Home NDC 62207-739 Loperamide Hydrochloride and Simethicone
Product NDC 62207-739
11-digit product format 622070739
Labeler code 62207
Product ID 62207-739_5d3e732d-11b2-21cc-e063-6394a90a97e2
Type HUMAN OTC DRUG
Nonproprietary name Loperamide Hydrochloride and Simethicone
Dosage form TABLET
Route ORAL
Labeler Granules India Ltd
Application ANDA215981
Marketing category ANDA
Marketing start 2023-03-01
Substance LOPERAMIDE HYDROCHLORIDE; DIMETHICONE
Active strength 2; 125 mg/1; mg/1
Pharmacologic classes Opioid Agonist [EPC], Opioid Agonists [MoA], Skin Barrier Activity [PE]
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 44 .
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 A215981-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE LOPERAMIDE HYDROCHLORIDE; SIMETHICONE 2MG;125MG TABLET / ORAL 2022-08-29
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 table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-10-15 13:18:30 2026-09 A215981-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2022-08-29 c2088c7a36db…2026-09-14 22:38:34 2026-08 A215981-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2022-08-29 84e616aacf4f…2026-08-18 06:07:40 2026-07 A215981-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2022-08-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A215981-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2022-08-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215981-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2022-08-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215981-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2022-08-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215981-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2022-08-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215981-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2022-08-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215981-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2022-08-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215981-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2022-08-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215981-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2022-08-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215981-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2022-08-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A215981-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2022-08-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215981-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2022-08-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215981-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2022-08-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215981-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2022-08-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A215981-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2022-08-29 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A215981-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2022-08-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A215981-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2022-08-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A215981-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2022-08-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A215981-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2022-08-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A215981-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2022-08-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A215981-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2022-08-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A215981-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2022-08-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A215981-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2022-08-29 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A215981-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2022-08-29 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A215981-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2022-08-29 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A215981-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2022-08-29 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A215981-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2022-08-29 e64feba35796…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215981-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 2MG;125MG TABLET / ORAL 2022-08-29 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 Loperamide Hydrochloride and Simethicone
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LOPERAMIDE HYDROCHLORIDE 2 mg/1 DIMETHICONE 125 mg/1
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 62207-739-69 Loperamide Hydrochloride and Simethicone 2 in 1 CARTON TABLET 2 3 62207-739-69 Loperamide Hydrochloride and Simethicone 6 in 1 BLISTER PACK TABLET 6 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62207-739 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE TABLET [GRANULES INDIA LTD] 2 Current NDC, 2 package rows 20230301_e0c1693e-0e55-4368-a8a5-2f0882fbf952.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 62207-739-69 62207073969 2 BLISTER PACK in 1 CARTON (62207-739-69) / 6 TABLET in 1 BLISTER PACK 2 blister pack 2023-03-01 No No Current