Loperamide Hydrochloride
- Product NDC
- 71335-1921
- 11-digit product format
- 713351921
- Labeler code
- 71335
- Product ID
- 71335-1921_fc76e96e-9ce8-de0f-e053-6294a90a0eb2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- loperamide hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA072741
- Marketing category
- ANDA
- Marketing start
- 1991-09-18
- 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 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 71335-1921-0 | 71335192100 | 50 CAPSULE in 1 BOTTLE, PLASTIC (71335-1921-0) | 50 capsule | 2022-05-03 | 0000-00-00 | No | No | Current |
| 71335-1921-1 | 71335192101 | 15 CAPSULE in 1 BOTTLE, PLASTIC (71335-1921-1) | 15 capsule | 2021-07-30 | 0000-00-00 | No | No | Current |
| 71335-1921-2 | 71335192102 | 30 CAPSULE in 1 BOTTLE, PLASTIC (71335-1921-2) | 30 capsule | 2021-08-30 | 0000-00-00 | No | No | Current |
| 71335-1921-3 | 71335192103 | 20 CAPSULE in 1 BOTTLE, PLASTIC (71335-1921-3) | 20 capsule | 2021-08-18 | 0000-00-00 | No | No | Current |
| 71335-1921-4 | 71335192104 | 12 CAPSULE in 1 BOTTLE, PLASTIC (71335-1921-4) | 12 capsule | 2021-08-20 | 0000-00-00 | No | No | Current |
| 71335-1921-5 | 71335192105 | 60 CAPSULE in 1 BOTTLE, PLASTIC (71335-1921-5) | 60 capsule | 2022-05-03 | 0000-00-00 | No | No | Current |
| 71335-1921-6 | 71335192106 | 24 CAPSULE in 1 BOTTLE, PLASTIC (71335-1921-6) | 24 capsule | 2021-07-30 | 0000-00-00 | No | No | Current |
| 71335-1921-7 | 71335192107 | 14 CAPSULE in 1 BOTTLE, PLASTIC (71335-1921-7) | 14 capsule | 2022-05-03 | 0000-00-00 | No | No | Current |
| 71335-1921-8 | 71335192108 | 9 CAPSULE in 1 BOTTLE, PLASTIC (71335-1921-8) | 9 capsule | 2021-07-26 | 0000-00-00 | No | No | Current |
| 71335-1921-9 | 71335192109 | 5 CAPSULE in 1 BOTTLE, PLASTIC (71335-1921-9) | 5 capsule | 2022-02-23 | 0000-00-00 | No | No | Current |