Home NDC 43386-500 Famotidine
Product NDC 43386-500
11-digit product format 433860500
Labeler code 43386
Product ID 43386-500_82462011-668a-4fbd-9653-48049901eacc
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Famotidine
Dosage form FOR SUSPENSION
Route ORAL
Labeler Lupin Pharmaceuticals,Inc.
Application ANDA201695
Marketing category ANDA
Marketing start 2012-12-17
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 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 A201695-001 FAMOTIDINE FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2012-12-17
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A201695-001 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.
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 A201695-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2012-12-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201695-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2012-12-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A201695-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2012-12-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201695-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2012-12-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201695-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2012-12-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201695-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2012-12-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201695-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2012-12-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201695-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2012-12-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A201695-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2012-12-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A201695-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2012-12-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A201695-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2012-12-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A201695-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2012-12-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A201695-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2012-12-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A201695-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2012-12-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A201695-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2012-12-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A201695-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2012-12-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A201695-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2012-12-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A201695-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2012-12-17 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A201695-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2012-12-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A201695-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2012-12-17 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A201695-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2012-12-17 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A201695-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2012-12-17 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A201695-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2012-12-17 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A201695-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2012-12-17 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A201695-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2012-12-17 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A201695-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2012-12-17 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A201695-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2012-12-17 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A201695-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2012-12-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A201695-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2012-12-17 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A201695-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2012-12-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A201695-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2012-12-17 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A201695-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2012-12-17 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A201695-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2012-12-17 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A201695-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2012-12-17 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A201695-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2012-12-17 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A201695-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2012-12-17 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A201695-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2012-12-17 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A201695-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2012-12-17 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A201695-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2012-12-17 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A201695-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2012-12-17 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
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 43386-500-11 Famotidine 50 mL in 1 BOTTLE FOR SUSPENSION 50 2
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded FAMOTIDINE ACTIVE INGREDIENT 5QZO15J2Z8 FAMOTIDINE FOR SUSPENSION [GAVIS PHARMACEUTICALS, LLC] 1 FAMOTIDINE ACTIVE MOIETY 5QZO15J2Z8 FAMOTIDINE FOR SUSPENSION [GAVIS PHARMACEUTICALS, LLC] 1 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL FAMOTIDINE FOR SUSPENSION [GAVIS PHARMACEUTICALS, LLC] 1 CARBOXYMETHYLCELLULOSE SODIUM INACTIVE INGREDIENT K679OBS311 FAMOTIDINE FOR SUSPENSION [GAVIS PHARMACEUTICALS, LLC] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U FAMOTIDINE FOR SUSPENSION [GAVIS PHARMACEUTICALS, LLC] 1 METHYLPARABEN SODIUM INACTIVE INGREDIENT CR6K9C2NHK FAMOTIDINE FOR SUSPENSION [GAVIS PHARMACEUTICALS, LLC] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 FAMOTIDINE FOR SUSPENSION [GAVIS PHARMACEUTICALS, LLC] 1 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU FAMOTIDINE FOR SUSPENSION [GAVIS PHARMACEUTICALS, LLC] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ FAMOTIDINE FOR SUSPENSION [GAVIS PHARMACEUTICALS, LLC] 1 SUCROSE INACTIVE INGREDIENT C151H8M554 FAMOTIDINE FOR SUSPENSION [GAVIS PHARMACEUTICALS, LLC] 1 XANTHAN GUM INACTIVE INGREDIENT TTV12P4NEE FAMOTIDINE FOR SUSPENSION [GAVIS PHARMACEUTICALS, LLC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43386-500 FAMOTIDINE FOR SUSPENSION [LUPIN PHARMACEUTICALS,INC.] 2 Current NDC, Legacy NDC, 1 package rows 20171122_a0bdf4d1-8458-4e4f-95aa-bcc38c0f32f8.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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 43386-500-11 43386050011 50 mL in 1 BOTTLE (43386-500-11) 50 ml 2012-12-17 0000-00-00 No No Current