Loperamide Hydrochloride
- Product NDC
- 70518-3413
- 11-digit product format
- 705183413
- Labeler code
- 70518
- Product ID
- 70518-3413_dd067771-b23f-322b-e053-2a95a90a2a6b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Loperamide Hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA215001
- Marketing category
- ANDA
- Marketing start
- 2022-04-17
- Marketing end
- 0000-00-00
- Substance
- LOPERAMIDE HYDROCHLORIDE
- Active strength
- 2 mg/1
- Pharmacologic classes
- Opioid Agonist [EPC], Opioid Agonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70518-3413 | LOPERAMIDE HYDROCHLORIDE CAPSULE [REMEDYREPACK INC.] | 5 | Legacy NDC | 20250327_71e6c12a-56bb-4655-ad0a-8ef3c3205249.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 70518-3413-0 | 70518341300 | 10 CAPSULE in 1 BLISTER PACK (70518-3413-0) | 10 capsule | 2022-04-17 | 0000-00-00 | No | No | Current |
| 70518-3413-1 | 70518341301 | 30 CAPSULE in 1 BLISTER PACK (70518-3413-1) | 30 capsule | 2022-04-19 | 0000-00-00 | No | No | Current |