Loperamide Hydrochloride
- Product NDC
- 53329-664
- 11-digit product format
- 533290664
- Labeler code
- 53329
- Product ID
- 53329-664_2a761ab3-5c74-92c0-e063-6294a90a93aa
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Loperamide Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Medline Industries, LP
- Application
- ANDA074091
- Marketing category
- ANDA
- Marketing start
- 1993-02-01
- 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 | 978010 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 53329-664-57 | Loperamide Hydrochloride | 12 in 1 BLISTER PACK | TABLET | 12 | | 8 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| LOPERAMIDE HYDROCHLORIDE | ACTIVE INGREDIENT | 77TI35393C | LOPERAMIDE HYDROCHLORIDE TABLET [MEDLINE INDUSTRIES, INC.] | 1 | |
| LOPERAMIDE | ACTIVE MOIETY | 6X9OC3H4II | LOPERAMIDE HYDROCHLORIDE TABLET [MEDLINE INDUSTRIES, INC.] | 1 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | LOPERAMIDE HYDROCHLORIDE TABLET [MEDLINE INDUSTRIES, INC.] | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | LOPERAMIDE HYDROCHLORIDE TABLET [MEDLINE INDUSTRIES, INC.] | 1 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | LOPERAMIDE HYDROCHLORIDE TABLET [MEDLINE INDUSTRIES, INC.] | 1 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | LOPERAMIDE HYDROCHLORIDE TABLET [MEDLINE INDUSTRIES, INC.] | 1 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | LOPERAMIDE HYDROCHLORIDE TABLET [MEDLINE INDUSTRIES, INC.] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | LOPERAMIDE HYDROCHLORIDE TABLET [MEDLINE INDUSTRIES, INC.] | 1 | |
| POWDERED CELLULOSE | INACTIVE INGREDIENT | SMD1X3XO9M | LOPERAMIDE HYDROCHLORIDE TABLET [MEDLINE INDUSTRIES, INC.] | 1 | |
| STARCH, PREGELATINIZED CORN | INACTIVE INGREDIENT | O8232NY3SJ | LOPERAMIDE HYDROCHLORIDE TABLET [MEDLINE INDUSTRIES, INC.] | 1 | |
| TRISTEARIN | INACTIVE INGREDIENT | P6OCJ2551R | LOPERAMIDE HYDROCHLORIDE TABLET [MEDLINE INDUSTRIES, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53329-664 | LOPERAMIDE HYDROCHLORIDE TABLET [MEDLINE INDUSTRIES, LP] | 8 | Current NDC, Legacy NDC, 1 package rows | 20250101_03d68bcf-6413-4fe3-8263-39cc315452d2.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 |
|---|
| 53329-664-57 | 53329066457 | 12 TABLET in 1 BLISTER PACK (53329-664-57) | 12 tablet | 1993-02-01 | 0000-00-00 | No | No | Current |