Anti-Diarrheal
- Product NDC
- 84441-711
- 11-digit product format
- 844410711
- Labeler code
- 84441
- Product ID
- 84441-711_50058363-6837-309b-e063-6394a90aa07e
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Loperamide Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- IMO-GEN LABS LLC
- Application
- ANDA076497
- Marketing category
- ANDA
- Marketing start
- 2024-01-01
- Substance
- LOPERAMIDE HYDROCHLORIDE
- Active strength
- 2 mg/1
- Pharmacologic classes
- Opioid Agonist [EPC], Opioid Agonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Anti-Diarrheal
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LOPERAMIDE HYDROCHLORIDE | 2 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 77TI35393C |
| Rxcui | 978010 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 84441-711-02 | Anti-Diarrheal | 200 in 1 BOTTLE | TABLET | 200 | | 3 |
| 84441-711-25 | Anti-Diarrheal | 250 in 1 BOTTLE | TABLET | 250 | | 3 |
| 84441-711-96 | Anti-Diarrheal | 96 in 1 BOTTLE | TABLET | 96 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 84441-711 | ANTI-DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) TABLET [IMO-GEN LABS LLC] | 1 | Current NDC, 3 package rows | 20240622_1b5f2c7c-baf0-b213-e063-6394a90a25df.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 |
|---|
| 84441-711-02 | 84441071102 | 200 TABLET in 1 BOTTLE (84441-711-02) | 200 tablet | 2024-01-01 | No | No | Historical |
| 84441-711-25 | 84441071125 | 250 TABLET in 1 BOTTLE (84441-711-25) | 250 tablet | 2026-02-04 | No | No | Historical |
| 84441-711-96 | 84441071196 | 96 TABLET in 1 BOTTLE (84441-711-96) | 96 tablet | 2024-01-01 | No | No | Historical |