Diethylpropion Hydrochloride
- Product NDC
- 81665-109
- 11-digit product format
- 816650109
- Labeler code
- 81665
- Product ID
- 81665-109_487a8d77-bdc6-4b86-8494-2aa87e9c1175
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Diethylpropion Hydrochloride
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- OMNIVIUM PHARMACEUTICALS LLC.
- Application
- ANDA091680
- Marketing category
- ANDA
- Marketing start
- 2025-09-19
- Substance
- DIETHYLPROPION HYDROCHLORIDE
- Active strength
- 75 mg/1
- Pharmacologic classes
- Appetite Suppression [PE], Increased Sympathetic Activity [PE], Sympathomimetic Amine Anorectic [EPC]
- DEA schedule
- CIV
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Diethylpropion Hydrochloride
- Brand name suffix
- ER
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DIETHYLPROPION HYDROCHLORIDE | 75 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 19V2PL39NG |
| Rxcui | 978668 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 81665-109-10 | Diethylpropion HydrochlorideER | 100 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 100 | | 1 |
| 81665-109-25 | Diethylpropion HydrochlorideER | 250 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 250 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 81665-109-10 | 81665010910 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (81665-109-10) | 2025-09-19 | No | No | Historical |
| 81665-109-25 | 81665010925 | 250 TABLET, EXTENDED RELEASE in 1 BOTTLE (81665-109-25) | 2025-09-19 | No | No | Historical |