Home NDC 42806-020 CITALOPRAM
Product NDC 42806-020
11-digit product format 428060020
Labeler code 42806
Product ID 42806-020_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 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 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.
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 2026-08-01 22:54:32 2026-06 A077045-001 CITALOPRAM HYDROBROMIDE EQ 40MG BASE TABLET / ORAL AB 2005-04-29 a50c72e98297…2026-08-01 22:54:32 2026-06 A077045-002 CITALOPRAM HYDROBROMIDE EQ 20MG BASE TABLET / ORAL AB 2005-04-29 a50c72e98297…2026-08-01 22:54:32 2026-06 A077045-003 CITALOPRAM HYDROBROMIDE EQ 10MG BASE TABLET / ORAL AB 2005-04-29 a50c72e98297…
Observed Orange Book normalized TE history# openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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): 42806-020 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
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 · 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 42806-020-01 CITALOPRAM 100 in 1 BOTTLE TABLET, FILM COATED 100 15 42806-020-05 CITALOPRAM 500 in 1 BOTTLE TABLET, FILM COATED 500 15 42806-020-10 CITALOPRAM 1000 in 1 BOTTLE TABLET, FILM COATED 1000 15 42806-020-30 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, FILM COATED [BLENHEIM PHARMACAL, INC.] 4 CITALOPRAM ACTIVE MOIETY 0DHU5B8D6V CITALOPRAM TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] 4 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK CITALOPRAM TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] 4 HYPROMELLOSE 2208 (100 MPA.S) INACTIVE INGREDIENT B1QE5P712K CITALOPRAM TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] 4 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X CITALOPRAM TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] 4 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CITALOPRAM TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] 4 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ CITALOPRAM TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] 4 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H CITALOPRAM TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] 4 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 CITALOPRAM TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] 4 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ CITALOPRAM TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] 4 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP CITALOPRAM TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] 4 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 42806-020 CITALOPRAM TABLET, FILM COATED [EPIC PHARMA, LLC] 15 Current NDC, Legacy NDC, 4 package rows 20241222_08b6d5da-5919-4760-9e16-3b478a14d6d7.zip
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 42806-020-01 42806002001 100 TABLET, FILM COATED in 1 BOTTLE (42806-020-01) 2011-05-20 0000-00-00 No No Current 42806-020-05 42806002005 500 in 1 BOTTLE Historical 42806-020-10 42806002010 1000 TABLET, FILM COATED in 1 BOTTLE (42806-020-10) 2011-05-20 0000-00-00 No No Current 42806-020-30 42806002030 30 TABLET, FILM COATED in 1 BOTTLE (42806-020-30) 2011-05-20 0000-00-00 No No Current