Home NDC 36800-194 TopCare Acid Reducer
Product NDC 36800-194
11-digit product format 368000194
Labeler code 36800
Product ID 36800-194_4f159fc7-8379-465d-9a92-d3c8bffefdc6
Type HUMAN OTC DRUG
Nonproprietary name Famotidine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Topco Associates LLC
Application ANDA077351
Marketing category ANDA
Marketing start 2006-09-28
Substance FAMOTIDINE
Active strength 20 mg/1
Pharmacologic classes Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A077351-001 FAMOTIDINE FAMOTIDINE 20MG TABLET / ORAL 2006-09-25
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 · 41 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 2026-02-19 14:30 UTC 2026-02 A077351-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077351-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077351-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077351-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077351-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077351-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077351-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077351-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077351-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077351-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077351-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077351-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077351-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077351-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077351-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A077351-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A077351-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A077351-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A077351-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A077351-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A077351-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A077351-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A077351-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A077351-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A077351-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A077351-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A077351-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A077351-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A077351-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A077351-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A077351-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A077351-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A077351-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A077351-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A077351-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A077351-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A077351-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A077351-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A077351-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A077351-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 cb3db0bc1861…
Additional Listing Data#
Finished product Yes
Brand name base TopCare Acid Reducer
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FAMOTIDINE 20 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 5QZO15J2Z8 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 310273 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 36800-194-02 TopCare Acid Reducer 25 in 1 CARTON TABLET, FILM COATED 25 10 36800-194-02 TopCare Acid Reducer 1 in 1 BLISTER PACK TABLET, FILM COATED 1 10 36800-194-51 TopCare Acid Reducer 8 in 1 CARTON TABLET, FILM COATED 8 10 36800-194-51 TopCare Acid Reducer 1 in 1 BLISTER PACK TABLET, FILM COATED 1 10 36800-194-71 TopCare Acid Reducer 1 in 1 CARTON TABLET, FILM COATED 1 10 36800-194-71 TopCare Acid Reducer 50 in 1 BOTTLE TABLET, FILM COATED 50 10 36800-194-78 TopCare Acid Reducer 100 in 1 BOTTLE TABLET, FILM COATED 100 10 36800-194-78 TopCare Acid Reducer 1 in 1 CARTON TABLET, FILM COATED 1 10
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 36800-194 TOPCARE ACID REDUCER (FAMOTIDINE) TABLET, FILM COATED [TOPCO ASSOCIATES LLC] 9 Current NDC, Legacy NDC, 8 package rows 20250213_c3c9ae86-f6d7-4a6c-a991-be8ef7c6adbe.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 3 · 42 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 36800-194-02 36800019402 25 BLISTER PACK in 1 CARTON (36800-194-02) / 1 TABLET, FILM COATED in 1 BLISTER PACK 25 blister pack 2006-09-28 0000-00-00 No No Current 36800-194-51 36800019451 8 BLISTER PACK in 1 CARTON (36800-194-51) > 1 TABLET, FILM COATED in 1 BLISTER PACK 8 blister pack 2006-10-16 0000-00-00 No No Current 36800-194-71 36800019471 1 BOTTLE in 1 CARTON (36800-194-71) / 50 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2006-10-16 0000-00-00 No No Current 36800-194-78 36800019478 1 BOTTLE in 1 CARTON (36800-194-78) / 100 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2021-02-02 0000-00-00 No No Current