CITALOPRAM HYDROBROMIDE

Product NDC
76282-206
11-digit product format
762820206
Labeler code
76282
Product ID
76282-206_11799cc5-454b-4581-ab28-34854f0deb40
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CITALOPRAM
Dosage form
TABLET
Route
ORAL
Labeler
Exelan Pharmaceuticals Inc.
Application
ANDA077534
Marketing category
ANDA
Marketing start
2012-10-01
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
No
Listing certified through
2023-12-31
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 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct76282-206DDiscontinued by firm2026-08-11
excluded packagepackage76282-20676282-206-05DDiscontinued by firm2026-08-11
excluded packagepackage76282-20676282-206-10DDiscontinued by firm2026-08-11
excluded packagepackage76282-20676282-206-30DDiscontinued by firm2026-08-11
excluded packagepackage76282-20676282-206-90DDiscontinued by firm2026-08-11

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 · 60 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 packagepackage76282-206-05d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage76282-206-90d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage76282-206-10d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage76282-206-30d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage76282-206-05f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage76282-206-90f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage76282-206-10f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage76282-206-30f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage76282-206-052ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage76282-206-902ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage76282-206-102ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage76282-206-302ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage76282-206-05a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage76282-206-90a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage76282-206-10a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage76282-206-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage76282-206-05cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage76282-206-90cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage76282-206-10cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage76282-206-30cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage76282-206-05cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage76282-206-90cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage76282-206-10cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage76282-206-30cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage76282-206-05302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage76282-206-90302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage76282-206-10302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage76282-206-30302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage76282-206-05ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage76282-206-90ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage76282-206-10ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage76282-206-30ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage76282-206-050efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage76282-206-900efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage76282-206-100efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage76282-206-300efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage76282-206-05ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage76282-206-90ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage76282-206-10ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage76282-206-30ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage76282-206-05367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage76282-206-90367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage76282-206-10367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage76282-206-30367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage76282-206-05557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage76282-206-90557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage76282-206-10557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage76282-206-30557ba5c1ecfa…9c80585c8c6e…

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
A077534-001CITALOPRAM HYDROBROMIDECITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2006-10-03
A077534-002CITALOPRAM HYDROBROMIDECITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2006-10-03
A077534-003CITALOPRAM HYDROBROMIDECITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2006-10-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A077534-001AB
A077534-002AB
A077534-003AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 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 UTC2026-02A077534-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2006-10-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077534-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2006-10-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077534-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2006-10-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077534-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2006-10-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077534-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2006-10-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077534-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2006-10-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08A077534-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2006-10-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077534-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2006-10-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077534-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2006-10-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077534-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2006-10-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077534-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2006-10-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077534-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2006-10-03fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077534-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2006-10-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077534-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2006-10-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077534-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2006-10-03b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077534-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2006-10-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077534-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2006-10-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077534-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2006-10-0303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077534-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2006-10-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077534-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2006-10-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077534-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2006-10-032680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077534-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2006-10-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077534-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2006-10-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077534-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2006-10-035bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077534-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2006-10-03d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077534-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2006-10-03d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077534-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2006-10-03d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077534-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2006-10-03d06236e962d9…
2024-10-29 15:01 UTC2024-10A077534-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2006-10-03d06236e962d9…
2024-10-29 15:01 UTC2024-10A077534-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2006-10-03d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077534-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2006-10-0379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077534-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2006-10-0379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077534-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2006-10-0379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077534-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2006-10-03301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077534-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2006-10-03301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077534-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2006-10-03301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077534-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2006-10-031e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077534-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2006-10-031e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077534-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2006-10-031e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077534-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2006-10-038072bd15b7f6…

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 UTC2026-02A077534-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077534-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077534-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077534-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077534-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077534-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077534-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077534-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077534-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077534-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077534-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077534-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077534-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077534-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077534-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077534-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077534-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077534-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077534-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077534-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077534-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077534-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077534-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077534-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077534-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077534-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077534-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077534-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077534-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077534-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077534-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077534-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077534-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077534-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077534-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077534-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077534-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077534-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077534-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077534-001AB18072bd15b7f6…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76282-206-01EA - Each76282-2064dd754cd-e019-4448-9edf-9fbd35fbc04212013-02-13
76282-206-05EA - Each76282-20601f73ae6-96d4-449d-bd21-fdd4337a126d12013-02-13
76282-206-10EA - Each76282-20699df3585-5f4e-40e7-a4c6-ff8a9ccac74712013-02-13
76282-206-90EA - Each76282-20689d25f2f-1335-4ae6-87a4-ad4e22d722af12017-09-11

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 13 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CitalopramCITALOPRAMREMEDYREPACK INC.c9809dfe-939e-4f9d-b6dd-f9808fd9f2b12026-07-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077534
application number: ANDA077534
CitalopramCITALOPRAMREMEDYREPACK INC.25b0d184-2a4c-42b0-9a57-7a00fa3e0cd72026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077534
application number: ANDA077534
CITALOPRAM HYDROBROMIDECITALOPRAMAphena Pharma Solutions - Tennessee, LLC7307df53-d570-4e26-971d-e97522ccce7f2026-03-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077534
application number: ANDA077534
CitalopramCITALOPRAMNorthwind Health Company, LLCf2b42bdc-47e0-19c5-e053-2a95a90a18282026-01-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077534
application number: ANDA077534
CitalopramCITALOPRAMNorthwind Health Company, LLCf2b54f10-221f-5eed-e053-2995a90ab47f2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077534
application number: ANDA077534
CitalopramCITALOPRAMNorthwind Health Company, LLCf77ef23b-3015-d074-e053-6394a90a11e12026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077534
application number: ANDA077534
CitalopramCITALOPRAMCipla USA Inc.0580559a-783a-4a0a-8d81-ee30a29077c52024-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077534
application number: ANDA077534
CITALOPRAM HYDROBROMIDECITALOPRAMExelan Pharmaceuticals Inc.a8e8fde2-8392-4d5b-902b-e2b9dd55a02d2024-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077534
application number: ANDA077534
CitalopramCITALOPRAMA-S Medication Solutionsc91684c7-fddb-4cf0-9711-b0484c8c7e8b2024-04-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077534
application number: ANDA077534
CitalopramCITALOPRAMA-S Medication Solutions17af7a8d-ef57-4253-96ed-e457e0062eb52024-04-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077534
application number: ANDA077534
CitalopramCITALOPRAMA-S Medication Solutions04ac5286-fc2e-4990-a574-ea21131ef7312024-04-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077534
application number: ANDA077534
CitalopramCITALOPRAMAphena Pharma Solutions - Tennessee, LLC0867140e-a483-4bf7-8326-4a9730cc9d9d2020-04-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077534
application number: ANDA077534
CITALOPRAM HYDROBROMIDECITALOPRAMAphena Pharma Solutions - Tennessee, LLCd05f4e71-95f3-4f22-8b01-b21e5c19e0f22018-07-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077534
application number: ANDA077534

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76282-206-0576282020605500 TABLET in 1 BOTTLE (76282-206-05) 500 tablet2012-10-010000-00-00NoNoCurrent
76282-206-10762820206101000 TABLET in 1 BOTTLE (76282-206-10) 1000 tablet2012-10-010000-00-00NoNoCurrent
76282-206-307628202063030 TABLET in 1 BOTTLE (76282-206-30) 30 tablet2012-10-010000-00-00NoNoCurrent
76282-206-907628202069090 TABLET in 1 BOTTLE (76282-206-90) 90 tablet2017-05-010000-00-00NoNoCurrent