Citalopram

Product NDC
0615-6512
11-digit product format
006156512
Labeler code
0615
Product ID
0615-6512_7d3a4bb2-fce0-43f1-88e3-e52ccf8133ec
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Citalopram
Dosage form
TABLET
Route
ORAL
Labeler
NCS HealthCare of KY, Inc dba Vangard Labs
Application
ANDA077048
Marketing category
ANDA
Marketing start
2007-11-08
Marketing end
0000-00-00
Substance
CITALOPRAM HYDROBROMIDE
Active strength
40 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 · 8 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0615-6512DDiscontinued by firm2026-10-15
excluded productproduct0615-6512DDiscontinued by firm2026-10-15
excluded packagepackage0615-65120615-6512-05DDiscontinued by firm2026-10-15
excluded packagepackage0615-65120615-6512-31DDiscontinued by firm2026-10-15
excluded packagepackage0615-65120615-6512-39DDiscontinued by firm2026-10-15
excluded packagepackage0615-65120615-6512-05DDiscontinued by firm2026-10-15
excluded packagepackage0615-65120615-6512-31DDiscontinued by firm2026-10-15
excluded packagepackage0615-65120615-6512-39DDiscontinued by firm2026-10-15

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 · 108 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 productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0615-6512-39d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0615-6512-39d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0615-6512-05d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0615-6512-31d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0615-6512-05d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0615-6512-31d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0615-6512-39f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0615-6512-39f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0615-6512-05f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0615-6512-31f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0615-6512-05f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0615-6512-31f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0615-6512-392ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0615-6512-392ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0615-6512-052ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0615-6512-312ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0615-6512-052ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0615-6512-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0615-6512-39a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0615-6512-39a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0615-6512-05a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0615-6512-31a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0615-6512-05a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0615-6512-31a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0615-6512-39cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0615-6512-39cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0615-6512-05cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0615-6512-31cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0615-6512-05cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0615-6512-31cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0615-6512-39cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0615-6512-39cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0615-6512-05cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0615-6512-31cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0615-6512-05cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0615-6512-31cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0615-6512-39302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0615-6512-39302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0615-6512-05302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0615-6512-31302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0615-6512-05302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0615-6512-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0615-6512-39ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0615-6512-39ed331223b511…672a5bd82f5f…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A077048-001CITALOPRAM HYDROBROMIDECITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORAL2004-11-16
A077048-002CITALOPRAM HYDROBROMIDECITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORAL2004-11-16
A077048-003CITALOPRAM HYDROBROMIDECITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORAL2004-11-16

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 · 132 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A077048-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORAL2004-11-16c2088c7a36db…
2026-10-15 13:18:302026-09A077048-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORAL2004-11-16c2088c7a36db…
2026-10-15 13:18:302026-09A077048-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORAL2004-11-16c2088c7a36db…
2026-09-14 22:38:342026-08A077048-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORAL2004-11-1684e616aacf4f…
2026-09-14 22:38:342026-08A077048-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORAL2004-11-1684e616aacf4f…
2026-09-14 22:38:342026-08A077048-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORAL2004-11-1684e616aacf4f…
2026-08-18 06:07:402026-07A077048-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORAL2004-11-16caaa826d4ba7…
2026-08-18 06:07:402026-07A077048-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORAL2004-11-16caaa826d4ba7…
2026-08-18 06:07:402026-07A077048-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORAL2004-11-16caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077048-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORAL2004-11-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077048-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORAL2004-11-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077048-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORAL2004-11-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077048-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORAL2004-11-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077048-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORAL2004-11-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077048-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORAL2004-11-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A077048-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORAL2004-11-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077048-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORAL2004-11-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077048-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORAL2004-11-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077048-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORAL2004-11-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077048-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORAL2004-11-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077048-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORAL2004-11-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077048-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORAL2004-11-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077048-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORAL2004-11-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077048-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORAL2004-11-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077048-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORAL2004-11-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077048-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORAL2004-11-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077048-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORAL2004-11-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077048-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORAL2004-11-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077048-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORAL2004-11-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077048-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORAL2004-11-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077048-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORAL2004-11-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077048-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORAL2004-11-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077048-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORAL2004-11-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077048-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORAL2004-11-16d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077048-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORAL2004-11-16d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077048-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORAL2004-11-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077048-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORAL2004-11-16d06236e962d9…
2024-10-29 15:01 UTC2024-10A077048-002CITALOPRAM HYDROBROMIDEEQ 20MG BASETABLET / ORAL2004-11-16d06236e962d9…
2024-10-29 15:01 UTC2024-10A077048-003CITALOPRAM HYDROBROMIDEEQ 40MG BASETABLET / ORAL2004-11-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077048-001CITALOPRAM HYDROBROMIDEEQ 10MG BASETABLET / ORAL2004-11-1679d66fd596c7…

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 2 · 78 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A077048-002AB16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A077048-003AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A077048-001AB11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A077048-002AB11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A077048-003AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A077048-001AB1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A077048-002AB1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A077048-003AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A077048-001AB1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A077048-002AB1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A077048-003AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A077048-001AB19b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A077048-002AB19b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A077048-003AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A077048-001AB1a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A077048-002AB1a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A077048-003AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A077048-001AB13f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A077048-002AB13f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A077048-003AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A077048-001AB1053a50430f4f…
2023-05-13 08:27 UTC2023-05A077048-002AB1053a50430f4f…
2023-05-13 08:27 UTC2023-05A077048-003AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A077048-001AB13bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01A077048-002AB13bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01A077048-003AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A077048-001AB13a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A077048-002AB13a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A077048-003AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A077048-001AB1f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A077048-002AB1f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A077048-003AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A077048-001AB1e64feba35796…
2022-09-29 23:25 UTC2022-09A077048-002AB1e64feba35796…
2022-09-29 23:25 UTC2022-09A077048-003AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A077048-001AB1cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A077048-002AB1cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A077048-003AB1cb3db0bc1861…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
0615-6512-052021-04-09Citalopram Tablets
0615-6512-312021-04-09Citalopram Tablets
0615-6512-392021-04-09Citalopram Tablets
0615-6512-052020-01-31Citalopram Tablets
0615-6512-312020-01-31Citalopram Tablets
0615-6512-392020-01-31Citalopram Tablets

DailyMed Socrata Ingredients#