Home NDC 42507-194 ACID REDUCER
Product NDC 42507-194
11-digit product format 425070194
Labeler code 42507
Product ID 42507-194_b87aab55-018f-4b26-86ed-c733a5e756a5
Type HUMAN OTC DRUG
Nonproprietary name Famotidine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler HyVee Inc
Application ANDA077351
Marketing category ANDA
Marketing start 2026-02-25
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 2027-12-31
Current FDA listing Yes 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 ACID REDUCER
Listing expiration 2027-12-31 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 42507-194-01 ACID REDUCER 25 in 1 CARTON TABLET, FILM COATED 25 2 42507-194-01 ACID REDUCER 1 in 1 BLISTER PACK TABLET, FILM COATED 1 2 42507-194-50 ACID REDUCER 50 in 1 BOTTLE TABLET, FILM COATED 50 2 42507-194-71 ACID REDUCER 1 in 1 CARTON TABLET, FILM COATED 1 2
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 Sample Exclude flag Status 42507-194-01 42507019401 25 BLISTER PACK in 1 CARTON (42507-194-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK 25 blister pack 2026-02-25 No No Current 42507-194-50 42507019450 50 in 1 BOTTLE Historical 42507-194-71 42507019471 1 BOTTLE in 1 CARTON (42507-194-71) / 50 TABLET, FILM COATED in 1 BOTTLE (42507-194-50) 1 bottle 2026-02-25 No No Current 42507-194-78 42507019478 1 BOTTLE in 1 CARTON (42507-194-78) / 100 TABLET, FILM COATED in 1 BOTTLE (42507-194-00) 1 bottle 2026-03-18 0 Current