Home NDC 65162-052 Citalopram
Product NDC 65162-052
11-digit product format 651620052
Labeler code 65162
Product ID 65162-052_a42ab6f8-0664-4d9d-9da0-116bba7e55fc
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Citalopram
Dosage form TABLET
Route ORAL
Labeler Amneal Pharmaceuticals LLC
Application ANDA077289
Marketing category ANDA
Marketing start 2010-04-06
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 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 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 65162-052-03 Citalopram 30 in 1 BOTTLE TABLET 30 30 65162-052-10 Citalopram 100 in 1 BOTTLE TABLET 100 30 65162-052-11 Citalopram 1000 in 1 BOTTLE TABLET 1000 30 65162-052-50 Citalopram 500 in 1 BOTTLE TABLET 500 30
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CITALOPRAM HYDROBROMIDE ACTIVE INGREDIENT I1E9D14F36 CITALOPRAM TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 17 CITALOPRAM ACTIVE MOIETY 0DHU5B8D6V CITALOPRAM TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 17 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U CITALOPRAM TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 17 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 CITALOPRAM TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 17 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT CITALOPRAM TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 17 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX CITALOPRAM TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 17 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X CITALOPRAM TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 17 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CITALOPRAM TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 17 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A CITALOPRAM TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 17 POLYVINYL ALCOHOL INACTIVE INGREDIENT 532B59J990 CITALOPRAM TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 17 POVIDONE K12 INACTIVE INGREDIENT 333AG72FWJ CITALOPRAM TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 17 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 CITALOPRAM TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 17 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ CITALOPRAM TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 17 TALC INACTIVE INGREDIENT 7SEV7J4R1U CITALOPRAM TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 17 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP CITALOPRAM TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 17 CITALOPRAM HYDROBROMIDE ACTIVE INGREDIENT I1E9D14F36 CITALOPRAM TABLET [APHENA PHARMA SOLUTIONS - NEW JERSEY, LLC] 1 CITALOPRAM HYDROBROMIDE ACTIVE INGREDIENT I1E9D14F36 CITALOPRAM TABLET [CONTRACT PHARMACY SERVICES-PA] 1 CITALOPRAM ACTIVE MOIETY 0DHU5B8D6V CITALOPRAM TABLET [APHENA PHARMA SOLUTIONS - NEW JERSEY, LLC] 1 CITALOPRAM ACTIVE MOIETY 0DHU5B8D6V CITALOPRAM TABLET [CONTRACT PHARMACY SERVICES-PA] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U CITALOPRAM TABLET [APHENA PHARMA SOLUTIONS - NEW JERSEY, LLC] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U CITALOPRAM TABLET [CONTRACT PHARMACY SERVICES-PA] 1 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 CITALOPRAM TABLET [CONTRACT PHARMACY SERVICES-PA] 1 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 CITALOPRAM TABLET [APHENA PHARMA SOLUTIONS - NEW JERSEY, LLC] 1 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT CITALOPRAM TABLET [APHENA PHARMA SOLUTIONS - NEW JERSEY, LLC] 1 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT CITALOPRAM TABLET [CONTRACT PHARMACY SERVICES-PA] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX CITALOPRAM TABLET [APHENA PHARMA SOLUTIONS - NEW JERSEY, LLC] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX CITALOPRAM TABLET [CONTRACT PHARMACY SERVICES-PA] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X CITALOPRAM TABLET [APHENA PHARMA SOLUTIONS - NEW JERSEY, LLC] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X CITALOPRAM TABLET [CONTRACT PHARMACY SERVICES-PA] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CITALOPRAM TABLET [CONTRACT PHARMACY SERVICES-PA] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CITALOPRAM TABLET [APHENA PHARMA SOLUTIONS - NEW JERSEY, LLC] 1 POLYETHYLENE GLYCOL INACTIVE INGREDIENT 3WJQ0SDW1A CITALOPRAM TABLET [CONTRACT PHARMACY SERVICES-PA] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A CITALOPRAM TABLET [APHENA PHARMA SOLUTIONS - NEW JERSEY, LLC] 1 POLYVINYL ALCOHOL INACTIVE INGREDIENT 532B59J990 CITALOPRAM TABLET [APHENA PHARMA SOLUTIONS - NEW JERSEY, LLC] 1 POLYVINYL ALCOHOL INACTIVE INGREDIENT 532B59J990 CITALOPRAM TABLET [CONTRACT PHARMACY SERVICES-PA] 1 POVIDONE K12 INACTIVE INGREDIENT 333AG72FWJ CITALOPRAM TABLET [APHENA PHARMA SOLUTIONS - NEW JERSEY, LLC] 1 POVIDONE K12 INACTIVE INGREDIENT 333AG72FWJ CITALOPRAM TABLET [CONTRACT PHARMACY SERVICES-PA] 1 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 CITALOPRAM TABLET [APHENA PHARMA SOLUTIONS - NEW JERSEY, LLC] 1 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 CITALOPRAM TABLET [CONTRACT PHARMACY SERVICES-PA] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ CITALOPRAM TABLET [CONTRACT PHARMACY SERVICES-PA] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ CITALOPRAM TABLET [APHENA PHARMA SOLUTIONS - NEW JERSEY, LLC] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U CITALOPRAM TABLET [APHENA PHARMA SOLUTIONS - NEW JERSEY, LLC] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U CITALOPRAM TABLET [CONTRACT PHARMACY SERVICES-PA] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP CITALOPRAM TABLET [APHENA PHARMA SOLUTIONS - NEW JERSEY, LLC] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP CITALOPRAM TABLET [CONTRACT PHARMACY SERVICES-PA] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65162-052 CITALOPRAM TABLET [AMNEAL PHARMACEUTICALS LLC] 30 Current NDC, Legacy NDC, 4 package rows 20240925_6a402640-1c9d-4fca-8b5b-e1ac1dd4ca5a.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 65162-052-03 65162005203 30 TABLET in 1 BOTTLE (65162-052-03) 30 tablet 2010-04-06 0000-00-00 No No Current 65162-052-10 65162005210 100 TABLET in 1 BOTTLE (65162-052-10) 100 tablet 2010-04-06 0000-00-00 No No Current 65162-052-11 65162005211 1000 TABLET in 1 BOTTLE (65162-052-11) 1000 tablet 2010-04-06 0000-00-00 No No Current 65162-052-50 65162005250 500 TABLET in 1 BOTTLE (65162-052-50) 500 tablet 2010-04-06 0000-00-00 No No Current