Home NDC 42806-019 CITALOPRAM
Product NDC 42806-019
11-digit product format 428060019
Labeler code 42806
Product ID 42806-019_b7f54932-2c8c-44f4-acc6-d9e2b3914be9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name citalopram
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Epic Pharma, LLC
Application ANDA077045
Marketing category ANDA
Marketing start 2011-05-20
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 2026-12-31
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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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 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 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 200371 Internal RxNorm lookup 283672 Internal RxNorm lookup 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 42806-019-01 CITALOPRAM 100 in 1 BOTTLE TABLET, FILM COATED 100 15 42806-019-05 CITALOPRAM 500 in 1 BOTTLE TABLET, FILM COATED 500 15 42806-019-10 CITALOPRAM 1000 in 1 BOTTLE TABLET, FILM COATED 1000 15 42806-019-30 CITALOPRAM 30 in 1 BOTTLE TABLET, FILM COATED 30 15
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CITALOPRAM HYDROBROMIDE ACTIVE INGREDIENT I1E9D14F36 CITALOPRAM TABLET, FILM COATED [EPIC PHARMA, LLC] 7 CITALOPRAM ACTIVE MOIETY 0DHU5B8D6V CITALOPRAM TABLET, FILM COATED [EPIC PHARMA, LLC] 7 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK CITALOPRAM TABLET, FILM COATED [EPIC PHARMA, LLC] 7 HYPROMELLOSE 2208 (100 MPA.S) INACTIVE INGREDIENT B1QE5P712K CITALOPRAM TABLET, FILM COATED [EPIC PHARMA, LLC] 7 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X CITALOPRAM TABLET, FILM COATED [EPIC PHARMA, LLC] 7 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CITALOPRAM TABLET, FILM COATED [EPIC PHARMA, LLC] 7 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ CITALOPRAM TABLET, FILM COATED [EPIC PHARMA, LLC] 7 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H CITALOPRAM TABLET, FILM COATED [EPIC PHARMA, LLC] 7 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 CITALOPRAM TABLET, FILM COATED [EPIC PHARMA, LLC] 7 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ CITALOPRAM TABLET, FILM COATED [EPIC PHARMA, LLC] 7 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP CITALOPRAM TABLET, FILM COATED [EPIC PHARMA, LLC] 7 CITALOPRAM HYDROBROMIDE ACTIVE INGREDIENT I1E9D14F36 CITALOPRAM TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 CITALOPRAM ACTIVE MOIETY 0DHU5B8D6V CITALOPRAM TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42806-019 CITALOPRAM TABLET, FILM COATED [EPIC PHARMA, LLC] 15 Current NDC, Legacy NDC, 4 package rows 20241222_08b6d5da-5919-4760-9e16-3b478a14d6d7.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 ndc (product): 42806-019 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 Marketing start Marketing end Sample Exclude flag Status 42806-019-01 42806001901 100 TABLET, FILM COATED in 1 BOTTLE (42806-019-01) 2011-05-20 0000-00-00 No No Current 42806-019-05 42806001905 500 in 1 BOTTLE Historical 42806-019-10 42806001910 1000 TABLET, FILM COATED in 1 BOTTLE (42806-019-10) 2011-05-20 0000-00-00 No No Current 42806-019-30 42806001930 30 TABLET, FILM COATED in 1 BOTTLE (42806-019-30) 2011-05-20 0000-00-00 No No Current