Loperamide Hydrochloride and Simethicone
- Product NDC
- 21130-222
- 11-digit product format
- 211300222
- Labeler code
- 21130
- Product ID
- 21130-222_d9e5ddb4-1b09-440f-82af-b3dd59ef3ec0
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Loperamide Hydrochloride and Simethicone
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Better Living Brands, LLC
- Application
- ANDA211059
- Marketing category
- ANDA
- Marketing start
- 2023-07-21
- Substance
- DIMETHICONE; LOPERAMIDE HYDROCHLORIDE
- Active strength
- 125; 2 mg/1; mg/1
- Pharmacologic classes
- Opioid Agonist [EPC], Opioid Agonists [MoA], Skin Barrier Activity [PE]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 92RU3N3Y1O | DIMETHICONE | 9006-65-9 | DIMETHICONE |
| 77TI35393C | LOPERAMIDE HYDROCHLORIDE | 34552-83-5 | LOPERAMIDE HYDROCHLORIDE |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 21130-222-24 | 21130022224 | 4 BLISTER PACK in 1 CARTON (21130-222-24) / 6 TABLET in 1 BLISTER PACK | 4 blister pack | 2023-07-21 | No | No | Historical |
| 21130-222-76 | 21130022276 | 3 BLISTER PACK in 1 CARTON (21130-222-76) / 6 TABLET in 1 BLISTER PACK | 3 blister pack | 2023-07-21 | No | No | Historical |