anti-diarrheal
- Product NDC
- 21130-381
- 11-digit product format
- 211300381
- Labeler code
- 21130
- Product ID
- 21130-381_2e3c126a-ec4b-4f79-9842-8a3976c572be
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- loperamide hydrochloride
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Safeway
- Application
- ANDA091292
- Marketing category
- ANDA
- Marketing start
- 2024-10-15
- 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
- anti-diarrheal
- 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 |
|---|
| 21130-381-34 | anti-diarrheal | 240 mL in 1 BOTTLE | SOLUTION | 240 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 21130-381 | ANTI-DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) SOLUTION [SAFEWAY] | 2 | Current NDC, 1 package rows | 20241025_9d0c565f-64a2-4300-b1e2-5dee9546ea14.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 |
|---|
| 21130-381-34 | 21130038134 | 240 mL in 1 BOTTLE (21130-381-34) | 240 ml | 2024-10-15 | No | No | Current |