Citalopram

Product NDC
13668-011
11-digit product format
136680011
Labeler code
13668
Product ID
13668-011_48423caf-4df2-4653-a8ed-b28462757ed3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Citalopram
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Torrent Pharmaceuticals Limited
Application
ANDA078216
Marketing category
ANDA
Marketing start
2007-10-18
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
A078216-001CITALOPRAM HYDROBROMIDECITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2007-03-27
A078216-002CITALOPRAM HYDROBROMIDECITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2007-03-27
A078216-003CITALOPRAM HYDROBROMIDECITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2007-03-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A078216-001AB
A078216-002AB
A078216-003AB

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 06:07:402026-07A078216-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2007-03-27caaa826d4ba7…
2026-08-18 06:07:402026-07A078216-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2007-03-27caaa826d4ba7…
2026-08-18 06:07:402026-07A078216-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2007-03-27caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078216-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2007-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078216-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2007-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078216-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2007-03-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078216-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2007-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078216-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2007-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078216-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2007-03-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A078216-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2007-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078216-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2007-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078216-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2007-03-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078216-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2007-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078216-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2007-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078216-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2007-03-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078216-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2007-03-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078216-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2007-03-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078216-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2007-03-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078216-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2007-03-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078216-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2007-03-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078216-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2007-03-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078216-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2007-03-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078216-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2007-03-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078216-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2007-03-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078216-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2007-03-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078216-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2007-03-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078216-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2007-03-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078216-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2007-03-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078216-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2007-03-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078216-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2007-03-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078216-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2007-03-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A078216-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2007-03-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A078216-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2007-03-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078216-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2007-03-2779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078216-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2007-03-2779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078216-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2007-03-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078216-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2007-03-27301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078216-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2007-03-27301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078216-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2007-03-27301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078216-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2007-03-271e350fbaab3a…

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 06:07:402026-07A078216-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078216-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078216-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078216-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078216-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078216-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078216-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078216-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078216-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078216-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078216-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078216-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078216-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078216-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078216-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078216-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078216-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078216-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078216-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078216-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078216-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078216-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078216-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078216-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078216-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078216-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078216-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078216-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078216-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078216-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078216-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078216-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078216-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078216-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078216-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078216-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078216-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078216-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078216-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078216-001AB11e350fbaab3a…

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 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
200371Internal RxNorm lookup
283672Internal 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
04766f1d-7a69-49ed-8fd3-1a6305505d47Available 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
13668-011-01Citalopram100 in 1 BOTTLETABLET, FILM COATED10023
13668-011-05Citalopram500 in 1 BOTTLETABLET, FILM COATED50023
13668-011-08Citalopram2800 in 1 BOTTLETABLET, FILM COATED280023
13668-011-30Citalopram30 in 1 BOTTLETABLET, FILM COATED3023

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13668-011-01EA - Each13668-0112e53bb75-95af-469e-bb0b-8140370f2fc012012-07-24
13668-011-05EA - Each13668-0113a1f9923-75b9-48f1-bf91-b6d2771c695812012-07-24
13668-011-08EA - Each13668-0110d73bc23-b13b-4b84-949c-f2b56ac5b21c12012-07-24
13668-011-30EA - Each13668-011cd545c7a-806a-4ee2-8082-3432c67f6c3012012-07-24
13668-011-74EA - Each13668-01183dc3960-b389-4afb-bbdd-8f329f82136312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CITALOPRAM HYDROBROMIDEACTIVE INGREDIENTI1E9D14F36CITALOPRAM HYDROBROMIDE TABLET [TORRENT PHARMACEUTICALS LIMITED]8
CITALOPRAMACTIVE MOIETY0DHU5B8D6VCITALOPRAM HYDROBROMIDE TABLET [TORRENT PHARMACEUTICALS LIMITED]8
CITALOPRAM HYDROBROMIDEACTIVE INGREDIENTI1E9D14F36CITALOPRAM HYDROBROMIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]4
CITALOPRAMACTIVE MOIETY0DHU5B8D6VCITALOPRAM HYDROBROMIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCITALOPRAM HYDROBROMIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]4
COPOVIDONE K25-31INACTIVE INGREDIENTD9C330MD8BCITALOPRAM HYDROBROMIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]4
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CITALOPRAM HYDROBROMIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]4
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675CITALOPRAM HYDROBROMIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]4
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTCITALOPRAM HYDROBROMIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]4
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCITALOPRAM HYDROBROMIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCITALOPRAM HYDROBROMIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCITALOPRAM HYDROBROMIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CITALOPRAM HYDROBROMIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]4
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACITALOPRAM HYDROBROMIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCITALOPRAM HYDROBROMIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCITALOPRAM HYDROBROMIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]4
CITALOPRAM HYDROBROMIDEACTIVE INGREDIENTI1E9D14F36CITALOPRAM HYDROBROMIDE TABLET [STAT RX USA]2
CITALOPRAMACTIVE MOIETY0DHU5B8D6VCITALOPRAM HYDROBROMIDE TABLET [STAT RX USA]2
CITALOPRAM HYDROBROMIDEACTIVE INGREDIENTI1E9D14F36CITALOPRAM HYDROBROMIDE TABLET [NORTHWIND PHARMACEUTICALS, LLC]1
CITALOPRAM HYDROBROMIDEACTIVE INGREDIENTI1E9D14F36CITALOPRAM HYDROBROMIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
CITALOPRAM HYDROBROMIDEACTIVE INGREDIENTI1E9D14F36CITALOPRAM HYDROBROMIDE TABLET [MEDVANTX, INC.]1
CITALOPRAM HYDROBROMIDEACTIVE INGREDIENTI1E9D14F36DIRECT RX (CITALOPRAM) TABLET [DIRECT RX]1
CITALOPRAM HYDROBROMIDEACTIVE INGREDIENTI1E9D14F36CITALOPRAM HYDROBROMIDE TABLET [CONTRACT PHARMACY SERVICES-PA]1
CITALOPRAM HYDROBROMIDEACTIVE INGREDIENTI1E9D14F36CITALOPRAM HYDROBROMIDE TABLET [REBEL DISTRIBUTORS CORP]1
CITALOPRAMACTIVE MOIETY0DHU5B8D6VDIRECT RX (CITALOPRAM) TABLET [DIRECT RX]1
CITALOPRAMACTIVE MOIETY0DHU5B8D6VCITALOPRAM HYDROBROMIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
CITALOPRAMACTIVE MOIETY0DHU5B8D6VCITALOPRAM HYDROBROMIDE TABLET [REBEL DISTRIBUTORS CORP]1
CITALOPRAMACTIVE MOIETY0DHU5B8D6VCITALOPRAM HYDROBROMIDE TABLET [MEDVANTX, INC.]1
CITALOPRAMACTIVE MOIETY0DHU5B8D6VCITALOPRAM HYDROBROMIDE TABLET [NORTHWIND PHARMACEUTICALS, LLC]1
CITALOPRAMACTIVE MOIETY0DHU5B8D6VCITALOPRAM HYDROBROMIDE TABLET [CONTRACT PHARMACY SERVICES-PA]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCITALOPRAM HYDROBROMIDE TABLET [REBEL DISTRIBUTORS CORP]1
COPOVIDONE K25-31INACTIVE INGREDIENTD9C330MD8BCITALOPRAM HYDROBROMIDE TABLET [REBEL DISTRIBUTORS CORP]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CITALOPRAM HYDROBROMIDE TABLET [REBEL DISTRIBUTORS CORP]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675CITALOPRAM HYDROBROMIDE TABLET [REBEL DISTRIBUTORS CORP]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTCITALOPRAM HYDROBROMIDE TABLET [REBEL DISTRIBUTORS CORP]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCITALOPRAM HYDROBROMIDE TABLET [REBEL DISTRIBUTORS CORP]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCITALOPRAM HYDROBROMIDE TABLET [REBEL DISTRIBUTORS CORP]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCITALOPRAM HYDROBROMIDE TABLET [REBEL DISTRIBUTORS CORP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CITALOPRAM HYDROBROMIDE TABLET [REBEL DISTRIBUTORS CORP]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACITALOPRAM HYDROBROMIDE TABLET [REBEL DISTRIBUTORS CORP]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCITALOPRAM HYDROBROMIDE TABLET [REBEL DISTRIBUTORS CORP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCITALOPRAM HYDROBROMIDE TABLET [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13668-011CITALOPRAM TABLET, FILM COATED [TORRENT PHARMACEUTICALS LIMITED]22Current NDC, Legacy NDC, 4 package rows20250125_04766f1d-7a69-49ed-8fd3-1a6305505d47.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 2 · 39 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CitalopramCITALOPRAMPD-Rx Pharmaceuticals, Inc.9fe40d83-8945-4577-add5-28d52410154e2026-07-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078216
application number: ANDA078216
CitalopramCITALOPRAMSt. Mary's Medical Park Pharmacydb900453-4777-4142-a236-5d3a6152d0a52026-06-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078216
application number: ANDA078216
CitalopramCITALOPRAMCoupler LLC53e5d66f-7902-76ac-e063-6294a90aa5262026-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078216
application number: ANDA078216
CitalopramCITALOPRAMCoupler LLC53e6d0a4-95d9-9c1a-e063-6294a90a9d182026-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078216
application number: ANDA078216
CitalopramCITALOPRAMBryant Ranch Prepack9b53c14c-224c-49ed-8a00-96f871593ab02026-06-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078216
application number: ANDA078216
CitalopramCITALOPRAMASCLEMED USA INC.df8db06a-ced7-4dd6-83bd-c61d2f68f1b12026-05-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078216
application number: ANDA078216
CitalopramCITALOPRAMSt. Mary's Medical Park Pharmacy351ca54b-0eb6-4e93-8ab4-82fb18dcc9e12026-05-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078216
application number: ANDA078216
CitalopramCITALOPRAMQPharma, Inc.f35bfd9e-afb6-409d-a804-6073d812609d2026-05-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078216
application number: ANDA078216
CitalopramCITALOPRAMPD-Rx Pharmaceuticals, Inc.43785b49-5d1e-4ae9-b2ff-26be910bde7f2026-05-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078216
application number: ANDA078216
CitalopramCITALOPRAMREMEDYREPACK INC.a26772e7-6e4d-489b-bb5e-5bc322ef6dfe2026-05-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078216
application number: ANDA078216
CitalopramCITALOPRAMPD-Rx Pharmaceuticals, Inc.df929b3f-0cda-4a75-96d3-22e6b0edbbc92026-04-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078216
application number: ANDA078216
CitalopramCITALOPRAMREMEDYREPACK INC.bdc0c228-797a-42dd-8114-aa68c1eb33002026-04-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078216
application number: ANDA078216
CitalopramCITALOPRAMCoupler LLC50380ce5-c77f-3ee3-e063-6394a90a17ae2026-04-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078216
application number: ANDA078216
CitalopramCITALOPRAMCardinal Health 107, LLC6c8942f8-963a-4007-a147-b77ac629e4d42026-04-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078216
application number: ANDA078216
Citalopram HydrobromideCITALOPRAM HYDROBROMIDEPreferred Pharmaceuticals Inc.27ddea53-f03d-4760-99bb-ec8efa44ff622026-03-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078216
application number: ANDA078216
CitalopramCITALOPRAMBryant Ranch Prepackbef27fa1-7876-4ce3-834c-a4855aec66c92026-03-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078216
application number: ANDA078216
CitalopramCITALOPRAMMajor Pharmaceuticalsa6949652-b15b-435b-9097-2219f398ac052026-02-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078216
application number: ANDA078216
CitalopramCITALOPRAMTorrent Pharmaceuticals Limited04766f1d-7a69-49ed-8fd3-1a6305505d472026-02-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078216
application number: ANDA078216
ndc (product): 13668-011
Citalopram HydrobromideCITALOPRAM HYDROBROMIDEPreferred Pharmaceuticals, Inc.b52acd68-fed1-4680-9eaf-b72e7dcba6fb2026-01-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078216
application number: ANDA078216
CitalopramCITALOPRAMNorthwind Health Company, LLCa7ef6ad2-5f22-4ac7-b57a-f498bcb53be12026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078216
application number: ANDA078216

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309314citalopram 40 MG Oral TabletPSN15cb00da-4435-4930-90d0-faadf2739a5c108
309314citalopram 40 MG Oral TabletSCD15cb00da-4435-4930-90d0-faadf2739a5c108
309314citalopram 40 MG (as citalopram HBr 49.98 MG) Oral TabletSY15cb00da-4435-4930-90d0-faadf2739a5c108
283672citalopram 10 MG Oral TabletPSN05421bee-f746-418e-bb9c-ab44a89b567d32
200371citalopram 20 MG Oral TabletPSN05421bee-f746-418e-bb9c-ab44a89b567d32
309314citalopram 40 MG Oral TabletPSN05421bee-f746-418e-bb9c-ab44a89b567d32
283672citalopram 10 MG Oral TabletSCD05421bee-f746-418e-bb9c-ab44a89b567d32
200371citalopram 20 MG Oral TabletSCD05421bee-f746-418e-bb9c-ab44a89b567d32
309314citalopram 40 MG Oral TabletSCD05421bee-f746-418e-bb9c-ab44a89b567d32
283672citalopram 10 MG (as citalopram HBr 12.49 MG) Oral TabletSY05421bee-f746-418e-bb9c-ab44a89b567d32
200371citalopram 20 MG (as citalopram HBr 24.99 MG) Oral TabletSY05421bee-f746-418e-bb9c-ab44a89b567d32
309314citalopram 40 MG (as citalopram HBr 49.98 MG) Oral TabletSY05421bee-f746-418e-bb9c-ab44a89b567d32
309314citalopram 40 MG Oral TabletPSN9fe40d83-8945-4577-add5-28d52410154e25
309314citalopram 40 MG Oral TabletSCD9fe40d83-8945-4577-add5-28d52410154e25
309314citalopram 40 MG (as citalopram HBr 49.98 MG) Oral TabletSY9fe40d83-8945-4577-add5-28d52410154e25
283672citalopram 10 MG Oral TabletPSN04766f1d-7a69-49ed-8fd3-1a6305505d4723
200371citalopram 20 MG Oral TabletPSN04766f1d-7a69-49ed-8fd3-1a6305505d4723
309314citalopram 40 MG Oral TabletPSN04766f1d-7a69-49ed-8fd3-1a6305505d4723
283672citalopram 10 MG Oral TabletSCD04766f1d-7a69-49ed-8fd3-1a6305505d4723
200371citalopram 20 MG Oral TabletSCD04766f1d-7a69-49ed-8fd3-1a6305505d4723
309314citalopram 40 MG Oral TabletSCD04766f1d-7a69-49ed-8fd3-1a6305505d4723
283672citalopram 10 MG (as citalopram HBr 12.49 MG) Oral TabletSY04766f1d-7a69-49ed-8fd3-1a6305505d4723
200371citalopram 20 MG (as citalopram HBr 24.99 MG) Oral TabletSY04766f1d-7a69-49ed-8fd3-1a6305505d4723
309314citalopram 40 MG (as citalopram HBr 49.98 MG) Oral TabletSY04766f1d-7a69-49ed-8fd3-1a6305505d4723
309314citalopram 40 MG Oral TabletPSN27ddea53-f03d-4760-99bb-ec8efa44ff6211
309314citalopram 40 MG Oral TabletSCD27ddea53-f03d-4760-99bb-ec8efa44ff6211
309314citalopram 40 MG (as citalopram HBr 49.98 MG) Oral TabletSY27ddea53-f03d-4760-99bb-ec8efa44ff6211
309314citalopram 40 MG Oral TabletPSN35b05031-3319-4806-92af-72fbe2ec04ac8
309314citalopram 40 MG Oral TabletSCD35b05031-3319-4806-92af-72fbe2ec04ac8
309314citalopram 40 MG (as citalopram HBr 49.98 MG) Oral TabletSY35b05031-3319-4806-92af-72fbe2ec04ac8
200371citalopram 20 MG Oral TabletPSNa7ef6ad2-5f22-4ac7-b57a-f498bcb53be15
309314citalopram 40 MG Oral TabletPSNa7ef6ad2-5f22-4ac7-b57a-f498bcb53be15
309314citalopram 40 MG Oral TabletPSN83e7ab2a-cf40-490b-aa7e-2ace88a7445d5
200371citalopram 20 MG Oral TabletSCDa7ef6ad2-5f22-4ac7-b57a-f498bcb53be15
309314citalopram 40 MG Oral TabletSCD83e7ab2a-cf40-490b-aa7e-2ace88a7445d5
309314citalopram 40 MG Oral TabletSCDa7ef6ad2-5f22-4ac7-b57a-f498bcb53be15
200371citalopram 20 MG (as citalopram HBr 24.99 MG) Oral TabletSYa7ef6ad2-5f22-4ac7-b57a-f498bcb53be15
309314citalopram 40 MG (as citalopram HBr 49.98 MG) Oral TabletSYa7ef6ad2-5f22-4ac7-b57a-f498bcb53be15
309314citalopram 40 MG (as citalopram HBr 49.98 MG) Oral TabletSY83e7ab2a-cf40-490b-aa7e-2ace88a7445d5
309314citalopram 40 MG Oral TabletPSN356f48c3-3b0e-65b5-e054-00144ff8d46c4
309314citalopram 40 MG Oral TabletSCD356f48c3-3b0e-65b5-e054-00144ff8d46c4
309314citalopram 40 MG (as citalopram HBr 49.98 MG) Oral TabletSY356f48c3-3b0e-65b5-e054-00144ff8d46c4
309314citalopram 40 MG Oral TabletPSN549a5b3f-4928-1ae5-e054-00144ff8d46c3
309314citalopram 40 MG Oral TabletSCD549a5b3f-4928-1ae5-e054-00144ff8d46c3
309314citalopram 40 MG (as citalopram HBr 49.98 MG) Oral TabletSY549a5b3f-4928-1ae5-e054-00144ff8d46c3
283672citalopram 10 MG Oral TabletPSN26683db8-b319-4d67-8cd8-3c9803daa6282
200371citalopram 20 MG Oral TabletPSN26683db8-b319-4d67-8cd8-3c9803daa6282
309314citalopram 40 MG Oral TabletPSN00a3e8f8-530b-4355-b959-3eaa2542eed32
309314citalopram 40 MG Oral TabletPSN26683db8-b319-4d67-8cd8-3c9803daa6282
283672citalopram 10 MG Oral TabletSCD26683db8-b319-4d67-8cd8-3c9803daa6282
200371citalopram 20 MG Oral TabletSCD26683db8-b319-4d67-8cd8-3c9803daa6282
309314citalopram 40 MG Oral TabletSCD26683db8-b319-4d67-8cd8-3c9803daa6282
309314citalopram 40 MG Oral TabletSCD00a3e8f8-530b-4355-b959-3eaa2542eed32
283672citalopram 10 MG (as citalopram HBr 12.49 MG) Oral TabletSY26683db8-b319-4d67-8cd8-3c9803daa6282
200371citalopram 20 MG (as citalopram HBr 24.99 MG) Oral TabletSY26683db8-b319-4d67-8cd8-3c9803daa6282
309314citalopram 40 MG (as citalopram HBr 49.98 MG) Oral TabletSY00a3e8f8-530b-4355-b959-3eaa2542eed32
309314citalopram 40 MG (as citalopram HBr 49.98 MG) Oral TabletSY26683db8-b319-4d67-8cd8-3c9803daa6282
283672citalopram 10 MG Oral TabletPSN34d1685a-8e6a-46bc-8977-550979bf4ddd1
283672citalopram 10 MG Oral TabletPSN3993eb55-f0e8-496c-a496-19dc509699e81
283672citalopram 10 MG Oral TabletPSN16715e29-86e8-48b3-8c12-da70e58939011
200371citalopram 20 MG Oral TabletPSN3993eb55-f0e8-496c-a496-19dc509699e81
200371citalopram 20 MG Oral TabletPSN16715e29-86e8-48b3-8c12-da70e58939011
200371citalopram 20 MG Oral TabletPSN34d1685a-8e6a-46bc-8977-550979bf4ddd1
309314citalopram 40 MG Oral TabletPSNe844a4cf-bbab-21a0-e053-2995a90a1f6c1
309314citalopram 40 MG Oral TabletPSNb6052b11-a7c1-4f55-8ef5-239541c466ff1
309314citalopram 40 MG Oral TabletPSN16715e29-86e8-48b3-8c12-da70e58939011
309314citalopram 40 MG Oral TabletPSN9059c8f1-8755-492d-aba2-5f5088ce69d31
309314citalopram 40 MG Oral TabletPSN34d1685a-8e6a-46bc-8977-550979bf4ddd1
309314citalopram 40 MG Oral TabletPSN4eb71151-241a-476e-a495-4a021bc55bda1
309314citalopram 40 MG Oral TabletPSN3993eb55-f0e8-496c-a496-19dc509699e81
283672citalopram 10 MG Oral TabletSCD16715e29-86e8-48b3-8c12-da70e58939011
283672citalopram 10 MG Oral TabletSCD3993eb55-f0e8-496c-a496-19dc509699e81
283672citalopram 10 MG Oral TabletSCD34d1685a-8e6a-46bc-8977-550979bf4ddd1
200371citalopram 20 MG Oral TabletSCD3993eb55-f0e8-496c-a496-19dc509699e81
200371citalopram 20 MG Oral TabletSCD34d1685a-8e6a-46bc-8977-550979bf4ddd1
200371citalopram 20 MG Oral TabletSCD16715e29-86e8-48b3-8c12-da70e58939011
309314citalopram 40 MG Oral TabletSCD34d1685a-8e6a-46bc-8977-550979bf4ddd1
309314citalopram 40 MG Oral TabletSCDe844a4cf-bbab-21a0-e053-2995a90a1f6c1
309314citalopram 40 MG Oral TabletSCD9059c8f1-8755-492d-aba2-5f5088ce69d31
309314citalopram 40 MG Oral TabletSCDb6052b11-a7c1-4f55-8ef5-239541c466ff1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
13668-011-0113668001101100 TABLET, FILM COATED in 1 BOTTLE (13668-011-01) 2007-10-180000-00-00NoNoCurrent
13668-011-0513668001105500 TABLET, FILM COATED in 1 BOTTLE (13668-011-05) 2007-10-180000-00-00NoNoCurrent
13668-011-08136680011082800 TABLET, FILM COATED in 1 BOTTLE (13668-011-08) 2007-10-180000-00-00NoNoCurrent
13668-011-301366800113030 TABLET, FILM COATED in 1 BOTTLE (13668-011-30) 2007-10-180000-00-00NoNoCurrent
13668-011-7413668001174100 TABLET in 1 CARTON (13668-011-74) 100 tablet2007-10-180000-00-00NoNoCurrent