CITALOPRAM HYDROBROMIDE

Product NDC
43353-112
11-digit product format
433530112
Labeler code
43353
Product ID
43353-112_4c38f808-9a23-b5b5-e063-6394a90ae44b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CITALOPRAM
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA077534
Marketing category
ANDA
Marketing start
2012-10-01
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A077534-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2006-10-03caaa826d4ba7…
2026-08-18 06:07:402026-07A077534-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2006-10-03caaa826d4ba7…
2026-08-18 06:07:402026-07A077534-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2006-10-03caaa826d4ba7…
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…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A077534-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077534-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077534-003AB1caaa826d4ba7…
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…

Additional Listing Data#

Finished product
Yes
Brand name base
CITALOPRAM HYDROBROMIDE
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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
200371Internal RxNorm lookup
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
7307df53-d570-4e26-971d-e97522ccce7fAvailable 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
43353-112-15CITALOPRAM HYDROBROMIDE15 in 1 BOTTLETABLET156
43353-112-30CITALOPRAM HYDROBROMIDE30 in 1 BOTTLETABLET306
43353-112-45CITALOPRAM HYDROBROMIDE45 in 1 BOTTLETABLET456
43353-112-53CITALOPRAM HYDROBROMIDE60 in 1 BOTTLETABLET606
43353-112-60CITALOPRAM HYDROBROMIDE90 in 1 BOTTLETABLET906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-112-15EA - Each43353-11215aa6fb7-1003-4f36-914d-be027c6e3a0912016-07-19
43353-112-30EA - Each43353-1121b844d39-85fa-464f-93b1-5e7cb8f391f012026-03-17
43353-112-45EA - Each43353-112ff7bd251-3205-4dd8-9343-67943a7c394212016-07-19
43353-112-53EA - Each43353-112222bb355-6a22-4d0a-bf6b-9b05cdfd7a2f12016-07-19
43353-112-60EA - Each43353-112853e37cf-92b3-430e-a172-f86475783df612016-07-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-112CITALOPRAM HYDROBROMIDE (CITALOPRAM ) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]4Current NDC, Legacy NDC, 5 package rows20171026_7307df53-d570-4e26-971d-e97522ccce7f.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
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
ndc (product): 43353-112
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
200371citalopram 20 MG Oral TabletPSN7307df53-d570-4e26-971d-e97522ccce7f6
309314citalopram 40 MG Oral TabletPSN7307df53-d570-4e26-971d-e97522ccce7f6
200371citalopram 20 MG Oral TabletSCD7307df53-d570-4e26-971d-e97522ccce7f6
309314citalopram 40 MG Oral TabletSCD7307df53-d570-4e26-971d-e97522ccce7f6
200371citalopram 20 MG (as citalopram HBr 24.99 MG) Oral TabletSY7307df53-d570-4e26-971d-e97522ccce7f6
309314citalopram 40 MG (as citalopram HBr 49.98 MG) Oral TabletSY7307df53-d570-4e26-971d-e97522ccce7f6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43353-112-154335301121515 TABLET in 1 BOTTLE (43353-112-15) 15 tablet2015-10-090000-00-00NoNoCurrent
43353-112-304335301123030 TABLET in 1 BOTTLE (43353-112-30) 30 tablet2015-10-09NoNoCurrent
43353-112-454335301124545 TABLET in 1 BOTTLE (43353-112-45) 45 tablet2015-10-090000-00-00NoNoCurrent
43353-112-534335301125360 TABLET in 1 BOTTLE (43353-112-53) 60 tablet2015-10-090000-00-00NoNoCurrent
43353-112-604335301126090 TABLET in 1 BOTTLE (43353-112-60) 90 tablet2015-10-090000-00-00NoNoCurrent