Home NDC 65862-074 Citalopram Hydrobromide
Product NDC 65862-074
11-digit product format 658620074
Labeler code 65862
Product ID 65862-074_7cecadcf-9da0-41e4-b9fd-0fe04572dcd8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Citalopram Hydrobromide
Dosage form SOLUTION
Route ORAL
Labeler Aurobindo Pharma Limited
Application ANDA077812
Marketing category ANDA
Marketing start 2006-08-28
Substance CITALOPRAM HYDROBROMIDE
Active strength 10 mg/5mL
Pharmacologic classes Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
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 A077812-001 CITALOPRAM HYDROBROMIDE CITALOPRAM HYDROBROMIDE EQ 10MG BASE/5ML SOLUTION / ORAL AA 2006-08-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A077812-001 AA
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 A077812-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE/5ML SOLUTION / ORAL AA 2006-08-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077812-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE/5ML SOLUTION / ORAL AA 2006-08-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077812-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE/5ML SOLUTION / ORAL AA 2006-08-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077812-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE/5ML SOLUTION / ORAL AA 2006-08-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077812-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE/5ML SOLUTION / ORAL AA 2006-08-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077812-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE/5ML SOLUTION / ORAL AA 2006-08-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077812-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE/5ML SOLUTION / ORAL AA 2006-08-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077812-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE/5ML SOLUTION / ORAL AA 2006-08-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077812-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE/5ML SOLUTION / ORAL AA 2006-08-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077812-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE/5ML SOLUTION / ORAL AA 2006-08-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077812-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE/5ML SOLUTION / ORAL AA 2006-08-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077812-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE/5ML SOLUTION / ORAL AA 2006-08-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077812-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE/5ML SOLUTION / ORAL AA 2006-08-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077812-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE/5ML SOLUTION / ORAL AA 2006-08-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077812-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE/5ML SOLUTION / ORAL AA 2006-08-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A077812-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE/5ML SOLUTION / ORAL AA 2006-08-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A077812-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE/5ML SOLUTION / ORAL AA 2006-08-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A077812-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE/5ML SOLUTION / ORAL AA 2006-08-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A077812-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE/5ML SOLUTION / ORAL AA 2006-08-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A077812-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE/5ML SOLUTION / ORAL AA 2006-08-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A077812-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE/5ML SOLUTION / ORAL AA 2006-08-28 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A077812-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE/5ML SOLUTION / ORAL AA 2006-08-28 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A077812-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE/5ML SOLUTION / ORAL AA 2006-08-28 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A077812-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE/5ML SOLUTION / ORAL AA 2006-08-28 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A077812-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE/5ML SOLUTION / ORAL AA 2006-08-28 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A077812-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE/5ML SOLUTION / ORAL AA 2006-08-28 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A077812-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE/5ML SOLUTION / ORAL AA 2006-08-28 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A077812-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE/5ML SOLUTION / ORAL AA 2006-08-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A077812-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE/5ML SOLUTION / ORAL AA 2006-08-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A077812-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE/5ML SOLUTION / ORAL AA 2006-08-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A077812-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE/5ML SOLUTION / ORAL AA 2006-08-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A077812-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE/5ML SOLUTION / ORAL AA 2006-08-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A077812-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE/5ML SOLUTION / ORAL AA 2006-08-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A077812-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE/5ML SOLUTION / ORAL AA 2006-08-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A077812-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE/5ML SOLUTION / ORAL AA 2006-08-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A077812-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE/5ML SOLUTION / ORAL AA 2006-08-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A077812-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE/5ML SOLUTION / ORAL AA 2006-08-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A077812-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE/5ML SOLUTION / ORAL AA 2006-08-28 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A077812-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE/5ML SOLUTION / ORAL AA 2006-08-28 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A077812-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE/5ML SOLUTION / ORAL AA 2006-08-28 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 Citalopram Hydrobromide
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CITALOPRAM HYDROBROMIDE 10 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination I1E9D14F36 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 309313 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 65862-074-24 Citalopram Hydrobromide 240 mL in 1 BOTTLE SOLUTION 240 19
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65862-074 CITALOPRAM HYDROBROMIDE SOLUTION [AUROBINDO PHARMA LIMITED] 19 Current NDC, Legacy NDC, 1 package rows 20240509_e7a2cbdd-1bdb-4e59-a3dd-298a189753ae.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 65862-074-24 65862007424 240 mL in 1 BOTTLE (65862-074-24) 240 ml 2006-08-28 0000-00-00 No No Current