Loperamide Hydrochloride, Simethicone
- Product NDC
- 53041-263
- 11-digit product format
- 530410263
- Labeler code
- 53041
- Product ID
- 53041-263_289e6064-8eb8-4b56-bc9e-ee82ad83674f
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Loperamide Hydrochloride, Simethicone
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Guardian Drug Company
- Application
- ANDA214541
- Marketing category
- ANDA
- Marketing start
- 2021-06-01
- 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, 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 |
|---|
| 53041-263-50 | Loperamide Hydrochloride, Simethicone | 1 in 1 CARTON | TABLET | 1 | | 2 |
| 53041-263-50 | Loperamide Hydrochloride, Simethicone | 6 in 1 BLISTER PACK | TABLET | 6 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53041-263 | LOPERAMIDE HYDROCHLORIDE, SIMETHICONE TABLET [GUARDIAN DRUG COMPANY] | 2 | Current NDC, Legacy NDC, 2 package rows | 20210602_1b79204e-8a99-455b-84d6-f381fd7d1135.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 |
|---|
| 53041-263-50 | 53041026350 | 1 BLISTER PACK in 1 CARTON (53041-263-50) / 6 TABLET in 1 BLISTER PACK | 1 blister pack | 2021-06-01 | 0000-00-00 | No | No | Current |