Anti-diarrheal
- Product NDC
- 68016-301
- 11-digit product format
- 680160301
- Labeler code
- 68016
- Product ID
- 68016-301_f05ff0cc-d7bd-45a9-8612-f20870c9668c
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Loperamide HCl
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Chain Drug Consortium
- Application
- ANDA076497
- Marketing category
- ANDA
- Marketing start
- 2019-12-06
- Marketing end
- 2026-11-30
- Substance
- LOPERAMIDE HYDROCHLORIDE
- Active strength
- 2 mg/1
- Pharmacologic classes
- Opioid Agonist [EPC], Opioid Agonists [MoA]
- NDC exclude flag
- No
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Anti-diarrheal
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#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68016-301-06 | Anti-diarrheal | 1 in 1 CARTON | TABLET | 1 | | 7 |
| 68016-301-06 | Anti-diarrheal | 6 in 1 BLISTER PACK | TABLET | 6 | | 7 |
| 68016-301-18 | Anti-diarrheal | 6 in 1 BLISTER PACK | TABLET | 6 | | 7 |
| 68016-301-18 | Anti-diarrheal | 3 in 1 CARTON | TABLET | 3 | | 7 |
| 68016-301-24 | Anti-diarrheal | 6 in 1 BLISTER PACK | TABLET | 6 | | 7 |
| 68016-301-24 | Anti-diarrheal | 4 in 1 CARTON | TABLET | 4 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68016-301 | ANTI-DIARRHEAL (LOPERAMIDE HCL) TABLET [CHAIN DRUG CONSORTIUM] | 6 | Current NDC, Legacy NDC, 6 package rows | 20241206_1b82f4ce-0cf5-46d1-9894-9f1271b29569.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 |
|---|
| 68016-301-06 | 68016030106 | 1 BLISTER PACK in 1 CARTON (68016-301-06) > 6 TABLET in 1 BLISTER PACK | 1 blister pack | 2019-12-06 | 0000-00-00 | No | No | Current |
| 68016-301-18 | 68016030118 | 3 BLISTER PACK in 1 CARTON (68016-301-18) / 6 TABLET in 1 BLISTER PACK | 3 blister pack | 2019-12-06 | 2026-11-30 | No | No | Current |
| 68016-301-24 | 68016030124 | 4 BLISTER PACK in 1 CARTON (68016-301-24) / 6 TABLET in 1 BLISTER PACK | 4 blister pack | 2019-12-06 | 2026-11-30 | No | No | Current |