Home NDC 70377-113-11 FAMOTIDINE
Product NDC 70377-113
Requested package NDC 70377-113-11
11-digit product format 703770113
Labeler code 70377
Product ID 70377-113_c9c5c51c-c406-82ad-ad7b-ff0dac43503a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name FAMOTIDINE
Dosage form POWDER, FOR SUSPENSION
Route ORAL
Labeler Biocon Pharma Inc.
Application ANDA217137
Marketing category ANDA
Marketing start 2023-09-01
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 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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A217137-001 FAMOTIDINE FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2023-07-07
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A217137-001 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 A217137-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2023-07-07 84e616aacf4f…2026-08-18 06:07:40 2026-07 A217137-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2023-07-07 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A217137-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2023-07-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217137-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2023-07-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217137-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2023-07-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217137-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2023-07-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217137-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2023-07-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217137-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2023-07-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217137-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2023-07-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217137-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2023-07-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217137-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2023-07-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A217137-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2023-07-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217137-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2023-07-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A217137-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2023-07-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A217137-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2023-07-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A217137-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2023-07-07 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A217137-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2023-07-07 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A217137-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2023-07-07 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A217137-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2023-07-07 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A217137-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2023-07-07 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A217137-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2023-07-07 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A217137-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2023-07-07 a67488948f0b…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217137-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2023-07-07 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 2026-12-31 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 70377-113-11 FAMOTIDINE 50 mL in 1 BOTTLE POWDER, FOR SUSPENSION 50 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70377-113 FAMOTIDINE POWDER, FOR SUSPENSION [BIOCON PHARMA INC.] 3 Current NDC, 1 package rows 20230901_ea7287a4-75e0-39d2-5b2e-b72b7cb386b9.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 · 3 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 70377-113-11 70377011311 50 mL in 1 BOTTLE (70377-113-11) 50 ml 2023-09-01 No No Current