anti diarrheal
- Product NDC
- 0904-7725
- 11-digit product format
- 009047725
- Labeler code
- 0904
- Product ID
- 0904-7725_6fd0ad94-87fe-4333-966b-ea405406344f
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Loperamide Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- Application
- ANDA075232
- Marketing category
- ANDA
- Marketing start
- 2003-02-24
- 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 | 978010 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0904-7725-12 | anti diarrheal | 1 in 1 BLISTER PACK | TABLET, FILM COATED | 1 | | 6 |
| 0904-7725-12 | anti diarrheal | 12 in 1 CARTON | TABLET, FILM COATED | 12 | | 6 |
| 0904-7725-24 | anti diarrheal | 24 in 1 CARTON | TABLET, FILM COATED | 24 | | 6 |
| 0904-7725-24 | anti diarrheal | 1 in 1 BLISTER PACK | TABLET, FILM COATED | 1 | | 6 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| LOPERAMIDE HYDROCHLORIDE | ACTIVE INGREDIENT | 77TI35393C | ANTI DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) TABLET, FILM COATED [MAJOR PHARMACEUTICALS] | 2 | |
| LOPERAMIDE | ACTIVE MOIETY | 6X9OC3H4II | ANTI DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) TABLET, FILM COATED [MAJOR PHARMACEUTICALS] | 2 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | ANTI DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) TABLET, FILM COATED [MAJOR PHARMACEUTICALS] | 2 | |
| CARNAUBA WAX | INACTIVE INGREDIENT | R12CBM0EIZ | ANTI DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) TABLET, FILM COATED [MAJOR PHARMACEUTICALS] | 2 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | ANTI DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) TABLET, FILM COATED [MAJOR PHARMACEUTICALS] | 2 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | ANTI DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) TABLET, FILM COATED [MAJOR PHARMACEUTICALS] | 2 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | ANTI DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) TABLET, FILM COATED [MAJOR PHARMACEUTICALS] | 2 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | ANTI DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) TABLET, FILM COATED [MAJOR PHARMACEUTICALS] | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | ANTI DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) TABLET, FILM COATED [MAJOR PHARMACEUTICALS] | 2 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | ANTI DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) TABLET, FILM COATED [MAJOR PHARMACEUTICALS] | 2 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | ANTI DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) TABLET, FILM COATED [MAJOR PHARMACEUTICALS] | 2 | |
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 |
|---|
| 0904-7725-12 | 00904772512 | 12 BLISTER PACK in 1 CARTON (0904-7725-12) / 1 TABLET, FILM COATED in 1 BLISTER PACK | 12 blister pack | 2003-02-24 | 0000-00-00 | No | No | Current |
| 0904-7725-24 | 00904772524 | 24 BLISTER PACK in 1 CARTON (0904-7725-24) / 1 TABLET, FILM COATED in 1 BLISTER PACK | 24 blister pack | 2003-02-24 | 0000-00-00 | No | No | Current |