Loperamide hydrochloride and Simethicone
- Product NDC
- 69452-210
- 11-digit product format
- 694520210
- Labeler code
- 69452
- Product ID
- 69452-210_45c4a3fe-23d5-2584-e063-6394a90a1be7
- 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
- 2021-12-01
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Loperamide hydrochloride and Simethicone
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DIMETHICONE | 125 mg/1 |
| LOPERAMIDE HYDROCHLORIDE | 2 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 92RU3N3Y1O, 77TI35393C |
| Rxcui | 978001 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 69452-210-04 | Loperamide hydrochloride and Simethicone | 1 in 1 CARTON | TABLET | 1 | | 3 |
| 69452-210-04 | Loperamide hydrochloride and Simethicone | 6 in 1 BLISTER PACK | TABLET | 6 | | 3 |
| 69452-210-12 | Loperamide hydrochloride and Simethicone | 6 in 1 BLISTER PACK | TABLET | 6 | | 3 |
| 69452-210-12 | Loperamide hydrochloride and Simethicone | 4 in 1 CARTON | TABLET | 4 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69452-210 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE TABLET [BIONPHARMA INC.] | 2 | Current NDC, Legacy NDC, 4 package rows | 20211201_9b0a802f-6fae-4142-ad2f-4b16ed67400e.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 |
|---|
| 69452-210-04 | 69452021004 | 1 BLISTER PACK in 1 CARTON (69452-210-04) / 6 TABLET in 1 BLISTER PACK | 1 blister pack | 2021-12-19 | 0000-00-00 | No | No | Current |
| 69452-210-12 | 69452021012 | 4 BLISTER PACK in 1 CARTON (69452-210-12) / 6 TABLET in 1 BLISTER PACK | 4 blister pack | 2021-12-19 | 0000-00-00 | No | No | Current |