivalent to 100 MG arimoclomol citrate) Oral Capsule | SY | 5feffc0e-453d-47fa-91dd-38d4952309bc | 5 |
| 2694304 | arimoclomol 93 MG (equivalent to 150 MG arimoclomol citrate) Oral Capsule | SY | 5feffc0e-453d-47fa-91dd-38d4952309bc | 5 |
| 2694294 | Miplyffa 124 MG (equivalent to 200 MG arimoclomol citrate) Oral Capsule | SY | 5feffc0e-453d-47fa-91dd-38d4952309bc | 5 |
| 2694298 | Miplyffa 47 MG (equivalent to 75 MG arimoclomol citrate) Oral Capsule | SY | 5feffc0e-453d-47fa-91dd-38d4952309bc | 5 |
| 2694302 | Miplyffa 62 MG (equivalent to 100 MG arimoclomol citrate) Oral Capsule | SY | 5feffc0e-453d-47fa-91dd-38d4952309bc | 5 |
| 2694306 | Miplyffa 93 MG (equivalent to 150 MG arimoclomol citrate) Oral Capsule | SY | 5feffc0e-453d-47fa-91dd-38d4952309bc | 5 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 72542-193-01 | 72542019301 | 1 BOTTLE in 1 CARTON (72542-193-01) / 90 CAPSULE in 1 BOTTLE | 1 bottle | 2024-09-20 | No | No | Historical |