Loperamide Hydrochloride
- Product NDC
- 68094-029
- 11-digit product format
- 680940029
- Labeler code
- 68094
- Product ID
- 68094-029_73a0214b-3f58-4357-ab53-314111602166
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Loperamide Hydrochloride
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Precision Dose, Inc.
- Application
- ANDA091292
- Marketing category
- ANDA
- Marketing start
- 2020-05-18
- Substance
- LOPERAMIDE HYDROCHLORIDE
- Active strength
- 1 mg/7.5mL
- Pharmacologic classes
- Opioid Agonist [EPC], Opioid Agonists [MoA]
- 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
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LOPERAMIDE HYDROCHLORIDE | 1 mg/7.5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 77TI35393C |
| Rxcui | 1250685 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68094-029-59 | Loperamide Hydrochloride | 7.5 mL in 1 CUP, UNIT-DOSE | SOLUTION | 7.5 | | 4 |
| 68094-029-62 | Loperamide Hydrochloride | 3 in 1 CASE | SOLUTION | 3 | | 4 |
| 68094-029-62 | Loperamide Hydrochloride | 10 in 1 TRAY | SOLUTION | 10 | | 4 |
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 |
|---|
| 68094-029-59 | 68094002959 | 7.5 mL in 1 CUP, UNIT-DOSE | 7.5 ml | | | | | Historical |
| 68094-029-62 | 68094002962 | 3 TRAY in 1 CASE (68094-029-62) / 10 CUP, UNIT-DOSE in 1 TRAY / 7.5 mL in 1 CUP, UNIT-DOSE (68094-029-59) | 3 tray | 2020-05-18 | 0000-00-00 | No | No | Current |