Home NDC 70518-2553 Citalopram
Product NDC 70518-2553
11-digit product format 705182553
Labeler code 70518
Product ID 70518-2553_4a67aedb-35d4-e009-e063-6394a90a467c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name citalopram
Dosage form TABLET, FILM COATED
Route ORAL
Labeler REMEDYREPACK INC.
Application ANDA077042
Marketing category ANDA
Marketing start 2020-01-22
Substance CITALOPRAM HYDROBROMIDE
Active strength 10 mg/1
Pharmacologic classes Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes 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 1 · 14 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CITALOPRAM HYDROBROMIDE 10 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 283672 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 70518-2553-0 Citalopram 90 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 90 10 70518-2553-1 Citalopram 30 in 1 BLISTER PACK TABLET, FILM COATED 30 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70518-2553 CITALOPRAM TABLET, FILM COATED [REMEDYREPACK INC.] 8 Current NDC, Legacy NDC, 2 package rows 20250202_f79f878e-99fb-4757-8abb-931af1fa9e2b.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 ndc (product): 70518-2553 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
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 70518-2553-0 70518255300 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-2553-0) 2020-01-22 0000-00-00 No No Current 70518-2553-1 70518255301 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-2553-1) 2025-01-30 No No Current