Citalopram Hydrobromide

Product NDC
51655-664
Requested package NDC
51655-664-52
11-digit product format
516550664
Labeler code
51655
Product ID
51655-664_ca3abb22-e8c8-2aaa-e053-2a95a90aa427
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Citalopram Hydrobromide
Dosage form
TABLET
Route
ORAL
Labeler
Northwind Pharmaceuticals, LLC
Application
ANDA078216
Marketing category
ANDA
Marketing start
2015-02-16
Marketing end
0000-00-00
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
2022-12-31
Current FDA listing
Historical FDA.report record

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage51655-66451655-664-52IInactivated by FDAexcluded / ndc_excluded.zipe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage51655-66451655-664-52IInactivated by FDAexcluded / ndc_excluded.zip9bebd1f3094a…5416666fcb17…

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
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 · 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 UTC2026-02A078216-001CITALOPRAM 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…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078216-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2007-03-271e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078216-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2007-03-271e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078216-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2007-03-278072bd15b7f6…

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 UTC2026-02A078216-001AB1011fe1cb6892…
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…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078216-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078216-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078216-001AB18072bd15b7f6…

Additional Listing Data#

Finished product
Yes
Brand name base
Citalopram
Listing expiration
2027-12-31

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 · 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
a7ef6ad2-5f22-4ac7-b57a-f498bcb53be1Available 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
51655-664-252026-01-29These 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
51655-664-252026-01-29These 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
51655-664-262026-01-29These 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
51655-664-262026-01-29These 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
51655-664-522026-01-29These 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
51655-664-522026-01-29These 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
51655-664-252023-04-18These 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
51655-664-252023-04-18These 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
51655-664-522023-04-18These 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
51655-664-522023-04-18These 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
51655-664-252023-01-30These 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
51655-664-252023-01-30These 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
51655-664-522023-01-30These 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
51655-664-522023-01-30These 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
51655-664-522021-08-23These 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
51655-664-522021-08-23These 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
51655-664-522020-01-31These 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
51655-664-522020-01-31These 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51655-664-25Citalopram Hydrobromide60 in 1 BOTTLE, DISPENSINGTABLET605
51655-664-26Citalopram Hydrobromide90 in 1 BOTTLE, PLASTICTABLET905
51655-664-52Citalopram Hydrobromide30 in 1 BOTTLE, DISPENSINGTABLET305

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CITALOPRAM HYDROBROMIDEACTIVE INGREDIENTI1E9D14F36CITALOPRAM HYDROBROMIDE TABLET [NORTHWIND PHARMACEUTICALS, LLC]1
CITALOPRAMACTIVE MOIETY0DHU5B8D6VCITALOPRAM HYDROBROMIDE TABLET [NORTHWIND PHARMACEUTICALS, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-664CITALOPRAM HYDROBROMIDE TABLET [NORTHWIND PHARMACEUTICALS, LLC]5Legacy NDC, 3 package rows20240727_a7ef6ad2-5f22-4ac7-b57a-f498bcb53be1.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
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
ndc (package): 51655-664-52
ndc (product): 51655-664
ndc11 (package): 51655066452

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200371citalopram 20 MG Oral TabletPSNa7ef6ad2-5f22-4ac7-b57a-f498bcb53be15
309314citalopram 40 MG Oral TabletPSNa7ef6ad2-5f22-4ac7-b57a-f498bcb53be15
200371citalopram 20 MG Oral TabletSCDa7ef6ad2-5f22-4ac7-b57a-f498bcb53be15
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51655-664-525165506645230 TABLET in 1 BOTTLE, DISPENSING (51655-664-52) 30 tablet2015-02-160000-00-00NoNoCurrent