Citalopram

Product NDC
42708-019
11-digit product format
427080019
Labeler code
42708
Product ID
42708-019_45866b17-f905-ad71-e063-6394a90a9455
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Citalopram Hydrobromide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
QPharma, Inc.
Application
ANDA077031
Marketing category
ANDA
Marketing start
2004-10-28
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077031-001CITALOPRAM HYDROBROMIDECITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2004-10-28
A077031-002CITALOPRAM HYDROBROMIDECITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2004-10-28
A077031-003CITALOPRAM HYDROBROMIDECITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2004-10-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A077031-001AB
A077031-002AB
A077031-003AB

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 UTC2026-02A077031-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2004-10-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077031-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2004-10-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077031-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2004-10-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077031-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2004-10-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077031-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2004-10-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077031-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2004-10-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A077031-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2004-10-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077031-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2004-10-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077031-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2004-10-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077031-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2004-10-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077031-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2004-10-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077031-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2004-10-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077031-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2004-10-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077031-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2004-10-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077031-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2004-10-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077031-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2004-10-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077031-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2004-10-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077031-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2004-10-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077031-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2004-10-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077031-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2004-10-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077031-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2004-10-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077031-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2004-10-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077031-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2004-10-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077031-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2004-10-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077031-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2004-10-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077031-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2004-10-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077031-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2004-10-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077031-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2004-10-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A077031-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2004-10-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A077031-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2004-10-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077031-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2004-10-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077031-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2004-10-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077031-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2004-10-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077031-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2004-10-28301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077031-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2004-10-28301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077031-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2004-10-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077031-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2004-10-281e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077031-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2004-10-281e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077031-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2004-10-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077031-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2004-10-288072bd15b7f6…

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 UTC2026-02A077031-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077031-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077031-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077031-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077031-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077031-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077031-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077031-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077031-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077031-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077031-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077031-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077031-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077031-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077031-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077031-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077031-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077031-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077031-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077031-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077031-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077031-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077031-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077031-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077031-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077031-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077031-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077031-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077031-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077031-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077031-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077031-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077031-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077031-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077031-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077031-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077031-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077031-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077031-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077031-001AB18072bd15b7f6…

Additional Listing Data#

Finished product
Yes
Brand name base
Citalopram
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CITALOPRAM HYDROBROMIDE20 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
200371Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
0a967468-3869-4c8c-849f-9fc3a8dcc489Available 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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42708-019-30Citalopram30 in 1 BOTTLETABLET, FILM COATED308

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42708-019CITALOPRAM (CITALOPRAM HYDROBROMIDE) TABLET, FILM COATED [QPHARMA, INC.]7Current NDC, Legacy NDC, 1 package rows20250521_0a967468-3869-4c8c-849f-9fc3a8dcc489.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 · 19 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CitalopramCITALOPRAM HYDROBROMIDEREMEDYREPACK INC.625a78b2-4751-4ca5-91b6-7c85fd9f8c2e2026-03-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077031
application number: ANDA077031
CitalopramCITALOPRAM HYDROBROMIDENorthwind Health Company, LLCd9cc1649-913d-832d-e053-2995a90a5f9a2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077031
application number: ANDA077031
CitalopramCITALOPRAM HYDROBROMIDENorthwind Health Company, LLCd9ccb3fb-b607-9491-e053-2995a90a39c92026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077031
application number: ANDA077031
CitalopramCITALOPRAM HYDROBROMIDEQPharma, Inc.0a967468-3869-4c8c-849f-9fc3a8dcc4892025-12-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077031
application number: ANDA077031
ndc (product): 42708-019
CitalopramCITALOPRAM HYDROBROMIDEPD-Rx Pharmaceuticals, Inc.31a18cdf-b0aa-18f5-e054-00144ff8d46c2025-10-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077031
application number: ANDA077031
CitalopramCITALOPRAM HYDROBROMIDENuCare Pharmaceuticals,Inc.544ba802-a536-579a-e054-00144ff88e882025-06-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077031
application number: ANDA077031
CitalopramCITALOPRAM HYDROBROMIDEBryant Ranch Prepack0bc0e09e-0f1d-4d52-b8fe-3ef8a2e5ea522025-06-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077031
application number: ANDA077031
CitalopramCITALOPRAM HYDROBROMIDEREMEDYREPACK INC.0109f365-bebd-4810-a56f-4451e10245db2025-04-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077031
application number: ANDA077031
Citalopram HydrobromideCITALOPRAM HYDROBROMIDEAdvanced Rx Pharmacy of Tennessee, LLCf8b06b55-f6a2-2438-e053-6394a90a530a2024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077031
application number: ANDA077031
CitalopramCITALOPRAM HYDROBROMIDEA-S Medication Solutions2500cc9d-a67d-46c5-9a76-99bc63959d672024-10-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077031
application number: ANDA077031
CitalopramCITALOPRAM HYDROBROMIDEA-S Medication Solutionsb244d4eb-8311-4663-8bca-dc08e88e5f5d2024-08-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077031
application number: ANDA077031
CitalopramCITALOPRAM HYDROBROMIDEQUALLENT PHARMACEUTICALS HEALTH LLCe0822069-9672-4d4c-bc1a-8739b0dd045c2024-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077031
application number: ANDA077031
CitalopramCITALOPRAM HYDROBROMIDEAurobindo Pharma Limited2632b547-2e13-447f-ac85-c774e437d6a82024-05-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077031
application number: ANDA077031
CitalopramCITALOPRAM HYDROBROMIDEA-S Medication Solutionsfc766b76-18c1-42cd-b276-f720f5821c112024-04-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077031
application number: ANDA077031
CitalopramCITALOPRAM HYDROBROMIDEA-S Medication Solutionsc6730edc-7226-4521-a04a-1bf296b01b8d2024-02-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077031
application number: ANDA077031
CitalopramCITALOPRAM HYDROBROMIDENCS HealthCare of KY, LLC dba Vangard Labsfd761647-e16b-45b3-a4bc-364de0ed70152023-09-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077031
application number: ANDA077031
CitalopramCITALOPRAM HYDROBROMIDEProficient Rx LPf37cc307-8b7d-4e5c-8beb-cd8779bc86a72022-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077031
application number: ANDA077031
CitalopramCITALOPRAM HYDROBROMIDEAphena Pharma Solutions - Tennessee, LLC31ddd184-7560-473c-b674-5fa3187c55982020-04-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077031
application number: ANDA077031
CitalopramCITALOPRAM HYDROBROMIDEProficient Rx LP289c1d5e-902f-47db-85b8-5e1a55ec86842019-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077031
application number: ANDA077031

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200371citalopram 20 MG Oral TabletPSN0a967468-3869-4c8c-849f-9fc3a8dcc4898
200371citalopram 20 MG Oral TabletSCD0a967468-3869-4c8c-849f-9fc3a8dcc4898
200371citalopram 20 MG (as citalopram HBr 24.99 MG) Oral TabletSY0a967468-3869-4c8c-849f-9fc3a8dcc4898

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
42708-019-304270800193030 TABLET, FILM COATED in 1 BOTTLE (42708-019-30) 2018-03-140000-00-00YesNoCurrent