FDA.reportPublic FDA data

Acid Reducer

Product NDC
43598-960
11-digit product format
435980960
Labeler code
43598
Product ID
43598-960_04bc02ec-359b-bf7a-d622-4c8ee4075397
Type
HUMAN OTC DRUG
Nonproprietary name
Famotidine
Dosage form
TABLET
Route
ORAL
Labeler
Dr.Reddys Laboratories Inc.
Application
ANDA077367
Marketing category
ANDA
Marketing start
2020-09-01
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

Additional Listing Data#

Finished product
Yes
Brand name base
Acid Reducer
Brand name suffix
Maximum Strength
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FAMOTIDINE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5QZO15J2Z8
Rxcui199047, 310273

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
396bde5c-c78e-2f8b-ab1f-2ee6ba32bcaeProduct name720260317
1e73f975-1ce7-705e-2bcf-788b1b5e24baProduct name520251124
cf645750-2e70-f6e1-c05a-a52847def5ddProduct name920250312
4fdc761c-585e-054b-8ebe-86130a26e4c1Product name220221205
fc2e1e31-353a-2c24-a4b4-fcf93bf7e38eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43598-960-32Acid Reducer Maximum Strength1 in 1 CARTONTABLET19
43598-960-32Acid Reducer Maximum Strength170 in 1 BOTTLETABLET1709
43598-960-65Acid Reducer Maximum Strength65 in 1 BOTTLETABLET659
43598-960-65Acid Reducer Maximum Strength1 in 1 CARTONTABLET19
43598-960-91Acid Reducer Maximum Strength90 in 1 BOTTLETABLET909
43598-960-91Acid Reducer Maximum Strength1 in 1 CARTONTABLET19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-960ACID REDUCER ORIGINAL STRENGTH (FAMOTIDINE) TABLET ACID REDUCER MAXIMUM STRENGTH (FAMOTIDINE) TABLET [DR.REDDYS LABORATORIES INC.]8Current NDC, Legacy NDC, 6 package rows20241024_ca039876-f7e5-3e60-da5a-a1f40637a417.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199047famotidine 10 MG Oral TabletPSNca039876-f7e5-3e60-da5a-a1f40637a4179
310273famotidine 20 MG Oral TabletPSNca039876-f7e5-3e60-da5a-a1f40637a4179
199047famotidine 10 MG Oral TabletSCDca039876-f7e5-3e60-da5a-a1f40637a4179
310273famotidine 20 MG Oral TabletSCDca039876-f7e5-3e60-da5a-a1f40637a4179

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43598-960-32435980960321 BOTTLE in 1 CARTON (43598-960-32) / 170 TABLET in 1 BOTTLE1 bottle2020-09-010000-00-00NoNoCurrent
43598-960-65435980960651 BOTTLE in 1 CARTON (43598-960-65) / 65 TABLET in 1 BOTTLE1 bottle2020-09-010000-00-00NoNoCurrent
43598-960-91435980960911 BOTTLE in 1 CARTON (43598-960-91) / 90 TABLET in 1 BOTTLE1 bottle2021-10-070000-00-00NoNoCurrent