Home NDC 40032-500 Famotidine
Product NDC 40032-500
11-digit product format 400320500
Labeler code 40032
Product ID 40032-500_d476f4fa-86f9-45f0-bfb0-64b3e34a6d83
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Famotidine
Dosage form FOR SUSPENSION
Route ORAL
Labeler Novel Laboratories, Inc.
Application ANDA201695
Marketing category ANDA
Marketing start 2012-12-17
Marketing end 0000-00-00
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 2019-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 42 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 40032-500-11 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 40032-500-11 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 40032-500-11 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 40032-500-11 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 40032-500-11 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 40032-500-11 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 40032-500-11 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 40032-500-11 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 40032-500-11 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 40032-500-11 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 40032-500-11 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 40032-500-11 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 40032-500-11 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 40032-500-11 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 40032-500-11 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 40032-500-11 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 40032-500-11 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 40032-500-11 bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 40032-500-11 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 40032-500-11 e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 40032-500-11 9bebd1f3094a…5416666fcb17…
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.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 40032-500-11 Famotidine 50 mL in 1 BOTTLE FOR SUSPENSION 50 4
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded FAMOTIDINE ACTIVE INGREDIENT 5QZO15J2Z8 FAMOTIDINE FOR SUSPENSION [NOVEL LABORATORIES, INC.] 4 FAMOTIDINE ACTIVE MOIETY 5QZO15J2Z8 FAMOTIDINE FOR SUSPENSION [NOVEL LABORATORIES, INC.] 4 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL FAMOTIDINE FOR SUSPENSION [NOVEL LABORATORIES, INC.] 4 CARBOXYMETHYLCELLULOSE SODIUM INACTIVE INGREDIENT K679OBS311 FAMOTIDINE FOR SUSPENSION [NOVEL LABORATORIES, INC.] 4 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U FAMOTIDINE FOR SUSPENSION [NOVEL LABORATORIES, INC.] 4 METHYLPARABEN SODIUM INACTIVE INGREDIENT CR6K9C2NHK FAMOTIDINE FOR SUSPENSION [NOVEL LABORATORIES, INC.] 4 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 FAMOTIDINE FOR SUSPENSION [NOVEL LABORATORIES, INC.] 4 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU FAMOTIDINE FOR SUSPENSION [NOVEL LABORATORIES, INC.] 4 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ FAMOTIDINE FOR SUSPENSION [NOVEL LABORATORIES, INC.] 4 SUCROSE INACTIVE INGREDIENT C151H8M554 FAMOTIDINE FOR SUSPENSION [NOVEL LABORATORIES, INC.] 4 XANTHAN GUM INACTIVE INGREDIENT TTV12P4NEE FAMOTIDINE FOR SUSPENSION [NOVEL LABORATORIES, INC.] 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 40032-500 FAMOTIDINE FOR SUSPENSION [NOVEL LABORATORIES, INC.] 4 Legacy NDC, 1 package rows 20130108_a6330a0d-4c67-4019-9700-7383fad7cbc7.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 Status 40032-500-11 40032050011 50 mL in 1 BOTTLE 50 ml Historical