Citalopram

Product NDC
13107-005
11-digit product format
131070005
Labeler code
13107
Product ID
13107-005_2627f188-05c8-44ac-845e-80678a0c2fdd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Citalopram
Dosage form
TABLET
Route
ORAL
Labeler
Aurolife Pharma LLC
Application
ANDA077031
Marketing category
ANDA
Marketing start
2009-01-01
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
E
Listing certified through
2018-12-31
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 productproduct13107-005IInactivated by FDA2026-08-11
excluded packagepackage13107-00513107-005-01IInactivated by FDA2026-08-11
excluded packagepackage13107-00513107-005-05IInactivated by FDA2026-08-11
excluded packagepackage13107-00513107-005-10IInactivated by FDA2026-08-11
excluded packagepackage13107-00513107-005-30IInactivated by FDA2026-08-11
excluded packagepackage13107-00513107-005-32IInactivated by FDA2026-08-11
excluded packagepackage13107-00513107-005-60IInactivated by FDA2026-08-11
excluded packagepackage13107-00513107-005-90IInactivated 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 3 · 176 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 packagepackage13107-005-10d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage13107-005-30d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage13107-005-32d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage13107-005-90d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage13107-005-01d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage13107-005-05d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage13107-005-60d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage13107-005-10f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage13107-005-30f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage13107-005-32f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage13107-005-90f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage13107-005-01f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage13107-005-05f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage13107-005-60f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage13107-005-102ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage13107-005-302ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage13107-005-322ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage13107-005-902ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage13107-005-012ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage13107-005-052ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage13107-005-602ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage13107-005-10a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage13107-005-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage13107-005-32a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage13107-005-90a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage13107-005-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage13107-005-05a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage13107-005-60a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage13107-005-10cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage13107-005-30cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage13107-005-32cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage13107-005-90cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage13107-005-01cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage13107-005-05cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage13107-005-60cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage13107-005-10cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage13107-005-30cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage13107-005-32cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage13107-005-90cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage13107-005-01cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage13107-005-05cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage13107-005-60cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage13107-005-10302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage13107-005-30302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage13107-005-32302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage13107-005-90302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage13107-005-01302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage13107-005-05302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage13107-005-60302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage13107-005-10ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage13107-005-30ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage13107-005-32ed331223b511…672a5bd82f5f…

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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13107-005-01Citalopram100 in 1 BOTTLETABLET1002
13107-005-05Citalopram500 in 1 BOTTLETABLET5002
13107-005-10Citalopram100 in 1 CARTONTABLET1002
13107-005-10Citalopram10 in 1 BLISTER PACKTABLET102
13107-005-30Citalopram30 in 1 BOTTLETABLET302
13107-005-32Citalopram30 in 1 BLISTER PACKTABLET302
13107-005-60Citalopram60 in 1 BOTTLETABLET602
13107-005-90Citalopram90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13107-005-01EA - Each13107-005842d7a4f-994f-4b69-8e24-09641559019812012-07-24
13107-005-05EA - Each13107-005588cb88f-79b9-4094-a28d-39d4c5b811ca12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CITALOPRAM HYDROBROMIDEACTIVE INGREDIENTI1E9D14F36CITALOPRAM TABLET [AUROLIFE PHARMA LLC]2
CITALOPRAMACTIVE MOIETY0DHU5B8D6VCITALOPRAM TABLET [AUROLIFE PHARMA LLC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCITALOPRAM TABLET [AUROLIFE PHARMA LLC]2
COPOVIDONE K25-31INACTIVE INGREDIENTD9C330MD8BCITALOPRAM TABLET [AUROLIFE PHARMA LLC]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CITALOPRAM TABLET [AUROLIFE PHARMA LLC]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675CITALOPRAM TABLET [AUROLIFE PHARMA LLC]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTCITALOPRAM TABLET [AUROLIFE PHARMA LLC]2
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6CITALOPRAM TABLET [AUROLIFE PHARMA LLC]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCITALOPRAM TABLET [AUROLIFE PHARMA LLC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CITALOPRAM TABLET [AUROLIFE PHARMA LLC]2
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQCITALOPRAM TABLET [AUROLIFE PHARMA LLC]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCITALOPRAM TABLET [AUROLIFE PHARMA LLC]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCITALOPRAM TABLET [AUROLIFE PHARMA LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13107-005CITALOPRAM TABLET [AUROLIFE PHARMA LLC]2Legacy NDC, 8 package rows20120510_9f5a14c2-b460-402e-acb4-04402278e64b.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 TabletPSN9f5a14c2-b460-402e-acb4-04402278e64b2
200371citalopram 20 MG Oral TabletPSN9f5a14c2-b460-402e-acb4-04402278e64b2
309314citalopram 40 MG Oral TabletPSN9f5a14c2-b460-402e-acb4-04402278e64b2
283672citalopram 10 MG Oral TabletSCD9f5a14c2-b460-402e-acb4-04402278e64b2
200371citalopram 20 MG Oral TabletSCD9f5a14c2-b460-402e-acb4-04402278e64b2
309314citalopram 40 MG Oral TabletSCD9f5a14c2-b460-402e-acb4-04402278e64b2
283672citalopram 10 MG (as citalopram HBr 12.49 MG) Oral TabletSY9f5a14c2-b460-402e-acb4-04402278e64b2
200371citalopram 20 MG (as citalopram HBr 24.99 MG) Oral TabletSY9f5a14c2-b460-402e-acb4-04402278e64b2
309314citalopram 40 MG (as citalopram HBr 49.98 MG) Oral TabletSY9f5a14c2-b460-402e-acb4-04402278e64b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
13107-005-0113107000501100 in 1 BOTTLEHistorical
13107-005-0513107000505500 in 1 BOTTLEHistorical
13107-005-1013107000510100 in 1 CARTONHistorical
13107-005-301310700053030 in 1 BOTTLEHistorical
13107-005-321310700053230 in 1 BLISTER PACKHistorical
13107-005-601310700056060 in 1 BOTTLEHistorical
13107-005-901310700059090 in 1 BOTTLEHistorical