Citalopram

Product NDC
71335-2232
11-digit product format
713352232
Labeler code
71335
Product ID
71335-2232_ff4ddb77-91cf-4e45-b855-55e4c264d085
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
citalopram
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA077042
Marketing category
ANDA
Marketing start
2008-07-28
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
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
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
2026-12-31

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
2a8acad8-0ba0-4631-9f6d-f587e7a8558cAvailable 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
71335-2232-1Citalopram30 in 1 BOTTLE, PLASTICTABLET, FILM COATED30102
71335-2232-2Citalopram40 in 1 BOTTLE, PLASTICTABLET, FILM COATED40102
71335-2232-3Citalopram60 in 1 BOTTLE, PLASTICTABLET, FILM COATED60102
71335-2232-4Citalopram90 in 1 BOTTLE, PLASTICTABLET, FILM COATED90102
71335-2232-5Citalopram100 in 1 BOTTLE, PLASTICTABLET, FILM COATED100102
71335-2232-6Citalopram180 in 1 BOTTLE, PLASTICTABLET, FILM COATED180102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2232-1EA - Each71335-2232360fd497-8042-45f5-9d91-32eb02883d5512025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2232CITALOPRAM TABLET, FILM COATED [BRYANT RANCH PREPACK]102Current NDC, 6 package rows20241019_2a8acad8-0ba0-4631-9f6d-f587e7a8558c.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
CitalopramCITALOPRAMBryant Ranch Prepack2a8acad8-0ba0-4631-9f6d-f587e7a8558c2024-10-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077042
application number: ANDA077042
ndc (product): 71335-2232
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 TabletPSN2a8acad8-0ba0-4631-9f6d-f587e7a8558c102
309314citalopram 40 MG Oral TabletSCD2a8acad8-0ba0-4631-9f6d-f587e7a8558c102
309314citalopram 40 MG (as citalopram HBr 49.98 MG) Oral TabletSY2a8acad8-0ba0-4631-9f6d-f587e7a8558c102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-2232-17133522320130 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-2232-1) 2023-09-18NoNoCurrent
71335-2232-27133522320240 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-2232-2) 2024-10-04NoNoCurrent
71335-2232-37133522320360 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-2232-3) 2024-10-04NoNoCurrent
71335-2232-47133522320490 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-2232-4) 2023-09-18NoNoCurrent
71335-2232-571335223205100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-2232-5) 2024-10-04NoNoCurrent
71335-2232-671335223206180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-2232-6) 2024-10-04NoNoCurrent