Anti-Diarrheal
- Product NDC
- 41226-797
- 11-digit product format
- 412260797
- Labeler code
- 41226
- Product ID
- 41226-797_5a2a774a-a0fe-cf2c-e063-6294a90a29fa
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Loperamide Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Kroger
- Application
- ANDA220153
- Marketing category
- ANDA
- Marketing start
- 2026-09-18
- Substance
- LOPERAMIDE HYDROCHLORIDE
- Active strength
- 2 mg/1
- Pharmacologic classes
- Opioid Agonist [EPC], Opioid Agonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A220153-001 | LOPERAMIDE HYDROCHLORIDE | LOPERAMIDE HYDROCHLORIDE | 2MG | TABLET / ORAL | 2025-11-17 |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A220153-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | TABLET / ORAL | 2025-11-17 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A220153-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | TABLET / ORAL | 2025-11-17 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A220153-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | TABLET / ORAL | 2025-11-17 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A220153-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | TABLET / ORAL | 2025-11-17 | 31067a03dcf5… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A220153-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | TABLET / ORAL | 2025-11-17 | a50c72e98297… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Anti-Diarrheal
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| LOPERAMIDE HYDROCHLORIDE | 2 mg/1 |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Loperamide Hydrochloride 2mg | LOPERAMIDE HYDROCHLORIDE TABLETS USP, 2MG | MARKSANS PHARMA LIMITED | 644fb37a-1d97-4333-a5c7-5a485ab338f7 | 2025-11-19 | Warnings | 220153 ANDA220153 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 41226-797-22 | 41226079722 | 2 BLISTER PACK in 1 CARTON (41226-797-22) / 6 TABLET, FILM COATED in 1 BLISTER PACK | 2 blister pack | 2026-09-18 | No | No | Current |
| 41226-797-24 | 41226079724 | 4 BLISTER PACK in 1 CARTON (41226-797-24) / 6 TABLET, FILM COATED in 1 BLISTER PACK | 4 blister pack | 2026-09-18 | No | No | Current |