citalopram hydrobromide

Product NDC
64725-0507
11-digit product format
647250507
Labeler code
64725
Product ID
64725-0507_3dabf6fb-1c36-4841-b8af-61a0690c7f90
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
citalopram hydrobromide
Dosage form
TABLET
Route
ORAL
Labeler
TYA Pharmaceuticals
Application
ANDA077032
Marketing category
ANDA
Marketing start
2004-11-12
Marketing end
0000-00-00
Substance
CITALOPRAM HYDROBROMIDE
Active strength
10 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct64725-0507IInactivated by FDA2026-10-05
excluded packagepackage64725-050764725-0507-1IInactivated by FDA2026-10-05

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 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage64725-0507-1IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage64725-0507-1IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage64725-0507-1IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage64725-0507-1IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage64725-0507-1IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage64725-0507-1IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage64725-0507-1IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage64725-0507-1IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage64725-0507-1IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage64725-0507-1IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage64725-0507-1IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage64725-0507-1IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage64725-0507-1IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage64725-0507-1IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage64725-0507-1IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage64725-0507-1IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage64725-0507-1IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage64725-0507-1IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage64725-0507-1IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage64725-0507-1IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage64725-0507-1IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage64725-0507-1EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A077032-001CITALOPRAM HYDROBROMIDECITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORAL2004-11-12
A077032-002CITALOPRAM HYDROBROMIDECITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORAL2004-11-12
A077032-003CITALOPRAM HYDROBROMIDECITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORAL2004-11-12

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 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A077032-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORAL2004-11-1284e616aacf4f…
2026-09-14 22:38:342026-08A077032-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORAL2004-11-1284e616aacf4f…
2026-09-14 22:38:342026-08A077032-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORAL2004-11-1284e616aacf4f…
2026-08-18 06:07:402026-07A077032-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORAL2004-11-12caaa826d4ba7…
2026-08-18 06:07:402026-07A077032-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORAL2004-11-12caaa826d4ba7…
2026-08-18 06:07:402026-07A077032-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORAL2004-11-12caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077032-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORAL2004-11-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077032-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORAL2004-11-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077032-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORAL2004-11-12011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077032-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORAL2004-11-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077032-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORAL2004-11-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077032-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORAL2004-11-1231067a03dcf5…
2025-08-23 18:47 UTC2025-08A077032-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORAL2004-11-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077032-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORAL2004-11-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077032-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORAL2004-11-126a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077032-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORAL2004-11-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077032-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORAL2004-11-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077032-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORAL2004-11-12fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077032-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORAL2004-11-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077032-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORAL2004-11-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077032-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORAL2004-11-12b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077032-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORAL2004-11-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077032-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORAL2004-11-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077032-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORAL2004-11-1203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077032-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORAL2004-11-122680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077032-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORAL2004-11-122680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077032-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORAL2004-11-122680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077032-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORAL2004-11-125bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077032-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORAL2004-11-125bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077032-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORAL2004-11-125bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077032-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORAL2004-11-12d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077032-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORAL2004-11-12d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077032-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORAL2004-11-12d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077032-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORAL2004-11-12d06236e962d9…
2024-10-29 15:01 UTC2024-10A077032-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORAL2004-11-12d06236e962d9…
2024-10-29 15:01 UTC2024-10A077032-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORAL2004-11-12d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077032-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORAL2004-11-1279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077032-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORAL2004-11-1279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077032-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORAL2004-11-1279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077032-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORAL2004-11-12301d65b070ca…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-09-15 20:21 UTC2019-09A077032-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A077032-002AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A077032-003AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A077032-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A077032-002AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A077032-003AB1ea99ee380514…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64725-0507-12020-01-31C16284748780-19d75b9d0-e93b-f424-e053-dadaa90a57ce7d8c8762-e491-4798-8866-0db6425308e8

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64725-0507-1citalopram hydrobromide100 in 1 BOTTLETABLET1002

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CITALOPRAM HYDROBROMIDEACTIVE INGREDIENTI1E9D14F36CITALOPRAM HYDROBROMIDE TABLET [TYA PHARMACEUTICALS]2
CITALOPRAMACTIVE MOIETY0DHU5B8D6VCITALOPRAM HYDROBROMIDE TABLET [TYA PHARMACEUTICALS]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCITALOPRAM HYDROBROMIDE TABLET [TYA PHARMACEUTICALS]2
COPOVIDONE K25-31INACTIVE INGREDIENTD9C330MD8BCITALOPRAM HYDROBROMIDE TABLET [TYA PHARMACEUTICALS]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CITALOPRAM HYDROBROMIDE TABLET [TYA PHARMACEUTICALS]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675CITALOPRAM HYDROBROMIDE TABLET [TYA PHARMACEUTICALS]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTCITALOPRAM HYDROBROMIDE TABLET [TYA PHARMACEUTICALS]2
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6CITALOPRAM HYDROBROMIDE TABLET [TYA PHARMACEUTICALS]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCITALOPRAM HYDROBROMIDE TABLET [TYA PHARMACEUTICALS]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CITALOPRAM HYDROBROMIDE TABLET [TYA PHARMACEUTICALS]2
POLYETHYLENE GLYCOL 4000INACTIVE INGREDIENT4R4HFI6D95CITALOPRAM HYDROBROMIDE TABLET [TYA PHARMACEUTICALS]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CITALOPRAM HYDROBROMIDE TABLET [TYA PHARMACEUTICALS]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCITALOPRAM HYDROBROMIDE TABLET [TYA PHARMACEUTICALS]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCITALOPRAM HYDROBROMIDE TABLET [TYA PHARMACEUTICALS]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64725-0507CITALOPRAM HYDROBROMIDE TABLET [TYA PHARMACEUTICALS]2Legacy NDC, 1 package rows20141031_7d8c8762-e491-4798-8866-0db6425308e8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283672citalopram 10 MG Oral TabletPSN7d8c8762-e491-4798-8866-0db6425308e82
283672citalopram 10 MG Oral TabletSCD7d8c8762-e491-4798-8866-0db6425308e82
283672citalopram 10 MG (as citalopram HBr 12.49 MG) Oral TabletSY7d8c8762-e491-4798-8866-0db6425308e82

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
64725-0507-164725050701100 in 1 BOTTLEHistorical