Loperamide hydrochloride and Simethicone
- Product NDC
- 69452-531
- 11-digit product format
- 694520531
- Labeler code
- 69452
- Product ID
- 69452-531_47a779be-990b-5c3b-e063-6394a90ac456
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- loperamide hydrochloride and simethicone
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bionpharma Inc.
- Application
- ANDA213484
- Marketing category
- ANDA
- Marketing start
- 2026-01-07
- 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
- 2027-12-31
- Current FDA listing
- Yes
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 69452-531-12 | Loperamide hydrochloride and Simethicone | 6 in 1 BLISTER PACK | TABLET | 6 | | 1 |
| 69452-531-12 | Loperamide hydrochloride and Simethicone | 4 in 1 CARTON | TABLET | 4 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 69452-531-12 | 69452053112 | 4 BLISTER PACK in 1 CARTON (69452-531-12) / 6 TABLET in 1 BLISTER PACK | 4 blister pack | 2026-01-07 | No | No | Historical |