Home NDC 71610-422 Citalopram
Product NDC 71610-422
11-digit product format 716100422
Labeler code 71610
Product ID 71610-422_5b7791df-471c-4407-a795-ad43aba3142d
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
Substance CITALOPRAM HYDROBROMIDE
Active strength 40 mg/1
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 · 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 · 123 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 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…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077045-002 CITALOPRAM HYDROBROMIDE EQ 20MG BASE TABLET / ORAL AB 2005-04-29 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077045-003 CITALOPRAM HYDROBROMIDE EQ 10MG BASE TABLET / ORAL AB 2005-04-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077045-001 CITALOPRAM HYDROBROMIDE EQ 40MG BASE TABLET / ORAL AB 2005-04-29 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077045-002 CITALOPRAM HYDROBROMIDE EQ 20MG BASE TABLET / ORAL AB 2005-04-29 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077045-003 CITALOPRAM HYDROBROMIDE EQ 10MG BASE TABLET / ORAL AB 2005-04-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077045-001 CITALOPRAM HYDROBROMIDE EQ 40MG BASE TABLET / ORAL AB 2005-04-29 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Citalopram
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CITALOPRAM HYDROBROMIDE 40 mg/1
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 309314 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 71610-422-45 Citalopram 45 in 1 BOTTLE TABLET, FILM COATED 45 1 71610-422-60 Citalopram 90 in 1 BOTTLE TABLET, FILM COATED 90 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71610-422 CITALOPRAM TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 Current NDC, Legacy NDC, 2 package rows 20200527_3d70380f-ef97-4de9-a8f8-44ef9ba7e5a7.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 ndc (product): 71610-422
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 71610-422-45 71610042245 45 TABLET, FILM COATED in 1 BOTTLE (71610-422-45) 2020-05-01 0000-00-00 No No Current 71610-422-60 71610042260 90 TABLET, FILM COATED in 1 BOTTLE (71610-422-60) 2020-05-18 0000-00-00 No No Current