Citalopram

Product NDC
70518-2228
Requested package NDC
70518-2228-0
11-digit product format
705182228
Labeler code
70518
Product ID
70518-2228_4ba688dd-17ac-975f-e063-6394a90aef14
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Citalopram
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA077534
Marketing category
ANDA
Marketing start
2019-07-13
Substance
CITALOPRAM HYDROBROMIDE
Active strength
40 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 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70518-222870518-2228-0DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70518-222870518-2228-0DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077534-001CITALOPRAM HYDROBROMIDECITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2006-10-03
A077534-002CITALOPRAM HYDROBROMIDECITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2006-10-03
A077534-003CITALOPRAM HYDROBROMIDECITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2006-10-03

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A077534-001AB
A077534-002AB
A077534-003AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A077534-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2006-10-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077534-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2006-10-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077534-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2006-10-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077534-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2006-10-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077534-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2006-10-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077534-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2006-10-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08A077534-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2006-10-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077534-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2006-10-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077534-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2006-10-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077534-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2006-10-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077534-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2006-10-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077534-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2006-10-03fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077534-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2006-10-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077534-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2006-10-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077534-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2006-10-03b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077534-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2006-10-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077534-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2006-10-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077534-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2006-10-0303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077534-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2006-10-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077534-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2006-10-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077534-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2006-10-032680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077534-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2006-10-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077534-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2006-10-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077534-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2006-10-035bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077534-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2006-10-03d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077534-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2006-10-03d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077534-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2006-10-03d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077534-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2006-10-03d06236e962d9…
2024-10-29 15:01 UTC2024-10A077534-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2006-10-03d06236e962d9…
2024-10-29 15:01 UTC2024-10A077534-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2006-10-03d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077534-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2006-10-0379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077534-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2006-10-0379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077534-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2006-10-0379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077534-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2006-10-03301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077534-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2006-10-03301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077534-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2006-10-03301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077534-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2006-10-031e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077534-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2006-10-031e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077534-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2006-10-031e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077534-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2006-10-038072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A077534-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077534-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077534-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077534-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077534-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077534-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077534-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077534-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077534-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077534-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077534-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077534-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077534-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077534-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077534-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077534-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077534-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077534-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077534-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077534-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077534-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077534-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077534-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077534-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077534-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077534-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077534-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077534-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077534-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077534-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077534-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077534-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077534-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077534-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077534-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077534-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077534-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077534-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077534-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077534-001AB18072bd15b7f6…

Additional Listing Data#

Finished product
Yes
Brand name base
Citalopram
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CITALOPRAM HYDROBROMIDE40 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
I1E9D14F36Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
309314Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
c9809dfe-939e-4f9d-b6dd-f9808fd9f2b1Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
475812f9-1b2c-4cb0-9e72-1e52f935ae6fProduct name120221114
0b05d650-9b7b-4b36-a6f4-1a850d5a2e64Product name120151228
e61ea6cb-0b08-40a9-a984-7b23201c7aa2Product name120151222

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-2228-0Citalopram30 in 1 BLISTER PACKTABLET3018
70518-2228-1Citalopram90 in 1 BOTTLE, PLASTICTABLET9018
70518-2228-2Citalopram30 in 1 BOTTLE, PLASTICTABLET3018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70518-2228-1EA - Each70518-22286bc3bb30-b1d5-4041-8925-b7fd5c5d3f7312026-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2228CITALOPRAM TABLET [REMEDYREPACK INC.]11Current NDC, Legacy NDC, 3 package rows20250309_c9809dfe-939e-4f9d-b6dd-f9808fd9f2b1.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 · 13 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CitalopramCITALOPRAMREMEDYREPACK INC.c9809dfe-939e-4f9d-b6dd-f9808fd9f2b12026-07-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077534
application number: ANDA077534
ndc (package): 70518-2228-0
ndc (product): 70518-2228
ndc11 (package): 70518222800
CitalopramCITALOPRAMREMEDYREPACK INC.25b0d184-2a4c-42b0-9a57-7a00fa3e0cd72026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077534
application number: ANDA077534
CITALOPRAM HYDROBROMIDECITALOPRAMAphena Pharma Solutions - Tennessee, LLC7307df53-d570-4e26-971d-e97522ccce7f2026-03-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077534
application number: ANDA077534
CitalopramCITALOPRAMNorthwind Health Company, LLCf2b42bdc-47e0-19c5-e053-2a95a90a18282026-01-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077534
application number: ANDA077534
CitalopramCITALOPRAMNorthwind Health Company, LLCf2b54f10-221f-5eed-e053-2995a90ab47f2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077534
application number: ANDA077534
CitalopramCITALOPRAMNorthwind Health Company, LLCf77ef23b-3015-d074-e053-6394a90a11e12026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077534
application number: ANDA077534
CitalopramCITALOPRAMCipla USA Inc.0580559a-783a-4a0a-8d81-ee30a29077c52024-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077534
application number: ANDA077534
CITALOPRAM HYDROBROMIDECITALOPRAMExelan Pharmaceuticals Inc.a8e8fde2-8392-4d5b-902b-e2b9dd55a02d2024-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077534
application number: ANDA077534
CitalopramCITALOPRAMA-S Medication Solutionsc91684c7-fddb-4cf0-9711-b0484c8c7e8b2024-04-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077534
application number: ANDA077534
CitalopramCITALOPRAMA-S Medication Solutions17af7a8d-ef57-4253-96ed-e457e0062eb52024-04-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077534
application number: ANDA077534
CitalopramCITALOPRAMA-S Medication Solutions04ac5286-fc2e-4990-a574-ea21131ef7312024-04-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077534
application number: ANDA077534
CitalopramCITALOPRAMAphena Pharma Solutions - Tennessee, LLC0867140e-a483-4bf7-8326-4a9730cc9d9d2020-04-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077534
application number: ANDA077534
CITALOPRAM HYDROBROMIDECITALOPRAMAphena Pharma Solutions - Tennessee, LLCd05f4e71-95f3-4f22-8b01-b21e5c19e0f22018-07-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077534
application number: ANDA077534

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309314citalopram 40 MG Oral TabletPSNc9809dfe-939e-4f9d-b6dd-f9808fd9f2b118
309314citalopram 40 MG Oral TabletSCDc9809dfe-939e-4f9d-b6dd-f9808fd9f2b118
309314citalopram 40 MG (as citalopram HBr 49.98 MG) Oral TabletSYc9809dfe-939e-4f9d-b6dd-f9808fd9f2b118

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-2228-07051822280030 TABLET in 1 BLISTER PACK (70518-2228-0) 30 tablet2019-07-130000-00-00NoNoCurrent