Citalopram Hydrobromide

Product NDC
33261-027
11-digit product format
332610027
Labeler code
33261
Product ID
33261-027_11d5faa0-145f-45b8-a386-b17d0ef240d0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Citalopram Hydrobromide
Dosage form
TABLET
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA078216
Marketing category
ANDA
Marketing start
2007-10-18
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
2019-12-31
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 productproduct33261-027IInactivated by FDA2026-10-05
excluded packagepackage33261-02733261-027-02IInactivated by FDA2026-10-05
excluded packagepackage33261-02733261-027-30IInactivated by FDA2026-10-05
excluded packagepackage33261-02733261-027-60IInactivated by FDA2026-10-05
excluded packagepackage33261-02733261-027-90IInactivated 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 2 · 105 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 packagepackage33261-027-30d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage33261-027-02d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage33261-027-60d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage33261-027-90d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage33261-027-30f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage33261-027-02f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage33261-027-60f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage33261-027-90f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage33261-027-302ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage33261-027-022ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage33261-027-602ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage33261-027-902ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage33261-027-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage33261-027-02a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage33261-027-60a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage33261-027-90a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage33261-027-30cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage33261-027-02cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage33261-027-60cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage33261-027-90cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage33261-027-30cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage33261-027-02cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage33261-027-60cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage33261-027-90cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage33261-027-30302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage33261-027-02302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage33261-027-60302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage33261-027-90302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage33261-027-30ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage33261-027-02ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage33261-027-60ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage33261-027-90ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage33261-027-300efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage33261-027-020efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage33261-027-600efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage33261-027-900efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage33261-027-30ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage33261-027-02ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage33261-027-60ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage33261-027-90ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage33261-027-30367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage33261-027-02367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage33261-027-60367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage33261-027-90367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage33261-027-30557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage33261-027-02557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage33261-027-60557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage33261-027-90557ba5c1ecfa…9c80585c8c6e…

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
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 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A078216-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORALAB2007-03-2784e616aacf4f…
2026-09-14 22:38:342026-08A078216-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2007-03-2784e616aacf4f…
2026-09-14 22:38:342026-08A078216-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2007-03-2784e616aacf4f…
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…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A078216-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A078216-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A078216-003AB184e616aacf4f…
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…

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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-027-02Citalopram Hydrobromide120 in 1 BOTTLE, PLASTICTABLET1201
33261-027-30Citalopram Hydrobromide30 in 1 BOTTLE, PLASTICTABLET301
33261-027-60Citalopram Hydrobromide60 in 1 BOTTLE, PLASTICTABLET601
33261-027-90Citalopram Hydrobromide90 in 1 BOTTLE, PLASTICTABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33261-027-30EA - Each33261-027689d4502-6eca-4ad8-a5eb-465fb27d715212015-10-02
33261-027-60EA - Each33261-02788ae0b5d-6098-422a-93c1-26a1a3bf29e812015-10-02
33261-027-90EA - Each33261-027a2dc46a4-aa7f-4494-ae89-0037fb7a432e12015-10-02

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-027CITALOPRAM HYDROBROMIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 4 package rows20140102_16715e29-86e8-48b3-8c12-da70e5893901.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 2 of 2 · 38 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Citalopram HydrobromideCITALOPRAM HYDROBROMIDENorthwind Health Company, LLCc133fc77-6c8a-d2b1-e053-2995a90ab5f72025-12-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078216
application number: ANDA078216
CitalopramCITALOPRAMAdvanced Rx of Tennessee, LLC434094b4-fa3b-385a-e063-6394a90ac6382025-11-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078216
application number: ANDA078216
Citalopram HydrobromideCITALOPRAM HYDROBROMIDENuCare Pharmaceuticals,Inc.c577b306-ee7c-8364-e053-2a95a90abb132025-01-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078216
application number: ANDA078216
Citalopram HydrobromideCITALOPRAM HYDROBROMIDENuCare Pharmaceuticals,Inc.c584909b-e7b2-7108-e053-2995a90a2f542024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078216
application number: ANDA078216
CitalopramCITALOPRAMAdvanced Rx of Tennessee, LLCb3541f26-dc8d-6591-e053-2995a90a23d92024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078216
application number: ANDA078216
Citalopram HydrobromideCITALOPRAM HYDROBROMIDEQuality Care Products, LLC6fc110ba-87e7-404e-9e00-b680f354c7b02024-12-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078216
application number: ANDA078216
Citalopram HydrobromideCITALOPRAM HYDROBROMIDEQuality Care Products, LLCe22fe468-5d9e-4ec7-a69b-4988e0b8acbd2024-12-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078216
application number: ANDA078216
Citalopram HydrobromideCITALOPRAM HYDROBROMIDEBryant Ranch Prepack8719bd44-36b6-468d-9203-8c53a26451842024-11-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078216
application number: ANDA078216
Citalopram HydrobromideCITALOPRAM HYDROBROMIDEProficient Rx LP1a136cc3-d655-4f3c-8710-2603dc0084922024-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078216
application number: ANDA078216
Citalopram HydrobromideCITALOPRAM HYDROBROMIDEBryant Ranch Prepack15cb00da-4435-4930-90d0-faadf2739a5c2024-10-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078216
application number: ANDA078216
Citalopram HydrobromideCITALOPRAM HYDROBROMIDEA-S Medication Solutions05421bee-f746-418e-bb9c-ab44a89b567d2024-09-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078216
application number: ANDA078216
Citalopram HydrobromideCITALOPRAM HYDROBROMIDENuCare Pharmaceuticals, Inc.4f45c818-b324-6ca6-e054-00144ff8d46c2024-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078216
application number: ANDA078216
Citalopram HydrobromideCITALOPRAM HYDROBROMIDENuCare Pharmaceuticals,Inc.579836d8-64ed-de2d-e053-2a91aa0a83922024-07-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078216
application number: ANDA078216
Citalopram HydrobromideCITALOPRAM HYDROBROMIDENuCare Pharmaceuticals,Inc.549a5b3f-4928-1ae5-e054-00144ff8d46c2024-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078216
application number: ANDA078216
Citalopram HydrobromideCITALOPRAM HYDROBROMIDENuCare Pharmaceuticals,Inc.9987a273-e6d7-54cd-e053-2a95a90a0aaa2024-06-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078216
application number: ANDA078216
Citalopram HydrobromideCITALOPRAM HYDROBROMIDEA-S Medication Solutions9059c8f1-8755-492d-aba2-5f5088ce69d32023-12-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078216
application number: ANDA078216
Citalopram HydrobromideCITALOPRAM HYDROBROMIDEA-S Medication Solutions9d2f8f9f-9710-48e0-bc18-105a2af1073b2023-12-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078216
application number: ANDA078216
Citalopram HydrobromideCITALOPRAM HYDROBROMIDEProficient Rx LP4eb71151-241a-476e-a495-4a021bc55bda2023-02-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078216
application number: ANDA078216

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283672citalopram 10 MG Oral TabletPSN16715e29-86e8-48b3-8c12-da70e58939011
200371citalopram 20 MG Oral TabletPSN16715e29-86e8-48b3-8c12-da70e58939011
309314citalopram 40 MG Oral TabletPSN16715e29-86e8-48b3-8c12-da70e58939011
283672citalopram 10 MG Oral TabletSCD16715e29-86e8-48b3-8c12-da70e58939011
200371citalopram 20 MG Oral TabletSCD16715e29-86e8-48b3-8c12-da70e58939011
309314citalopram 40 MG Oral TabletSCD16715e29-86e8-48b3-8c12-da70e58939011
283672citalopram 10 MG (as citalopram HBr 12.49 MG) Oral TabletSY16715e29-86e8-48b3-8c12-da70e58939011
200371citalopram 20 MG (as citalopram HBr 24.99 MG) Oral TabletSY16715e29-86e8-48b3-8c12-da70e58939011
309314citalopram 40 MG (as citalopram HBr 49.98 MG) Oral TabletSY16715e29-86e8-48b3-8c12-da70e58939011

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33261-027-0233261002702120 in 1 BOTTLE, PLASTICHistorical
33261-027-303326100273030 in 1 BOTTLE, PLASTICHistorical
33261-027-603326100276060 in 1 BOTTLE, PLASTICHistorical
33261-027-903326100279090 in 1 BOTTLE, PLASTICHistorical