Citalopram

Product NDC
70518-2601
Requested package NDC
70518-2601-1
11-digit product format
705182601
Labeler code
70518
Product ID
70518-2601_4a69e716-1140-5ce8-e063-6394a90a57eb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
citalopram
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA077042
Marketing category
ANDA
Marketing start
2020-02-26
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 · 11 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077042-001CITALOPRAM HYDROBROMIDECITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2004-11-05
A077042-002CITALOPRAM HYDROBROMIDECITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2004-11-05
A077042-003CITALOPRAM HYDROBROMIDECITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2004-11-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A077042-001AB
A077042-002AB
A077042-003AB

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 UTC2026-02A077042-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2004-11-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077042-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2004-11-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077042-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2004-11-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077042-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2004-11-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077042-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2004-11-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077042-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2004-11-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A077042-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2004-11-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077042-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2004-11-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077042-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2004-11-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077042-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2004-11-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077042-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2004-11-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077042-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2004-11-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077042-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2004-11-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077042-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2004-11-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077042-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2004-11-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077042-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2004-11-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077042-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2004-11-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077042-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2004-11-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077042-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2004-11-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077042-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2004-11-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077042-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2004-11-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077042-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2004-11-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077042-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2004-11-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077042-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2004-11-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077042-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2004-11-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077042-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2004-11-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077042-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2004-11-05d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077042-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2004-11-05d06236e962d9…
2024-10-29 15:01 UTC2024-10A077042-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2004-11-05d06236e962d9…
2024-10-29 15:01 UTC2024-10A077042-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2004-11-05d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077042-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2004-11-0579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077042-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2004-11-0579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077042-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2004-11-0579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077042-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2004-11-05301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077042-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2004-11-05301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077042-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2004-11-05301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077042-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2004-11-051e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077042-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2004-11-051e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077042-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2004-11-051e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077042-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2004-11-058072bd15b7f6…

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 UTC2026-02A077042-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077042-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077042-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077042-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077042-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077042-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077042-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077042-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077042-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077042-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077042-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077042-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077042-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077042-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077042-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077042-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077042-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077042-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077042-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077042-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077042-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077042-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077042-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077042-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077042-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077042-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077042-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077042-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077042-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077042-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077042-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077042-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077042-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077042-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077042-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077042-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077042-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077042-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077042-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077042-001AB18072bd15b7f6…

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
aa9c1440-354f-43a6-9e70-fd7bafcb03c5Available 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
70518-2601-02022-01-31These highlights do not include all the information needed to use CITALOPRAM TABLETS safely and effectively. See full prescribing information for CITALOPRAM TABLETS . CITALOPRAM tablets, for oral use Initial U.S. Approval: 1998
70518-2601-02022-01-31These highlights do not include all the information needed to use CITALOPRAM TABLETS safely and effectively. See full prescribing information for CITALOPRAM TABLETS . CITALOPRAM tablets, for oral use Initial U.S. Approval: 1998
70518-2601-02022-01-31These highlights do not include all the information needed to use CITALOPRAM TABLETS safely and effectively. See full prescribing information for CITALOPRAM TABLETS . CITALOPRAM tablets, for oral use Initial U.S. Approval: 1998
70518-2601-12022-01-31These highlights do not include all the information needed to use CITALOPRAM TABLETS safely and effectively. See full prescribing information for CITALOPRAM TABLETS . CITALOPRAM tablets, for oral use Initial U.S. Approval: 1998
70518-2601-12022-01-31These highlights do not include all the information needed to use CITALOPRAM TABLETS safely and effectively. See full prescribing information for CITALOPRAM TABLETS . CITALOPRAM tablets, for oral use Initial U.S. Approval: 1998
70518-2601-12022-01-31These highlights do not include all the information needed to use CITALOPRAM TABLETS safely and effectively. See full prescribing information for CITALOPRAM TABLETS . CITALOPRAM tablets, for oral use Initial U.S. Approval: 1998
70518-2601-02022-01-28These highlights do not include all the information needed to use CITALOPRAM TABLETS safely and effectively. See full prescribing information for CITALOPRAM TABLETS . CITALOPRAM tablets, for oral use Initial U.S. Approval: 1998
70518-2601-02022-01-28These highlights do not include all the information needed to use CITALOPRAM TABLETS safely and effectively. See full prescribing information for CITALOPRAM TABLETS . CITALOPRAM tablets, for oral use Initial U.S. Approval: 1998
70518-2601-02022-01-28These highlights do not include all the information needed to use CITALOPRAM TABLETS safely and effectively. See full prescribing information for CITALOPRAM TABLETS . CITALOPRAM tablets, for oral use Initial U.S. Approval: 1998
70518-2601-12022-01-28These highlights do not include all the information needed to use CITALOPRAM TABLETS safely and effectively. See full prescribing information for CITALOPRAM TABLETS . CITALOPRAM tablets, for oral use Initial U.S. Approval: 1998
70518-2601-12022-01-28These highlights do not include all the information needed to use CITALOPRAM TABLETS safely and effectively. See full prescribing information for CITALOPRAM TABLETS . CITALOPRAM tablets, for oral use Initial U.S. Approval: 1998
70518-2601-12022-01-28These highlights do not include all the information needed to use CITALOPRAM TABLETS safely and effectively. See full prescribing information for CITALOPRAM TABLETS . CITALOPRAM tablets, for oral use Initial U.S. Approval: 1998

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-2601-0Citalopram90 in 1 BOTTLE, PLASTICTABLET, FILM COATED9014
70518-2601-1Citalopram100 in 1 BOXTABLET, FILM COATED10014
70518-2601-2Citalopram1 in 1 POUCHTABLET, FILM COATED114
70518-2601-3Citalopram30 in 1 BLISTER PACKTABLET, FILM COATED3014

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2601CITALOPRAM TABLET, FILM COATED [REMEDYREPACK INC.]11Current NDC, Legacy NDC, 4 package rows20250322_aa9c1440-354f-43a6-9e70-fd7bafcb03c5.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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CitalopramCITALOPRAMREMEDYREPACK INC.f79f878e-99fb-4757-8abb-931af1fa9e2b2026-07-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077042
application number: ANDA077042
CitalopramCITALOPRAMREMEDYREPACK INC.aa9c1440-354f-43a6-9e70-fd7bafcb03c52026-07-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077042
application number: ANDA077042
ndc (package): 70518-2601-1
ndc (product): 70518-2601
ndc11 (package): 70518260101
CitalopramCITALOPRAMBryant Ranch Prepack2a8acad8-0ba0-4631-9f6d-f587e7a8558c2024-10-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077042
application number: ANDA077042
CitalopramCITALOPRAMMylan Pharmaceuticals Inc.825c0c49-5fbf-6d8b-cb8c-94ebf0eda0432024-06-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077042
application number: ANDA077042
CitalopramCITALOPRAMNuCare Pharmaceuticals,Inc.0dfb11d9-f48d-56ee-e063-6294a90ad2562024-01-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077042
application number: ANDA077042

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309314citalopram 40 MG Oral TabletPSNaa9c1440-354f-43a6-9e70-fd7bafcb03c514
309314citalopram 40 MG Oral TabletSCDaa9c1440-354f-43a6-9e70-fd7bafcb03c514
309314citalopram 40 MG (as citalopram HBr 49.98 MG) Oral TabletSYaa9c1440-354f-43a6-9e70-fd7bafcb03c514

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-2601-170518260101100 POUCH in 1 BOX (70518-2601-1) / 1 TABLET, FILM COATED in 1 POUCH (70518-2601-2) 100 pouch2020-04-160000-00-00NoNoCurrent