Home NDC 57664-509-13 citalopram hydrobromide
Product NDC 57664-509
Requested package NDC 57664-509-13
11-digit product format 576640509
Labeler code 57664
Product ID 57664-509_481269e7-a38e-4df2-ad3c-eb359baad154
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name citalopram hydrobromide
Dosage form TABLET
Route ORAL
Labeler Sun Pharmaceutical Industries, Inc.
Application ANDA077032
Marketing category ANDA
Marketing start 2015-05-29
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 No
Listing certified through 2020-12-31
Current FDA listing Historical FDA.report record 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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A077032-001 CITALOPRAM HYDROBROMIDE CITALOPRAM HYDROBROMIDE EQ 10MG BASE TABLET / ORAL 2004-11-12 A077032-002 CITALOPRAM HYDROBROMIDE CITALOPRAM HYDROBROMIDE EQ 20MG BASE TABLET / ORAL 2004-11-12 A077032-003 CITALOPRAM HYDROBROMIDE CITALOPRAM HYDROBROMIDE EQ 40MG BASE TABLET / ORAL 2004-11-12
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A077032-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE TABLET / ORAL 2004-11-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077032-002 CITALOPRAM HYDROBROMIDE EQ 20MG BASE TABLET / ORAL 2004-11-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077032-003 CITALOPRAM HYDROBROMIDE EQ 40MG BASE TABLET / ORAL 2004-11-12 84e616aacf4f…2026-08-18 06:07:40 2026-07 A077032-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE TABLET / ORAL 2004-11-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077032-002 CITALOPRAM HYDROBROMIDE EQ 20MG BASE TABLET / ORAL 2004-11-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077032-003 CITALOPRAM HYDROBROMIDE EQ 40MG BASE TABLET / ORAL 2004-11-12 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077032-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE TABLET / ORAL 2004-11-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077032-002 CITALOPRAM HYDROBROMIDE EQ 20MG BASE TABLET / ORAL 2004-11-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077032-003 CITALOPRAM HYDROBROMIDE EQ 40MG BASE TABLET / ORAL 2004-11-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077032-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE TABLET / ORAL 2004-11-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077032-002 CITALOPRAM HYDROBROMIDE EQ 20MG BASE TABLET / ORAL 2004-11-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077032-003 CITALOPRAM HYDROBROMIDE EQ 40MG BASE TABLET / ORAL 2004-11-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077032-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE TABLET / ORAL 2004-11-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077032-002 CITALOPRAM HYDROBROMIDE EQ 20MG BASE TABLET / ORAL 2004-11-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077032-003 CITALOPRAM HYDROBROMIDE EQ 40MG BASE TABLET / ORAL 2004-11-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077032-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE TABLET / ORAL 2004-11-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077032-002 CITALOPRAM HYDROBROMIDE EQ 20MG BASE TABLET / ORAL 2004-11-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077032-003 CITALOPRAM HYDROBROMIDE EQ 40MG BASE TABLET / ORAL 2004-11-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077032-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE TABLET / ORAL 2004-11-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077032-002 CITALOPRAM HYDROBROMIDE EQ 20MG BASE TABLET / ORAL 2004-11-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077032-003 CITALOPRAM HYDROBROMIDE EQ 40MG BASE TABLET / ORAL 2004-11-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077032-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE TABLET / ORAL 2004-11-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077032-002 CITALOPRAM HYDROBROMIDE EQ 20MG BASE TABLET / ORAL 2004-11-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077032-003 CITALOPRAM HYDROBROMIDE EQ 40MG BASE TABLET / ORAL 2004-11-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077032-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE TABLET / ORAL 2004-11-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077032-002 CITALOPRAM HYDROBROMIDE EQ 20MG BASE TABLET / ORAL 2004-11-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077032-003 CITALOPRAM HYDROBROMIDE EQ 40MG BASE TABLET / ORAL 2004-11-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077032-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE TABLET / ORAL 2004-11-12 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077032-002 CITALOPRAM HYDROBROMIDE EQ 20MG BASE TABLET / ORAL 2004-11-12 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077032-003 CITALOPRAM HYDROBROMIDE EQ 40MG BASE TABLET / ORAL 2004-11-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077032-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE TABLET / ORAL 2004-11-12 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077032-002 CITALOPRAM HYDROBROMIDE EQ 20MG BASE TABLET / ORAL 2004-11-12 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077032-003 CITALOPRAM HYDROBROMIDE EQ 40MG BASE TABLET / ORAL 2004-11-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077032-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE TABLET / ORAL 2004-11-12 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077032-002 CITALOPRAM HYDROBROMIDE EQ 20MG BASE TABLET / ORAL 2004-11-12 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077032-003 CITALOPRAM HYDROBROMIDE EQ 40MG BASE TABLET / ORAL 2004-11-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077032-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE TABLET / ORAL 2004-11-12 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077032-002 CITALOPRAM HYDROBROMIDE EQ 20MG BASE TABLET / ORAL 2004-11-12 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077032-003 CITALOPRAM HYDROBROMIDE EQ 40MG BASE TABLET / ORAL 2004-11-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077032-001 CITALOPRAM HYDROBROMIDE EQ 10MG BASE TABLET / ORAL 2004-11-12 301d65b070ca…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CITALOPRAM HYDROBROMIDE ACTIVE INGREDIENT I1E9D14F36 CITALOPRAM HYDROBROMIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] 13 CITALOPRAM ACTIVE MOIETY 0DHU5B8D6V CITALOPRAM HYDROBROMIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] 13 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U CITALOPRAM HYDROBROMIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] 13 COLLOIDAL SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 CITALOPRAM HYDROBROMIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] 13 COPOVIDONE K25-31 INACTIVE INGREDIENT D9C330MD8B CITALOPRAM HYDROBROMIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] 13 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 CITALOPRAM HYDROBROMIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] 13 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 CITALOPRAM HYDROBROMIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] 13 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT CITALOPRAM HYDROBROMIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] 13 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 CITALOPRAM HYDROBROMIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] 13 HYPROMELLOSE 2910 (6 MPA.S) INACTIVE INGREDIENT 0WZ8WG20P6 CITALOPRAM HYDROBROMIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] 13 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X CITALOPRAM HYDROBROMIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] 13 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CITALOPRAM HYDROBROMIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] 13 POLYETHYLENE GLYCOL 4000 INACTIVE INGREDIENT 4R4HFI6D95 CITALOPRAM HYDROBROMIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] 13 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H CITALOPRAM HYDROBROMIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] 13 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ CITALOPRAM HYDROBROMIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] 13 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP CITALOPRAM HYDROBROMIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] 13 CITALOPRAM HYDROBROMIDE ACTIVE INGREDIENT I1E9D14F36 CITALOPRAM HYDROBROMIDE TABLET [DIRECT RX] 1 CITALOPRAM HYDROBROMIDE ACTIVE INGREDIENT I1E9D14F36 CITALOPRAM HYDROBROMIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 CITALOPRAM HYDROBROMIDE ACTIVE INGREDIENT I1E9D14F36 CITALOPRAM HYDROBROMIDE TABLET [NORTHWIND PHARMACEUTICALS] 1 CITALOPRAM ACTIVE MOIETY 0DHU5B8D6V CITALOPRAM HYDROBROMIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 CITALOPRAM ACTIVE MOIETY 0DHU5B8D6V CITALOPRAM HYDROBROMIDE TABLET [NORTHWIND PHARMACEUTICALS] 1 CITALOPRAM ACTIVE MOIETY 0DHU5B8D6V CITALOPRAM HYDROBROMIDE TABLET [DIRECT RX] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U CITALOPRAM HYDROBROMIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U CITALOPRAM HYDROBROMIDE TABLET [DIRECT RX] 1 COLLOIDAL SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 CITALOPRAM HYDROBROMIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 COPOVIDONE K25-31 INACTIVE INGREDIENT D9C330MD8B CITALOPRAM HYDROBROMIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 COPOVIDONE K25-31 INACTIVE INGREDIENT D9C330MD8B CITALOPRAM HYDROBROMIDE TABLET [DIRECT RX] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 CITALOPRAM HYDROBROMIDE TABLET [DIRECT RX] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 CITALOPRAM HYDROBROMIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 CITALOPRAM HYDROBROMIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT CITALOPRAM HYDROBROMIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 HYPROMELLOSE 2910 (6 MPA.S) INACTIVE INGREDIENT 0WZ8WG20P6 CITALOPRAM HYDROBROMIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 HYPROMELLOSE 2910 (6 MPA.S) INACTIVE INGREDIENT 0WZ8WG20P6 CITALOPRAM HYDROBROMIDE TABLET [DIRECT RX] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X CITALOPRAM HYDROBROMIDE TABLET [DIRECT RX] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X CITALOPRAM HYDROBROMIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CITALOPRAM HYDROBROMIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CITALOPRAM HYDROBROMIDE TABLET [DIRECT RX] 1 POLYETHYLENE GLYCOL 4000 INACTIVE INGREDIENT 4R4HFI6D95 CITALOPRAM HYDROBROMIDE TABLET [DIRECT RX] 1 POLYETHYLENE GLYCOL 4000 INACTIVE INGREDIENT 4R4HFI6D95 CITALOPRAM HYDROBROMIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H CITALOPRAM HYDROBROMIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H CITALOPRAM HYDROBROMIDE TABLET [DIRECT RX] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 CITALOPRAM HYDROBROMIDE TABLET [DIRECT RX] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ CITALOPRAM HYDROBROMIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ CITALOPRAM HYDROBROMIDE TABLET [DIRECT RX] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP CITALOPRAM HYDROBROMIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP CITALOPRAM HYDROBROMIDE TABLET [DIRECT RX] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 57664-509 CITALOPRAM HYDROBROMIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] 18 Legacy NDC 20221209_52bf0f9e-e6c3-4dd8-921d-2e74605e07d1.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 57664-509-13 57664050913 500 TABLET in 1 BOTTLE (57664-509-13) 500 tablet 2015-05-29 0000-00-00 No No Current