Home Applications 074352 Application 074352
Type ANDA
Sponsor HI TECH PHARMA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 LOPERAMIDE HYDROCHLORIDE LOPERAMIDE HYDROCHLORIDE SOLUTION;ORAL 1MG/5ML No No
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 A074352-001 LOPERAMIDE HYDROCHLORIDE LOPERAMIDE HYDROCHLORIDE 1MG/5ML SOLUTION / ORAL 1995-11-17
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.
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 A074352-001 LOPERAMIDE HYDROCHLORIDE 1MG/5ML SOLUTION / ORAL 1995-11-17 84e616aacf4f…2026-08-18 06:07:40 2026-07 A074352-001 LOPERAMIDE HYDROCHLORIDE 1MG/5ML SOLUTION / ORAL 1995-11-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A074352-001 LOPERAMIDE HYDROCHLORIDE 1MG/5ML SOLUTION / ORAL 1995-11-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074352-001 LOPERAMIDE HYDROCHLORIDE 1MG/5ML SOLUTION / ORAL 1995-11-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074352-001 LOPERAMIDE HYDROCHLORIDE 1MG/5ML SOLUTION / ORAL 1995-11-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074352-001 LOPERAMIDE HYDROCHLORIDE 1MG/5ML SOLUTION / ORAL 1995-11-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074352-001 LOPERAMIDE HYDROCHLORIDE 1MG/5ML SOLUTION / ORAL 1995-11-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074352-001 LOPERAMIDE HYDROCHLORIDE 1MG/5ML SOLUTION / ORAL 1995-11-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074352-001 LOPERAMIDE HYDROCHLORIDE 1MG/5ML SOLUTION / ORAL 1995-11-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074352-001 LOPERAMIDE HYDROCHLORIDE 1MG/5ML SOLUTION / ORAL 1995-11-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074352-001 LOPERAMIDE HYDROCHLORIDE 1MG/5ML SOLUTION / ORAL 1995-11-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074352-001 LOPERAMIDE HYDROCHLORIDE 1MG/5ML SOLUTION / ORAL 1995-11-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074352-001 LOPERAMIDE HYDROCHLORIDE 1MG/5ML SOLUTION / ORAL 1995-11-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074352-001 LOPERAMIDE HYDROCHLORIDE 1MG/5ML SOLUTION / ORAL 1995-11-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074352-001 LOPERAMIDE HYDROCHLORIDE 1MG/5ML SOLUTION / ORAL 1995-11-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A074352-001 LOPERAMIDE HYDROCHLORIDE 1MG/5ML SOLUTION / ORAL 1995-11-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074352-001 LOPERAMIDE HYDROCHLORIDE 1MG/5ML SOLUTION / ORAL 1995-11-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A074352-001 LOPERAMIDE HYDROCHLORIDE 1MG/5ML SOLUTION / ORAL 1995-11-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A074352-001 LOPERAMIDE HYDROCHLORIDE 1MG/5ML SOLUTION / ORAL 1995-11-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A074352-001 LOPERAMIDE HYDROCHLORIDE 1MG/5ML SOLUTION / ORAL 1995-11-17 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A074352-001 LOPERAMIDE HYDROCHLORIDE 1MG/5ML SOLUTION / ORAL 1995-11-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A074352-001 LOPERAMIDE HYDROCHLORIDE 1MG/5ML SOLUTION / ORAL 1995-11-17 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A074352-001 LOPERAMIDE HYDROCHLORIDE 1MG/5ML SOLUTION / ORAL 1995-11-17 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A074352-001 LOPERAMIDE HYDROCHLORIDE 1MG/5ML SOLUTION / ORAL 1995-11-17 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A074352-001 LOPERAMIDE HYDROCHLORIDE 1MG/5ML SOLUTION / ORAL 1995-11-17 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A074352-001 LOPERAMIDE HYDROCHLORIDE 1MG/5ML SOLUTION / ORAL 1995-11-17 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A074352-001 LOPERAMIDE HYDROCHLORIDE 1MG/5ML SOLUTION / ORAL 1995-11-17 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A074352-001 LOPERAMIDE HYDROCHLORIDE 1MG/5ML SOLUTION / ORAL 1995-11-17 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A074352-001 LOPERAMIDE HYDROCHLORIDE 1MG/5ML SOLUTION / ORAL 1995-11-17 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A074352-001 LOPERAMIDE HYDROCHLORIDE 1MG/5ML SOLUTION / ORAL 1995-11-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A074352-001 LOPERAMIDE HYDROCHLORIDE 1MG/5ML SOLUTION / ORAL 1995-11-17 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A074352-001 LOPERAMIDE HYDROCHLORIDE 1MG/5ML SOLUTION / ORAL 1995-11-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A074352-001 LOPERAMIDE HYDROCHLORIDE 1MG/5ML SOLUTION / ORAL 1995-11-17 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A074352-001 LOPERAMIDE HYDROCHLORIDE 1MG/5ML SOLUTION / ORAL 1995-11-17 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A074352-001 LOPERAMIDE HYDROCHLORIDE 1MG/5ML SOLUTION / ORAL 1995-11-17 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A074352-001 LOPERAMIDE HYDROCHLORIDE 1MG/5ML SOLUTION / ORAL 1995-11-17 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A074352-001 LOPERAMIDE HYDROCHLORIDE 1MG/5ML SOLUTION / ORAL 1995-11-17 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A074352-001 LOPERAMIDE HYDROCHLORIDE 1MG/5ML SOLUTION / ORAL 1995-11-17 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A074352-001 LOPERAMIDE HYDROCHLORIDE 1MG/5ML SOLUTION / ORAL 1995-11-17 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A074352-001 LOPERAMIDE HYDROCHLORIDE 1MG/5ML SOLUTION / ORAL 1995-11-17 f41ea6bd6efb…
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 4 of 7 · 132 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Anti-Diarrheal LOPERAMIDE HYDROCHLORIDE CHAIN DRUG MARKETING ASSOCIATION INC. 35a938af-decf-5b5d-e063-6294a90a9ab0 2025-05-21 Warnings Name fallback generic name: LOPERAMIDE HYDROCHLORIDE Anti-Diarrheal LOPERAMIDE HYDROCHLORIDE CHAIN DRUG MARKETING ASSOCIATION INC. 35aa2daf-3486-7ee2-e063-6394a90ad473 2025-05-21 Warnings Name fallback generic name: LOPERAMIDE HYDROCHLORIDE loperamide hydrochloride LOPERAMIDE HCL ATLANTIC BIOLOGICALS CORP. 7030f4ed-3cd1-428e-9cae-3b14933d41f5 2025-05-12 Warnings Name fallback brand name: loperamide hydrochloride Loperamide hydrochloride LOPERAMIDE HCL CVS Pharmacy 4c620875-1d8d-4170-be93-8649d9d99f4a 2025-04-11 Warnings Name fallback brand name: Loperamide hydrochloride anti-diarrheal LOPERAMIDE HYDROCHLORIDE Albertsons Companies 1d4ec76d-ff0d-a55d-e063-6294a90ae22c 2025-04-07 Warnings Name fallback generic name: LOPERAMIDE HYDROCHLORIDE LOPERAMIDE HYDROCHLORIDE LOPERAMIDE HYDROCHLORIDE Bryant Ranch Prepack 86d94804-ad01-4106-8f23-033f3a6bab9e 2025-02-05 Boxed warning, Warnings, Adverse reactions Name fallback brand name: LOPERAMIDE HYDROCHLORIDE generic name: LOPERAMIDE HYDROCHLORIDE anti diarrheal LOPERAMIDE HYDROCHLORIDE Redpharm Drug Inc f4c23673-056e-7608-e053-2995a90a9276 2025-01-23 Warnings Name fallback generic name: LOPERAMIDE HYDROCHLORIDE Loperamide Hydrochloride LOPERAMIDE HYDROCHLORIDE Aurohealth LLC f3ea8779-252e-4038-ae41-500e15c54825 2025-01-22 Warnings Name fallback brand name: Loperamide Hydrochloride generic name: LOPERAMIDE HYDROCHLORIDE Loperamide Hydrochloride LOPERAMIDE HYDROCHLORIDE AvPAK f8992723-dd9a-bcf6-e053-6294a90aa65c 2025-01-09 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Loperamide Hydrochloride generic name: LOPERAMIDE HYDROCHLORIDE Loperamide Hydrochloride LOPERAMIDE HYDROCHLORIDE Medline Industries, LP 03d68bcf-6413-4fe3-8263-39cc315452d2 2024-12-29 Warnings Name fallback brand name: Loperamide Hydrochloride generic name: LOPERAMIDE HYDROCHLORIDE Anti-Diarrheal LOPERAMIDE HYDROCHLORIDE DISCOUNT DRUG MART, INC. ed28814d-9733-46ff-930f-b148e31f2f51 2024-12-23 Warnings Name fallback generic name: LOPERAMIDE HYDROCHLORIDE Anti-Diarrheal LOPERAMIDE HYDROCHLORIDE KROGER COMPANY ff5dcb48-318c-4f2a-8df2-73ff6dd2a49e 2024-12-23 Warnings Name fallback generic name: LOPERAMIDE HYDROCHLORIDE Lil Drug Store Anti-Diarrheal LOPERAMIDE HYDROCHLORIDE Lil' Drug Store Products, Inc. fc23b13e-3005-4f23-aec2-b02a0e48ea11 2024-11-27 Warnings Name fallback generic name: LOPERAMIDE HYDROCHLORIDE dg health anti diarrheal LOPERAMIDE HYDROCHLORIDE Dolgencorp, LLC cac9e7e9-fb3a-497e-866d-347530ba4dfd 2024-11-11 Warnings Name fallback generic name: LOPERAMIDE HYDROCHLORIDE LOPERAMIDE HYDROCHLORIDE LOPERAMIDE HYDROCHLORIDE A-S Medication Solutions d572ecf7-ddc3-46fb-80a6-80b7b1b90a1b 2024-10-25 Boxed warning, Warnings, Adverse reactions Name fallback brand name: LOPERAMIDE HYDROCHLORIDE generic name: LOPERAMIDE HYDROCHLORIDE anti-diarrheal LOPERAMIDE HYDROCHLORIDE Safeway 9d0c565f-64a2-4300-b1e2-5dee9546ea14 2024-10-22 Warnings Name fallback generic name: LOPERAMIDE HYDROCHLORIDE LOPERAMIDE HYDROCHLORIDE LOPERAMIDE HYDROCHLORIDE NorthStar Rx LLC 858c2b62-98e6-46d7-9253-9b3a00040a4e 2024-10-21 Boxed warning, Warnings, Adverse reactions Name fallback brand name: LOPERAMIDE HYDROCHLORIDE generic name: LOPERAMIDE HYDROCHLORIDE anti-diarrheal LOPERAMIDE HYDROCHLORIDE PUBLIX SUPER MARKETS INC 17035ff7-8ba8-131c-e063-6394a90af5ea 2024-10-03 Warnings Name fallback generic name: LOPERAMIDE HYDROCHLORIDE Loperamide Hydrochloride LOPERAMIDE HYDROCHLORIDE Bryant Ranch Prepack 865cf4c7-f643-451b-b0d4-d30bda621f7d 2024-08-20 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Loperamide Hydrochloride generic name: LOPERAMIDE HYDROCHLORIDE LOPERAMIDE HYDROCHLORIDE LOPERAMIDE HYDROCHLORIDE NuCare Pharmaceuticals,Inc. 1adb7a28-9dc6-3f8b-e063-6394a90a9335 2024-08-19 Boxed warning, Warnings, Adverse reactions Name fallback brand name: LOPERAMIDE HYDROCHLORIDE generic name: LOPERAMIDE HYDROCHLORIDE
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 11 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 17856-0618 Loperamide Hydrochloride Loperamide Hydrochloride Atlantic Biologicals Corps ANDA Current 17856-0618 Loperamide Hydrochloride Loperamide Hydrochloride Atlantic Biologicals Corps ANDA Current 50090-0461 Loperamide Hydrochloride Loperamide Hydrochloride A-S Medication Solutions ANDA Current 50383-618 Loperamide Hydrochloride Loperamide Hydrochloride Hi-Tech Pharmacal Co., Inc. ANDA Current 50383-618 Loperamide Hydrochloride Loperamide Hydrochloride Hi-Tech Pharmacal Co., Inc. ANDA Current 50383-618 Loperamide Hydrochloride Loperamide Hydrochloride Akorn ANDA Current 68151-0618 Loperamide Hydrochloride Loperamide Hydrochloride Carilion Materials Management ANDA Current 68788-9773 Loperamide Hydrochloride Loperamide Hydrochloride Preferred Pharmaceuticals, Inc. ANDA Current 68788-9773 Loperamide Hydrochloride Loperamide Hydrochloride Preferred Pharmaceuticals, Inc. ANDA Current 68788-9773 Loperamide Hydrochloride Loperamide Hydrochloride Preferred Pharmaceuticals, Inc. ANDA Current 68788-9773 Loperamide Hydrochloride Loperamide Hydrochloride Preferred Pharmaceuticals, Inc. ANDA Current