Loperamide Hydrochloride
- Product NDC
- 55289-315
- 11-digit product format
- 552890315
- Labeler code
- 55289
- Product ID
- 55289-315_4199e187-f646-693a-e063-6294a90ae583
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Loperamide Hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA073192
- Marketing category
- ANDA
- Marketing start
- 1993-05-01
- 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
- Loperamide Hydrochloride
- 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 |
|---|
| 55289-315-06 | Loperamide Hydrochloride | 6 in 1 BOTTLE, PLASTIC | CAPSULE | 6 | | 20 |
| 55289-315-08 | Loperamide Hydrochloride | 8 in 1 BOTTLE, PLASTIC | CAPSULE | 8 | | 20 |
| 55289-315-10 | Loperamide Hydrochloride | 10 in 1 BOTTLE, PLASTIC | CAPSULE | 10 | | 20 |
| 55289-315-12 | Loperamide Hydrochloride | 12 in 1 BOTTLE, PLASTIC | CAPSULE | 12 | | 20 |
| 55289-315-15 | Loperamide Hydrochloride | 15 in 1 BOTTLE, PLASTIC | CAPSULE | 15 | | 20 |
| 55289-315-20 | Loperamide Hydrochloride | 20 in 1 BOTTLE, PLASTIC | CAPSULE | 20 | | 20 |
| 55289-315-30 | Loperamide Hydrochloride | 30 in 1 BOTTLE, PLASTIC | CAPSULE | 30 | | 20 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| LOPERAMIDE HYDROCHLORIDE | ACTIVE INGREDIENT | 77TI35393C | LOPERAMIDE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.] | 5 | |
| LOPERAMIDE | ACTIVE MOIETY | 6X9OC3H4II | LOPERAMIDE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.] | 5 | |
| DIMETHICONE | INACTIVE INGREDIENT | 92RU3N3Y1O | LOPERAMIDE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.] | 5 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | LOPERAMIDE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.] | 5 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | LOPERAMIDE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.] | 5 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | LOPERAMIDE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.] | 5 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | LOPERAMIDE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.] | 5 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | LOPERAMIDE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.] | 5 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | LOPERAMIDE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.] | 5 | |
| SHELLAC | INACTIVE INGREDIENT | 46N107B71O | LOPERAMIDE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.] | 5 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | LOPERAMIDE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.] | 5 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | LOPERAMIDE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.] | 5 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55289-315 | LOPERAMIDE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.] | 19 | Current NDC, Legacy NDC, 7 package rows | 20241011_3310a3c2-389a-4b27-a478-67c905789854.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 |
|---|
| 55289-315-06 | 55289031506 | 6 CAPSULE in 1 BOTTLE, PLASTIC (55289-315-06) | 6 capsule | 2011-09-23 | 0000-00-00 | No | No | Current |
| 55289-315-08 | 55289031508 | 8 CAPSULE in 1 BOTTLE, PLASTIC (55289-315-08) | 8 capsule | 2011-09-23 | 0000-00-00 | No | No | Current |
| 55289-315-10 | 55289031510 | 10 CAPSULE in 1 BOTTLE, PLASTIC (55289-315-10) | 10 capsule | 2011-09-23 | 0000-00-00 | No | No | Current |
| 55289-315-12 | 55289031512 | 12 CAPSULE in 1 BOTTLE, PLASTIC (55289-315-12) | 12 capsule | 2011-09-23 | 0000-00-00 | No | No | Current |
| 55289-315-15 | 55289031515 | 15 CAPSULE in 1 BOTTLE, PLASTIC (55289-315-15) | 15 capsule | 2011-09-23 | 0000-00-00 | No | No | Current |
| 55289-315-20 | 55289031520 | 20 CAPSULE in 1 BOTTLE, PLASTIC (55289-315-20) | 20 capsule | 2011-09-23 | 0000-00-00 | No | No | Current |
| 55289-315-30 | 55289031530 | 30 CAPSULE in 1 BOTTLE, PLASTIC (55289-315-30) | 30 capsule | 2011-09-23 | 0000-00-00 | No | No | Current |