Home NDC 59651-701 FAMOTIDINE
Product NDC 59651-701
11-digit product format 596510701
Labeler code 59651
Product ID 59651-701_186342b3-2a01-4582-8978-41f059d4307d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name FAMOTIDINE
Dosage form POWDER, FOR SUSPENSION
Route ORAL
Labeler Aurobindo Pharma Limited
Application ANDA219091
Marketing category ANDA
Marketing start 2025-07-09
Substance FAMOTIDINE
Active strength 40 mg/5mL
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 43 .
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 A219091-001 FAMOTIDINE FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2025-07-09
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A219091-001 AB
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 2026-09-14 22:38:34 2026-08 A219091-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2025-07-09 84e616aacf4f…2026-08-18 06:07:40 2026-07 A219091-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2025-07-09 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A219091-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2025-07-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219091-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2025-07-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A219091-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2025-07-09 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219091-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2025-07-09 a50c72e98297…
Observed Orange Book normalized TE history# 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 FAMOTIDINE
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FAMOTIDINE 40 mg/5mL
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 310274 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 59651-701-50 FAMOTIDINE 50 mL in 1 BOTTLE POWDER, FOR SUSPENSION 50 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 1 · 1 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 59651-701-50 59651070150 50 mL in 1 BOTTLE (59651-701-50) 50 ml 2025-07-09 No No Current