Loperamide Hydrochloride
- Product NDC
- 70518-3400
- 11-digit product format
- 705183400
- Labeler code
- 70518
- Product ID
- 70518-3400_eedb03c8-3689-5824-e053-2995a90ac55e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- loperamide hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA215579
- Marketing category
- ANDA
- Marketing start
- 2022-04-04
- 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 |
|---|
| 70518-3400 | LOPERAMIDE HYDROCHLORIDE CAPSULE [REMEDYREPACK INC.] | 6 | Legacy NDC | 20240927_e3d3f75a-272b-4c85-804f-b04544ae90e7.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 70518-3400-0 | 70518340000 | 30 CAPSULE in 1 BLISTER PACK (70518-3400-0) | 30 capsule | 2022-04-04 | 0000-00-00 | No | No | Current |
| 70518-3400-1 | 70518340001 | 10 CAPSULE in 1 BLISTER PACK (70518-3400-1) | 10 capsule | 2022-05-02 | 0000-00-00 | No | No | Current |