Loperamide Hydrochloride and Simethicone
- Product NDC
- 62207-739
- 11-digit product format
- 622070739
- Labeler code
- 62207
- Product ID
- 62207-739_44e3c6ff-dda8-ee9e-e063-6394a90a03bb
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Loperamide Hydrochloride and Simethicone
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Granules India Ltd
- Application
- ANDA215981
- Marketing category
- ANDA
- Marketing start
- 2023-03-01
- 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 |
|---|
| 62207-739-69 | Loperamide Hydrochloride and Simethicone | 2 in 1 CARTON | TABLET | 2 | | 3 |
| 62207-739-69 | Loperamide Hydrochloride and Simethicone | 6 in 1 BLISTER PACK | TABLET | 6 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 62207-739 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE TABLET [GRANULES INDIA LTD] | 2 | Current NDC, 2 package rows | 20230301_e0c1693e-0e55-4368-a8a5-2f0882fbf952.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 62207-739-69 | 62207073969 | 2 BLISTER PACK in 1 CARTON (62207-739-69) / 6 TABLET in 1 BLISTER PACK | 2 blister pack | 2023-03-01 | No | No | Current |