Home NDC 68180-150 Famotidine
Product NDC 68180-150
11-digit product format 681800150
Labeler code 68180
Product ID 68180-150_ce0e39ea-0d29-4922-95cb-8777326a994e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Famotidine
Dosage form POWDER, FOR SUSPENSION
Route ORAL
Labeler Lupin Pharmaceuticals, Inc.
Application ANDA090440
Marketing category ANDA
Marketing start 2010-06-29
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 A090440-001 FAMOTIDINE FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2010-06-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A090440-001 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 · 43 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 2026-09-14 22:38:34 2026-08 A090440-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2010-06-29 84e616aacf4f…2026-08-18 06:07:40 2026-07 A090440-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2010-06-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A090440-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2010-06-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090440-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2010-06-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090440-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2010-06-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090440-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2010-06-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090440-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2010-06-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090440-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2010-06-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090440-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2010-06-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090440-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2010-06-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090440-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2010-06-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090440-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2010-06-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090440-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2010-06-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090440-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2010-06-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090440-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2010-06-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090440-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2010-06-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090440-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB RS 2010-06-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090440-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB RS 2010-06-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090440-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB RS 2010-06-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090440-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2010-06-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A090440-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB RS 2010-06-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A090440-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB RS 2010-06-29 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A090440-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB RS 2010-06-29 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A090440-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB RS 2010-06-29 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A090440-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB RS 2010-06-29 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A090440-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB RS 2010-06-29 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A090440-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB RS 2010-06-29 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A090440-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2010-06-29 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A090440-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2010-06-29 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A090440-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2010-06-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A090440-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2010-06-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A090440-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2010-06-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A090440-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2010-06-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A090440-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2010-06-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A090440-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2010-06-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A090440-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB RS 2010-06-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A090440-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB RS 2010-06-29 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A090440-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB RS 2010-06-29 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A090440-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB RS 2010-06-29 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A090440-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB RS 2010-06-29 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
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 68180-150-01 Famotidine 50 mL in 1 BOTTLE POWDER, FOR SUSPENSION 50 9
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded FAMOTIDINE ACTIVE INGREDIENT 5QZO15J2Z8 FAMOTIDINE POWDER, FOR SUSPENSION [LUPIN PHARMACEUTICALS, INC] 4 FAMOTIDINE ACTIVE MOIETY 5QZO15J2Z8 FAMOTIDINE POWDER, FOR SUSPENSION [LUPIN PHARMACEUTICALS, INC] 4 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP FAMOTIDINE POWDER, FOR SUSPENSION [LUPIN PHARMACEUTICALS, INC] 4 METHYLPARABEN SODIUM INACTIVE INGREDIENT CR6K9C2NHK FAMOTIDINE POWDER, FOR SUSPENSION [LUPIN PHARMACEUTICALS, INC] 4 POWDERED CELLULOSE INACTIVE INGREDIENT SMD1X3XO9M FAMOTIDINE POWDER, FOR SUSPENSION [LUPIN PHARMACEUTICALS, INC] 4 PROPYLPARABEN SODIUM INACTIVE INGREDIENT 625NNB0G9N FAMOTIDINE POWDER, FOR SUSPENSION [LUPIN PHARMACEUTICALS, INC] 4 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU FAMOTIDINE POWDER, FOR SUSPENSION [LUPIN PHARMACEUTICALS, INC] 4 SUCROSE INACTIVE INGREDIENT C151H8M554 FAMOTIDINE POWDER, FOR SUSPENSION [LUPIN PHARMACEUTICALS, INC] 4 XANTHAN GUM INACTIVE INGREDIENT TTV12P4NEE FAMOTIDINE POWDER, FOR SUSPENSION [LUPIN PHARMACEUTICALS, INC] 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68180-150 FAMOTIDINE POWDER, FOR SUSPENSION [LUPIN PHARMACEUTICALS, INC.] 7 Current NDC, Legacy NDC, 1 package rows 20200425_2caaf94b-b382-4573-8614-57815776b659.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 68180-150-01 68180015001 50 mL in 1 BOTTLE (68180-150-01) 50 ml 2010-06-29 0000-00-00 No No Current