Home NDC 68071-3558 Citalopram
Product NDC 68071-3558
11-digit product format 680713558
Labeler code 68071
Product ID 68071-3558_0dfb11d9-f48e-56ee-e063-6294a90ad256
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name citalopram
Dosage form TABLET, FILM COATED
Route ORAL
Labeler NuCare Pharmaceuticals,Inc.
Application ANDA077042
Marketing category ANDA
Marketing start 2008-07-28
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 A077042-001 CITALOPRAM HYDROBROMIDE CITALOPRAM HYDROBROMIDE EQ 10MG BASE TABLET / ORAL AB 2004-11-05 A077042-002 CITALOPRAM HYDROBROMIDE CITALOPRAM HYDROBROMIDE EQ 20MG BASE TABLET / ORAL AB 2004-11-05 A077042-003 CITALOPRAM HYDROBROMIDE CITALOPRAM HYDROBROMIDE EQ 40MG BASE TABLET / ORAL AB 2004-11-05
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 A077042-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE TABLET / ORAL AB 2004-11-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077042-002 CITALOPRAM HYDROBROMIDE EQ 20MG BASE TABLET / ORAL AB 2004-11-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077042-003 CITALOPRAM HYDROBROMIDE EQ 40MG BASE TABLET / ORAL AB 2004-11-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077042-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE TABLET / ORAL AB 2004-11-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077042-002 CITALOPRAM HYDROBROMIDE EQ 20MG BASE TABLET / ORAL AB 2004-11-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077042-003 CITALOPRAM HYDROBROMIDE EQ 40MG BASE TABLET / ORAL AB 2004-11-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077042-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE TABLET / ORAL AB 2004-11-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077042-002 CITALOPRAM HYDROBROMIDE EQ 20MG BASE TABLET / ORAL AB 2004-11-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077042-003 CITALOPRAM HYDROBROMIDE EQ 40MG BASE TABLET / ORAL AB 2004-11-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077042-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE TABLET / ORAL AB 2004-11-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077042-002 CITALOPRAM HYDROBROMIDE EQ 20MG BASE TABLET / ORAL AB 2004-11-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077042-003 CITALOPRAM HYDROBROMIDE EQ 40MG BASE TABLET / ORAL AB 2004-11-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077042-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE TABLET / ORAL AB 2004-11-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077042-002 CITALOPRAM HYDROBROMIDE EQ 20MG BASE TABLET / ORAL AB 2004-11-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077042-003 CITALOPRAM HYDROBROMIDE EQ 40MG BASE TABLET / ORAL AB 2004-11-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077042-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE TABLET / ORAL AB 2004-11-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077042-002 CITALOPRAM HYDROBROMIDE EQ 20MG BASE TABLET / ORAL AB 2004-11-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077042-003 CITALOPRAM HYDROBROMIDE EQ 40MG BASE TABLET / ORAL AB 2004-11-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077042-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE TABLET / ORAL AB 2004-11-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077042-002 CITALOPRAM HYDROBROMIDE EQ 20MG BASE TABLET / ORAL AB 2004-11-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077042-003 CITALOPRAM HYDROBROMIDE EQ 40MG BASE TABLET / ORAL AB 2004-11-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077042-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE TABLET / ORAL AB 2004-11-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077042-002 CITALOPRAM HYDROBROMIDE EQ 20MG BASE TABLET / ORAL AB 2004-11-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077042-003 CITALOPRAM HYDROBROMIDE EQ 40MG BASE TABLET / ORAL AB 2004-11-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077042-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE TABLET / ORAL AB 2004-11-05 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077042-002 CITALOPRAM HYDROBROMIDE EQ 20MG BASE TABLET / ORAL AB 2004-11-05 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077042-003 CITALOPRAM HYDROBROMIDE EQ 40MG BASE TABLET / ORAL AB 2004-11-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077042-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE TABLET / ORAL AB 2004-11-05 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077042-002 CITALOPRAM HYDROBROMIDE EQ 20MG BASE TABLET / ORAL AB 2004-11-05 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077042-003 CITALOPRAM HYDROBROMIDE EQ 40MG BASE TABLET / ORAL AB 2004-11-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077042-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE TABLET / ORAL AB 2004-11-05 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077042-002 CITALOPRAM HYDROBROMIDE EQ 20MG BASE TABLET / ORAL AB 2004-11-05 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077042-003 CITALOPRAM HYDROBROMIDE EQ 40MG BASE TABLET / ORAL AB 2004-11-05 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077042-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE TABLET / ORAL AB 2004-11-05 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077042-002 CITALOPRAM HYDROBROMIDE EQ 20MG BASE TABLET / ORAL AB 2004-11-05 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077042-003 CITALOPRAM HYDROBROMIDE EQ 40MG BASE TABLET / ORAL AB 2004-11-05 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077042-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE TABLET / ORAL AB 2004-11-05 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077042-002 CITALOPRAM HYDROBROMIDE EQ 20MG BASE TABLET / ORAL AB 2004-11-05 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077042-003 CITALOPRAM HYDROBROMIDE EQ 40MG BASE TABLET / ORAL AB 2004-11-05 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077042-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE TABLET / ORAL AB 2004-11-05 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 68071-3558-1 Citalopram 100 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 100 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68071-3558 CITALOPRAM TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.] 1 Current NDC, 1 package rows 20240103_0dfb11d9-f48d-56ee-e063-6294a90ad256.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 · 5 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Citalopram CITALOPRAM REMEDYREPACK INC. f79f878e-99fb-4757-8abb-931af1fa9e2b 2026-07-27 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 077042 application number: ANDA077042 Citalopram CITALOPRAM REMEDYREPACK INC. aa9c1440-354f-43a6-9e70-fd7bafcb03c5 2026-07-27 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 077042 application number: ANDA077042 Citalopram CITALOPRAM Bryant Ranch Prepack 2a8acad8-0ba0-4631-9f6d-f587e7a8558c 2024-10-04 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 077042 application number: ANDA077042 Citalopram CITALOPRAM Mylan Pharmaceuticals Inc. 825c0c49-5fbf-6d8b-cb8c-94ebf0eda043 2024-06-23 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 077042 application number: ANDA077042 Citalopram CITALOPRAM NuCare Pharmaceuticals,Inc. 0dfb11d9-f48d-56ee-e063-6294a90ad256 2024-01-02 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 077042 application number: ANDA077042 ndc (product): 68071-3558
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 68071-3558-1 68071355801 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68071-3558-1) 2024-01-02 No No Current