Home NDC 59779-960 anti diarrheal
Product NDC 59779-960
11-digit product format 597790960
Labeler code 59779
Product ID 59779-960_07f3d9cb-4c44-40fd-b85f-c0ed6b02471f
Type HUMAN OTC DRUG
Nonproprietary name Loperamide HCl
Dosage form TABLET, FILM COATED
Route ORAL
Labeler CVS Pharmacy
Application ANDA075232
Marketing category ANDA
Marketing start 2003-04-21
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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A075232-001 LOPERAMIDE HYDROCHLORIDE LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06
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.
Product history page 1 of 2 · 43 observed states.
Captured, Edition, Application-product table 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 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 84e616aacf4f…2026-08-18 06:07:40 2026-07 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 f41ea6bd6efb…
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 table Ingredient Strength LOPERAMIDE HYDROCHLORIDE 2 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 77TI35393C Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 978010 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 59779-960-62 anti diarrheal 1 in 1 BLISTER PACK TABLET, FILM COATED 1 5 59779-960-62 anti diarrheal 24 in 1 CARTON TABLET, FILM COATED 24 5
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded LOPERAMIDE HYDROCHLORIDE ACTIVE INGREDIENT 77TI35393C ANTI DIARRHEAL (LOPERAMIDE HCL) TABLET, FILM COATED [CVS PHARMACY] 1 LOPERAMIDE ACTIVE MOIETY 6X9OC3H4II ANTI DIARRHEAL (LOPERAMIDE HCL) TABLET, FILM COATED [CVS PHARMACY] 1 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK ANTI DIARRHEAL (LOPERAMIDE HCL) TABLET, FILM COATED [CVS PHARMACY] 1 CARNAUBA WAX INACTIVE INGREDIENT R12CBM0EIZ ANTI DIARRHEAL (LOPERAMIDE HCL) TABLET, FILM COATED [CVS PHARMACY] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ANTI DIARRHEAL (LOPERAMIDE HCL) TABLET, FILM COATED [CVS PHARMACY] 1 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G ANTI DIARRHEAL (LOPERAMIDE HCL) TABLET, FILM COATED [CVS PHARMACY] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD ANTI DIARRHEAL (LOPERAMIDE HCL) TABLET, FILM COATED [CVS PHARMACY] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO ANTI DIARRHEAL (LOPERAMIDE HCL) TABLET, FILM COATED [CVS PHARMACY] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ANTI DIARRHEAL (LOPERAMIDE HCL) TABLET, FILM COATED [CVS PHARMACY] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A ANTI DIARRHEAL (LOPERAMIDE HCL) TABLET, FILM COATED [CVS PHARMACY] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59779-960 ANTI DIARRHEAL (LOPERAMIDE HCL) TABLET, FILM COATED [CVS PHARMACY] 5 Current NDC, Legacy NDC, 2 package rows 20221027_68467222-c8b4-4029-a180-59a57d0090d3.zip
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.
Matched openFDA labels page 1 of 2 · 25 matching rows.
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 59779-960-62 59779096062 24 BLISTER PACK in 1 CARTON (59779-960-62) / 1 TABLET, FILM COATED in 1 BLISTER PACK 24 blister pack 2003-04-21 0000-00-00 No No Current