anti-diarrheal
- Product NDC
- 69452-176
- 11-digit product format
- 694520176
- Labeler code
- 69452
- Product ID
- 69452-176_a3d76812-4130-4578-a272-e165f67d9238
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- LOPERAMIDE HYDROCHLORIDE
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- Bionpharma Inc.
- Application
- NDA021855
- Marketing category
- NDA
- Marketing start
- 2019-08-02
- Substance
- LOPERAMIDE HYDROCHLORIDE
- Active strength
- 2 mg/1
- 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 | 2 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 77TI35393C |
| Rxcui | 978006 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 69452-176-12 | anti-diarrheal | 1 in 1 CARTON | CAPSULE, LIQUID FILLED | 1 | | 1 |
| 69452-176-12 | anti-diarrheal | 24 in 1 BLISTER PACK | CAPSULE, LIQUID FILLED | 24 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69452-176 | ANTI-DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [BIONPHARMA INC.] | 1 | Current NDC, Legacy NDC, 2 package rows | 20190913_8f1ee652-a4f7-4e5b-874f-46aa641cd43f.zip |
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 |
|---|
| 69452-176-12 | 69452017612 | 1 BLISTER PACK in 1 CARTON (69452-176-12) / 24 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | 1 blister pack | 2019-08-02 | 0000-00-00 | No | No | Current |