Home NDC 69168-443-32 Acid Reducer
Product NDC 69168-443
Requested package NDC 69168-443-32
11-digit product format 691680443
Labeler code 69168
Product ID 69168-443_10efebb0-5d63-4c46-8934-9e91b213a543
Type HUMAN OTC DRUG
Nonproprietary name Famotidine
Dosage form TABLET
Route ORAL
Labeler Allegiant Health
Application ANDA215822
Marketing category ANDA
Marketing start 2024-01-15
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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A215822-001 FAMOTIDINE FAMOTIDINE 10MG TABLET / ORAL 2022-01-28 A215822-002 FAMOTIDINE FAMOTIDINE 20MG TABLET / ORAL 2022-01-28
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 · 68 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 A215822-001 FAMOTIDINE 10MG TABLET / ORAL 2022-01-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 A215822-002 FAMOTIDINE 20MG TABLET / ORAL 2022-01-28 84e616aacf4f…2026-08-18 06:07:40 2026-07 A215822-001 FAMOTIDINE 10MG TABLET / ORAL 2022-01-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A215822-002 FAMOTIDINE 20MG TABLET / ORAL 2022-01-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A215822-001 FAMOTIDINE 10MG TABLET / ORAL 2022-01-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A215822-002 FAMOTIDINE 20MG TABLET / ORAL 2022-01-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215822-001 FAMOTIDINE 10MG TABLET / ORAL 2022-01-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215822-002 FAMOTIDINE 20MG TABLET / ORAL 2022-01-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215822-001 FAMOTIDINE 10MG TABLET / ORAL 2022-01-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A215822-002 FAMOTIDINE 20MG TABLET / ORAL 2022-01-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215822-001 FAMOTIDINE 10MG TABLET / ORAL 2022-01-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215822-002 FAMOTIDINE 20MG TABLET / ORAL 2022-01-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215822-001 FAMOTIDINE 10MG TABLET / ORAL 2022-01-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215822-002 FAMOTIDINE 20MG TABLET / ORAL 2022-01-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215822-001 FAMOTIDINE 10MG TABLET / ORAL 2022-01-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215822-002 FAMOTIDINE 20MG TABLET / ORAL 2022-01-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215822-001 FAMOTIDINE 10MG TABLET / ORAL 2022-01-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215822-002 FAMOTIDINE 20MG TABLET / ORAL 2022-01-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215822-001 FAMOTIDINE 10MG TABLET / ORAL 2022-01-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215822-002 FAMOTIDINE 20MG TABLET / ORAL 2022-01-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215822-001 FAMOTIDINE 10MG TABLET / ORAL 2022-01-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215822-002 FAMOTIDINE 20MG TABLET / ORAL 2022-01-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A215822-001 FAMOTIDINE 10MG TABLET / ORAL 2022-01-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A215822-002 FAMOTIDINE 20MG TABLET / ORAL 2022-01-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215822-001 FAMOTIDINE 10MG TABLET / ORAL 2022-01-28 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215822-002 FAMOTIDINE 20MG TABLET / ORAL 2022-01-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215822-001 FAMOTIDINE 10MG TABLET / ORAL 2022-01-28 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215822-002 FAMOTIDINE 20MG TABLET / ORAL 2022-01-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215822-001 FAMOTIDINE 10MG TABLET / ORAL 2022-01-28 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215822-002 FAMOTIDINE 20MG TABLET / ORAL 2022-01-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A215822-001 FAMOTIDINE 10MG TABLET / ORAL 2022-01-28 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A215822-002 FAMOTIDINE 20MG TABLET / ORAL 2022-01-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A215822-001 FAMOTIDINE 10MG TABLET / ORAL 2022-01-28 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A215822-002 FAMOTIDINE 20MG TABLET / ORAL 2022-01-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A215822-001 FAMOTIDINE 10MG TABLET / ORAL 2022-01-28 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A215822-002 FAMOTIDINE 20MG TABLET / ORAL 2022-01-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A215822-001 FAMOTIDINE 10MG TABLET / ORAL 2022-01-28 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A215822-002 FAMOTIDINE 20MG TABLET / ORAL 2022-01-28 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A215822-001 FAMOTIDINE 10MG TABLET / ORAL 2022-01-28 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A215822-002 FAMOTIDINE 20MG TABLET / ORAL 2022-01-28 bb7c543d1eb4…
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 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 69168-443-09 Acid Reducer 10 in 1 BLISTER PACK TABLET 10 5 69168-443-32 Acid Reducer 100 in 1 BOTTLE TABLET 100 5 69168-443-50 Acid Reducer 1 in 1 CARTON TABLET 1 5 69168-443-50 Acid Reducer 50 in 1 BOTTLE TABLET 50 5 69168-443-52 Acid Reducer 225 in 1 BOTTLE TABLET 225 5 69168-443-99 Acid Reducer 365 in 1 BOTTLE TABLET 365 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69168-443 ACID REDUCER MAXIMUM STRENGTH (FAMOTODINE) TABLET [ALLEGIANT HEALTH] 4 Current NDC, 6 package rows 20241030_adc2721d-2ca7-4a47-bae1-be298fa1c155.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 1 · 16 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 69168-443-32 69168044332 100 TABLET in 1 BOTTLE (69168-443-32) 100 tablet 2024-01-15 No No Current