Home NDC 43063-063 Citalopram
Product NDC 43063-063
11-digit product format 430630063
Labeler code 43063
Product ID 43063-063_2b24d618-2b9f-f54e-e063-6394a90a9c46
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Citalopram
Dosage form TABLET
Route ORAL
Labeler PD-Rx Pharmaceuticals, Inc.
Application ANDA077289
Marketing category ANDA
Marketing start 2010-04-06
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 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 A077289-001 CITALOPRAM HYDROBROMIDE CITALOPRAM HYDROBROMIDE EQ 10MG BASE TABLET / ORAL 2006-11-30 A077289-002 CITALOPRAM HYDROBROMIDE CITALOPRAM HYDROBROMIDE EQ 20MG BASE TABLET / ORAL 2006-11-30 A077289-003 CITALOPRAM HYDROBROMIDE CITALOPRAM HYDROBROMIDE EQ 40MG BASE TABLET / ORAL 2006-11-30
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 A077289-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE TABLET / ORAL AB 2006-11-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077289-002 CITALOPRAM HYDROBROMIDE EQ 20MG BASE TABLET / ORAL AB 2006-11-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077289-003 CITALOPRAM HYDROBROMIDE EQ 40MG BASE TABLET / ORAL AB 2006-11-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077289-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE TABLET / ORAL AB 2006-11-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077289-002 CITALOPRAM HYDROBROMIDE EQ 20MG BASE TABLET / ORAL AB 2006-11-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077289-003 CITALOPRAM HYDROBROMIDE EQ 40MG BASE TABLET / ORAL AB 2006-11-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077289-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE TABLET / ORAL AB 2006-11-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077289-002 CITALOPRAM HYDROBROMIDE EQ 20MG BASE TABLET / ORAL AB 2006-11-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077289-003 CITALOPRAM HYDROBROMIDE EQ 40MG BASE TABLET / ORAL AB 2006-11-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077289-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE TABLET / ORAL AB 2006-11-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077289-002 CITALOPRAM HYDROBROMIDE EQ 20MG BASE TABLET / ORAL AB 2006-11-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077289-003 CITALOPRAM HYDROBROMIDE EQ 40MG BASE TABLET / ORAL AB 2006-11-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077289-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE TABLET / ORAL AB 2006-11-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077289-002 CITALOPRAM HYDROBROMIDE EQ 20MG BASE TABLET / ORAL AB 2006-11-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077289-003 CITALOPRAM HYDROBROMIDE EQ 40MG BASE TABLET / ORAL AB 2006-11-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077289-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE TABLET / ORAL AB 2006-11-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077289-002 CITALOPRAM HYDROBROMIDE EQ 20MG BASE TABLET / ORAL AB 2006-11-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077289-003 CITALOPRAM HYDROBROMIDE EQ 40MG BASE TABLET / ORAL AB 2006-11-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077289-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE TABLET / ORAL AB 2006-11-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077289-002 CITALOPRAM HYDROBROMIDE EQ 20MG BASE TABLET / ORAL AB 2006-11-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077289-003 CITALOPRAM HYDROBROMIDE EQ 40MG BASE TABLET / ORAL AB 2006-11-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077289-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE TABLET / ORAL AB 2006-11-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077289-002 CITALOPRAM HYDROBROMIDE EQ 20MG BASE TABLET / ORAL AB 2006-11-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077289-003 CITALOPRAM HYDROBROMIDE EQ 40MG BASE TABLET / ORAL AB 2006-11-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077289-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE TABLET / ORAL AB 2006-11-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077289-002 CITALOPRAM HYDROBROMIDE EQ 20MG BASE TABLET / ORAL AB 2006-11-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077289-003 CITALOPRAM HYDROBROMIDE EQ 40MG BASE TABLET / ORAL AB 2006-11-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077289-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE TABLET / ORAL AB 2006-11-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077289-002 CITALOPRAM HYDROBROMIDE EQ 20MG BASE TABLET / ORAL AB 2006-11-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077289-003 CITALOPRAM HYDROBROMIDE EQ 40MG BASE TABLET / ORAL AB 2006-11-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077289-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE TABLET / ORAL AB 2006-11-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077289-002 CITALOPRAM HYDROBROMIDE EQ 20MG BASE TABLET / ORAL AB 2006-11-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077289-003 CITALOPRAM HYDROBROMIDE EQ 40MG BASE TABLET / ORAL AB 2006-11-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077289-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE TABLET / ORAL AB 2006-11-30 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077289-002 CITALOPRAM HYDROBROMIDE EQ 20MG BASE TABLET / ORAL AB 2006-11-30 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077289-003 CITALOPRAM HYDROBROMIDE EQ 40MG BASE TABLET / ORAL AB 2006-11-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077289-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE TABLET / ORAL AB 2006-11-30 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077289-002 CITALOPRAM HYDROBROMIDE EQ 20MG BASE TABLET / ORAL AB 2006-11-30 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077289-003 CITALOPRAM HYDROBROMIDE EQ 40MG BASE TABLET / ORAL AB 2006-11-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077289-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE TABLET / ORAL AB 2006-11-30 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 120 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 20 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 200371 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 43063-063-14 Citalopram 14 in 1 BOTTLE, PLASTIC TABLET 14 29 43063-063-30 Citalopram 30 in 1 BOTTLE, PLASTIC TABLET 30 29 43063-063-60 Citalopram 60 in 1 BOTTLE, PLASTIC TABLET 60 29 43063-063-90 Citalopram 90 in 1 BOTTLE, PLASTIC TABLET 90 29
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CITALOPRAM HYDROBROMIDE ACTIVE INGREDIENT I1E9D14F36 CITALOPRAM TABLET [PD-RX PHARMACEUTICALS, INC.] 9 CITALOPRAM ACTIVE MOIETY 0DHU5B8D6V CITALOPRAM TABLET [PD-RX PHARMACEUTICALS, INC.] 9 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U CITALOPRAM TABLET [PD-RX PHARMACEUTICALS, INC.] 9 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 CITALOPRAM TABLET [PD-RX PHARMACEUTICALS, INC.] 9 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX CITALOPRAM TABLET [PD-RX PHARMACEUTICALS, INC.] 9 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X CITALOPRAM TABLET [PD-RX PHARMACEUTICALS, INC.] 9 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CITALOPRAM TABLET [PD-RX PHARMACEUTICALS, INC.] 9 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A CITALOPRAM TABLET [PD-RX PHARMACEUTICALS, INC.] 9 POLYVINYL ALCOHOL INACTIVE INGREDIENT 532B59J990 CITALOPRAM TABLET [PD-RX PHARMACEUTICALS, INC.] 9 POVIDONE K12 INACTIVE INGREDIENT 333AG72FWJ CITALOPRAM TABLET [PD-RX PHARMACEUTICALS, INC.] 9 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 CITALOPRAM TABLET [PD-RX PHARMACEUTICALS, INC.] 9 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ CITALOPRAM TABLET [PD-RX PHARMACEUTICALS, INC.] 9 TALC INACTIVE INGREDIENT 7SEV7J4R1U CITALOPRAM TABLET [PD-RX PHARMACEUTICALS, INC.] 9 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP CITALOPRAM TABLET [PD-RX PHARMACEUTICALS, INC.] 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43063-063 CITALOPRAM TABLET [PD-RX PHARMACEUTICALS, INC.] 29 Current NDC, Legacy NDC, 4 package rows 20250109_75f6db65-e4ed-470a-9e56-12791f22ee9b.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 43063-063-14 43063006314 14 TABLET in 1 BOTTLE, PLASTIC (43063-063-14) 14 tablet 2012-08-21 0000-00-00 No No Current 43063-063-30 43063006330 30 TABLET in 1 BOTTLE, PLASTIC (43063-063-30) 30 tablet 2012-08-21 0000-00-00 No No Current 43063-063-60 43063006360 60 TABLET in 1 BOTTLE, PLASTIC (43063-063-60) 60 tablet 2012-08-21 0000-00-00 No No Current 43063-063-90 43063006390 90 TABLET in 1 BOTTLE, PLASTIC (43063-063-90) 90 tablet 2012-08-21 0000-00-00 No No Current