Home NDC 43353-778 Citalopram
Product NDC 43353-778
11-digit product format 433530778
Labeler code 43353
Product ID 43353-778_e2548afb-c594-4b3a-8557-162db8daa689
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Citalopram
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Aphena Pharma Solutions - Tennessee, LLC
Application ANDA077045
Marketing category ANDA
Marketing start 2011-05-20
Marketing end 0000-00-00
Substance CITALOPRAM HYDROBROMIDE
Active strength 20 mg/1
Pharmacologic classes Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2020-12-31
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 2 · 76 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A077045-001 CITALOPRAM HYDROBROMIDE CITALOPRAM HYDROBROMIDE EQ 40MG BASE TABLET / ORAL AB 2005-04-29 A077045-002 CITALOPRAM HYDROBROMIDE CITALOPRAM HYDROBROMIDE EQ 20MG BASE TABLET / ORAL AB 2005-04-29 A077045-003 CITALOPRAM HYDROBROMIDE CITALOPRAM HYDROBROMIDE EQ 10MG BASE TABLET / ORAL AB 2005-04-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 4 · 129 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 A077045-001 CITALOPRAM HYDROBROMIDE EQ 40MG BASE TABLET / ORAL AB 2005-04-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077045-002 CITALOPRAM HYDROBROMIDE EQ 20MG BASE TABLET / ORAL AB 2005-04-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077045-003 CITALOPRAM HYDROBROMIDE EQ 10MG BASE TABLET / ORAL AB 2005-04-29 84e616aacf4f…2026-08-18 06:07:40 2026-07 A077045-001 CITALOPRAM HYDROBROMIDE EQ 40MG BASE TABLET / ORAL AB 2005-04-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077045-002 CITALOPRAM HYDROBROMIDE EQ 20MG BASE TABLET / ORAL AB 2005-04-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077045-003 CITALOPRAM HYDROBROMIDE EQ 10MG BASE TABLET / ORAL AB 2005-04-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077045-001 CITALOPRAM HYDROBROMIDE EQ 40MG BASE TABLET / ORAL AB 2005-04-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077045-002 CITALOPRAM HYDROBROMIDE EQ 20MG BASE TABLET / ORAL AB 2005-04-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077045-003 CITALOPRAM HYDROBROMIDE EQ 10MG BASE TABLET / ORAL AB 2005-04-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077045-001 CITALOPRAM HYDROBROMIDE EQ 40MG BASE TABLET / ORAL AB 2005-04-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077045-002 CITALOPRAM HYDROBROMIDE EQ 20MG BASE TABLET / ORAL AB 2005-04-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077045-003 CITALOPRAM HYDROBROMIDE EQ 10MG BASE TABLET / ORAL AB 2005-04-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077045-001 CITALOPRAM HYDROBROMIDE EQ 40MG BASE TABLET / ORAL AB 2005-04-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077045-002 CITALOPRAM HYDROBROMIDE EQ 20MG BASE TABLET / ORAL AB 2005-04-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077045-003 CITALOPRAM HYDROBROMIDE EQ 10MG BASE TABLET / ORAL AB 2005-04-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077045-001 CITALOPRAM HYDROBROMIDE EQ 40MG BASE TABLET / ORAL AB 2005-04-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077045-002 CITALOPRAM HYDROBROMIDE EQ 20MG BASE TABLET / ORAL AB 2005-04-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077045-003 CITALOPRAM HYDROBROMIDE EQ 10MG BASE TABLET / ORAL AB 2005-04-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077045-001 CITALOPRAM HYDROBROMIDE EQ 40MG BASE TABLET / ORAL AB 2005-04-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077045-002 CITALOPRAM HYDROBROMIDE EQ 20MG BASE TABLET / ORAL AB 2005-04-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077045-003 CITALOPRAM HYDROBROMIDE EQ 10MG BASE TABLET / ORAL AB 2005-04-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077045-001 CITALOPRAM HYDROBROMIDE EQ 40MG BASE TABLET / ORAL AB 2005-04-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077045-002 CITALOPRAM HYDROBROMIDE EQ 20MG BASE TABLET / ORAL AB 2005-04-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077045-003 CITALOPRAM HYDROBROMIDE EQ 10MG BASE TABLET / ORAL AB 2005-04-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077045-001 CITALOPRAM HYDROBROMIDE EQ 40MG BASE TABLET / ORAL AB 2005-04-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077045-002 CITALOPRAM HYDROBROMIDE EQ 20MG BASE TABLET / ORAL AB 2005-04-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077045-003 CITALOPRAM HYDROBROMIDE EQ 10MG BASE TABLET / ORAL AB 2005-04-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077045-001 CITALOPRAM HYDROBROMIDE EQ 40MG BASE TABLET / ORAL AB 2005-04-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077045-002 CITALOPRAM HYDROBROMIDE EQ 20MG BASE TABLET / ORAL AB 2005-04-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077045-003 CITALOPRAM HYDROBROMIDE EQ 10MG BASE TABLET / ORAL AB 2005-04-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077045-001 CITALOPRAM HYDROBROMIDE EQ 40MG BASE TABLET / ORAL AB 2005-04-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077045-002 CITALOPRAM HYDROBROMIDE EQ 20MG BASE TABLET / ORAL AB 2005-04-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077045-003 CITALOPRAM HYDROBROMIDE EQ 10MG BASE TABLET / ORAL AB 2005-04-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077045-001 CITALOPRAM HYDROBROMIDE EQ 40MG BASE TABLET / ORAL AB 2005-04-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077045-002 CITALOPRAM HYDROBROMIDE EQ 20MG BASE TABLET / ORAL AB 2005-04-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077045-003 CITALOPRAM HYDROBROMIDE EQ 10MG BASE TABLET / ORAL AB 2005-04-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077045-001 CITALOPRAM HYDROBROMIDE EQ 40MG BASE TABLET / ORAL AB 2005-04-29 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077045-002 CITALOPRAM HYDROBROMIDE EQ 20MG BASE TABLET / ORAL AB 2005-04-29 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077045-003 CITALOPRAM HYDROBROMIDE EQ 10MG BASE TABLET / ORAL AB 2005-04-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077045-001 CITALOPRAM HYDROBROMIDE EQ 40MG BASE TABLET / ORAL AB 2005-04-29 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 4 of 4 · 129 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 43353-778-15 Citalopram 15 in 1 BOTTLE TABLET, FILM COATED 15 2 43353-778-45 Citalopram 45 in 1 BOTTLE TABLET, FILM COATED 45 2 43353-778-60 Citalopram 90 in 1 BOTTLE TABLET, FILM COATED 90 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43353-778 CITALOPRAM TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 Legacy NDC, 3 package rows 20190227_2fae4dd4-e4ca-4237-aab8-4079856d6bb0.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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join CITALOPRAM CITALOPRAM Golden State Medical Supply, Inc. f3a26d92-b662-4896-82eb-261948042408 2025-01-14 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 077045 application number: ANDA077045 CITALOPRAM CITALOPRAM Epic Pharma, LLC 08b6d5da-5919-4760-9e16-3b478a14d6d7 2024-09-18 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 077045 application number: ANDA077045 Citalopram CITALOPRAM Aphena Pharma Solutions - Tennessee, LLC 3d70380f-ef97-4de9-a8f8-44ef9ba7e5a7 2020-05-13 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 077045 application number: ANDA077045
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 43353-778-15 43353077815 15 in 1 BOTTLE Historical 43353-778-45 43353077845 45 in 1 BOTTLE Historical 43353-778-60 43353077860 90 in 1 BOTTLE Historical