Citalopram

Product NDC
67296-0683
11-digit product format
672960683
Labeler code
67296
Product ID
67296-0683_c20e9153-7427-44bd-9806-bc1a5fd1e439
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Citalopram Hydrobromide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
RedPharm Drug Inc.
Application
ANDA077031
Marketing category
ANDA
Marketing start
2004-10-28
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 productproduct67296-0683IInactivated by FDA2026-08-11
excluded packagepackage67296-068367296-0683-1IInactivated by FDA2026-08-11

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 NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage67296-0683-1d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67296-0683-1f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67296-0683-12ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67296-0683-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage67296-0683-1cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage67296-0683-1cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage67296-0683-1302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage67296-0683-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage67296-0683-10efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage67296-0683-1ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage67296-0683-1367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage67296-0683-1557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage67296-0683-18af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage67296-0683-1834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage67296-0683-11332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage67296-0683-1fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage67296-0683-186f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage67296-0683-1bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage67296-0683-18dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage67296-0683-1e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage67296-0683-19bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage67296-0683-1110d247fa046…a55b01930146…

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
A077031-001CITALOPRAM HYDROBROMIDECITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2004-10-28
A077031-002CITALOPRAM HYDROBROMIDECITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2004-10-28
A077031-003CITALOPRAM HYDROBROMIDECITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2004-10-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A077031-001AB
A077031-002AB
A077031-003AB

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 UTC2026-02A077031-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2004-10-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077031-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2004-10-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077031-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2004-10-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077031-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2004-10-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077031-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2004-10-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077031-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2004-10-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A077031-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2004-10-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077031-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2004-10-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077031-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2004-10-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077031-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2004-10-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077031-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2004-10-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077031-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2004-10-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077031-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2004-10-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077031-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2004-10-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077031-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2004-10-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077031-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2004-10-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077031-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2004-10-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077031-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2004-10-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077031-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2004-10-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077031-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2004-10-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077031-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2004-10-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077031-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2004-10-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077031-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2004-10-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077031-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2004-10-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077031-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2004-10-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077031-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2004-10-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077031-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2004-10-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077031-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2004-10-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A077031-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2004-10-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A077031-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2004-10-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077031-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2004-10-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077031-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2004-10-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077031-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2004-10-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077031-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2004-10-28301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077031-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2004-10-28301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077031-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2004-10-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077031-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2004-10-281e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077031-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2004-10-281e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077031-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2004-10-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077031-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2004-10-288072bd15b7f6…

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 UTC2026-02A077031-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077031-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077031-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077031-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077031-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077031-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077031-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077031-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077031-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077031-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077031-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077031-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077031-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077031-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077031-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077031-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077031-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077031-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077031-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077031-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077031-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077031-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077031-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077031-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077031-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077031-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077031-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077031-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077031-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077031-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077031-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077031-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077031-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077031-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077031-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077031-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077031-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077031-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077031-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077031-001AB18072bd15b7f6…

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
67296-0683-12019-10-29C16284748780-1960f7f55-c4b5-8e05-e053-dbdaa90a074aCitalopram Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-0683-1Citalopram30 in 1 BOTTLETABLET, FILM COATED301

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CITALOPRAM HYDROBROMIDEACTIVE INGREDIENTI1E9D14F36CITALOPRAM (CITALOPRAM HYDROBROMIDE) TABLET, FILM COATED [REDPHARM DRUG INC.]1
CITALOPRAMACTIVE MOIETY0DHU5B8D6VCITALOPRAM (CITALOPRAM HYDROBROMIDE) TABLET, FILM COATED [REDPHARM DRUG INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCITALOPRAM (CITALOPRAM HYDROBROMIDE) TABLET, FILM COATED [REDPHARM DRUG INC.]1
COPOVIDONEINACTIVE INGREDIENTD9C330MD8BCITALOPRAM (CITALOPRAM HYDROBROMIDE) TABLET, FILM COATED [REDPHARM DRUG INC.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CITALOPRAM (CITALOPRAM HYDROBROMIDE) TABLET, FILM COATED [REDPHARM DRUG INC.]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675CITALOPRAM (CITALOPRAM HYDROBROMIDE) TABLET, FILM COATED [REDPHARM DRUG INC.]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTCITALOPRAM (CITALOPRAM HYDROBROMIDE) TABLET, FILM COATED [REDPHARM DRUG INC.]1
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6CITALOPRAM (CITALOPRAM HYDROBROMIDE) TABLET, FILM COATED [REDPHARM DRUG INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCITALOPRAM (CITALOPRAM HYDROBROMIDE) TABLET, FILM COATED [REDPHARM DRUG INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CITALOPRAM (CITALOPRAM HYDROBROMIDE) TABLET, FILM COATED [REDPHARM DRUG INC.]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQCITALOPRAM (CITALOPRAM HYDROBROMIDE) TABLET, FILM COATED [REDPHARM DRUG INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCITALOPRAM (CITALOPRAM HYDROBROMIDE) TABLET, FILM COATED [REDPHARM DRUG INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCITALOPRAM (CITALOPRAM HYDROBROMIDE) TABLET, FILM COATED [REDPHARM DRUG INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-0683CITALOPRAM (CITALOPRAM HYDROBROMIDE) TABLET, FILM COATED [REDPHARM DRUG INC.]1Legacy NDC, 1 package rows20110824_793c9089-8139-4d21-9e8c-64eb0d554063.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 · 19 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CitalopramCITALOPRAM HYDROBROMIDEREMEDYREPACK INC.625a78b2-4751-4ca5-91b6-7c85fd9f8c2e2026-03-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077031
application number: ANDA077031
CitalopramCITALOPRAM HYDROBROMIDENorthwind Health Company, LLCd9cc1649-913d-832d-e053-2995a90a5f9a2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077031
application number: ANDA077031
CitalopramCITALOPRAM HYDROBROMIDENorthwind Health Company, LLCd9ccb3fb-b607-9491-e053-2995a90a39c92026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077031
application number: ANDA077031
CitalopramCITALOPRAM HYDROBROMIDEQPharma, Inc.0a967468-3869-4c8c-849f-9fc3a8dcc4892025-12-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077031
application number: ANDA077031
CitalopramCITALOPRAM HYDROBROMIDEPD-Rx Pharmaceuticals, Inc.31a18cdf-b0aa-18f5-e054-00144ff8d46c2025-10-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077031
application number: ANDA077031
CitalopramCITALOPRAM HYDROBROMIDENuCare Pharmaceuticals,Inc.544ba802-a536-579a-e054-00144ff88e882025-06-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077031
application number: ANDA077031
CitalopramCITALOPRAM HYDROBROMIDEBryant Ranch Prepack0bc0e09e-0f1d-4d52-b8fe-3ef8a2e5ea522025-06-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077031
application number: ANDA077031
CitalopramCITALOPRAM HYDROBROMIDEREMEDYREPACK INC.0109f365-bebd-4810-a56f-4451e10245db2025-04-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077031
application number: ANDA077031
Citalopram HydrobromideCITALOPRAM HYDROBROMIDEAdvanced Rx Pharmacy of Tennessee, LLCf8b06b55-f6a2-2438-e053-6394a90a530a2024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077031
application number: ANDA077031
CitalopramCITALOPRAM HYDROBROMIDEA-S Medication Solutions2500cc9d-a67d-46c5-9a76-99bc63959d672024-10-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077031
application number: ANDA077031
CitalopramCITALOPRAM HYDROBROMIDEA-S Medication Solutionsb244d4eb-8311-4663-8bca-dc08e88e5f5d2024-08-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077031
application number: ANDA077031
CitalopramCITALOPRAM HYDROBROMIDEQUALLENT PHARMACEUTICALS HEALTH LLCe0822069-9672-4d4c-bc1a-8739b0dd045c2024-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077031
application number: ANDA077031
CitalopramCITALOPRAM HYDROBROMIDEAurobindo Pharma Limited2632b547-2e13-447f-ac85-c774e437d6a82024-05-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077031
application number: ANDA077031
CitalopramCITALOPRAM HYDROBROMIDEA-S Medication Solutionsfc766b76-18c1-42cd-b276-f720f5821c112024-04-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077031
application number: ANDA077031
CitalopramCITALOPRAM HYDROBROMIDEA-S Medication Solutionsc6730edc-7226-4521-a04a-1bf296b01b8d2024-02-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077031
application number: ANDA077031
CitalopramCITALOPRAM HYDROBROMIDENCS HealthCare of KY, LLC dba Vangard Labsfd761647-e16b-45b3-a4bc-364de0ed70152023-09-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077031
application number: ANDA077031
CitalopramCITALOPRAM HYDROBROMIDEProficient Rx LPf37cc307-8b7d-4e5c-8beb-cd8779bc86a72022-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077031
application number: ANDA077031
CitalopramCITALOPRAM HYDROBROMIDEAphena Pharma Solutions - Tennessee, LLC31ddd184-7560-473c-b674-5fa3187c55982020-04-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077031
application number: ANDA077031
CitalopramCITALOPRAM HYDROBROMIDEProficient Rx LP289c1d5e-902f-47db-85b8-5e1a55ec86842019-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077031
application number: ANDA077031

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283672citalopram 10 MG Oral TabletPSN793c9089-8139-4d21-9e8c-64eb0d5540631
283672citalopram 10 MG Oral TabletSCD793c9089-8139-4d21-9e8c-64eb0d5540631
283672citalopram 10 MG (as citalopram HBr 12.49 MG) Oral TabletSY793c9089-8139-4d21-9e8c-64eb0d5540631

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
67296-0683-16729606830130 in 1 BOTTLEHistorical