Paroxetine

Product NDC
68382-099
11-digit product format
683820099
Labeler code
68382
Product ID
68382-099_c88d98d1-e370-4ad8-869a-603875f276cc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Paroxetine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Zydus Pharmaceuticals USA Inc.
Application
ANDA077584
Marketing category
ANDA
Marketing start
2007-04-13
Substance
PAROXETINE HYDROCHLORIDE HEMIHYDRATE
Active strength
30 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077584-001PAROXETINE HYDROCHLORIDEPAROXETINE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2007-03-07
A077584-002PAROXETINE HYDROCHLORIDEPAROXETINE HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2007-03-07
A077584-003PAROXETINE HYDROCHLORIDEPAROXETINE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2007-03-07
A077584-004PAROXETINE HYDROCHLORIDEPAROXETINE HYDROCHLORIDEEQ 40MG BASETABLET / ORALAB2007-03-07

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A077584-001AB
A077584-002AB
A077584-003AB
A077584-004AB

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 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A077584-001PAROXETINE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2007-03-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077584-002PAROXETINE HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2007-03-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077584-003PAROXETINE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2007-03-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077584-004PAROXETINE HYDROCHLORIDEEQ 40MG BASETABLET / ORALAB2007-03-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077584-001PAROXETINE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2007-03-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077584-002PAROXETINE HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2007-03-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077584-003PAROXETINE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2007-03-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077584-004PAROXETINE HYDROCHLORIDEEQ 40MG BASETABLET / ORALAB2007-03-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A077584-001PAROXETINE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2007-03-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077584-002PAROXETINE HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2007-03-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077584-003PAROXETINE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2007-03-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077584-004PAROXETINE HYDROCHLORIDEEQ 40MG BASETABLET / ORALAB2007-03-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077584-001PAROXETINE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2007-03-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077584-002PAROXETINE HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2007-03-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077584-003PAROXETINE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2007-03-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077584-004PAROXETINE HYDROCHLORIDEEQ 40MG BASETABLET / ORALAB2007-03-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077584-001PAROXETINE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2007-03-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077584-002PAROXETINE HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2007-03-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077584-003PAROXETINE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2007-03-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077584-004PAROXETINE HYDROCHLORIDEEQ 40MG BASETABLET / ORALAB2007-03-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077584-001PAROXETINE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2007-03-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077584-002PAROXETINE HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2007-03-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077584-003PAROXETINE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2007-03-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077584-004PAROXETINE HYDROCHLORIDEEQ 40MG BASETABLET / ORALAB2007-03-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077584-001PAROXETINE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2007-03-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077584-002PAROXETINE HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2007-03-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077584-003PAROXETINE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2007-03-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077584-004PAROXETINE HYDROCHLORIDEEQ 40MG BASETABLET / ORALAB2007-03-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077584-001PAROXETINE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2007-03-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077584-002PAROXETINE HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2007-03-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077584-003PAROXETINE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2007-03-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077584-004PAROXETINE HYDROCHLORIDEEQ 40MG BASETABLET / ORALAB2007-03-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077584-001PAROXETINE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2007-03-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077584-002PAROXETINE HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2007-03-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077584-003PAROXETINE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2007-03-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077584-004PAROXETINE HYDROCHLORIDEEQ 40MG BASETABLET / ORALAB2007-03-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077584-001PAROXETINE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2007-03-07d06236e962d9…
2024-10-29 15:01 UTC2024-10A077584-002PAROXETINE HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2007-03-07d06236e962d9…
2024-10-29 15:01 UTC2024-10A077584-003PAROXETINE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2007-03-07d06236e962d9…
2024-10-29 15:01 UTC2024-10A077584-004PAROXETINE HYDROCHLORIDEEQ 40MG BASETABLET / ORALAB2007-03-07d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A077584-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077584-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077584-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077584-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077584-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077584-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077584-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077584-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077584-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077584-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077584-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077584-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077584-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077584-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077584-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077584-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077584-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077584-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077584-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077584-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077584-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077584-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077584-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077584-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077584-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077584-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077584-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077584-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077584-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077584-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077584-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077584-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077584-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077584-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077584-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077584-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077584-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077584-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077584-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077584-004AB1d06236e962d9…

Additional Listing Data#

Finished product
Yes
Brand name base
Paroxetine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PAROXETINE HYDROCHLORIDE HEMIHYDRATE30 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
X2ELS050D8Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1738483Internal RxNorm lookup
1738495Internal RxNorm lookup
1738503Internal RxNorm lookup
1738511Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
a6bb4f0a-1555-4550-a7a4-99609674b1e7Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2ace441e-5ed1-9a56-64e5-302d887093bdProduct name720250107
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
ba9fc237-0e76-4ac8-d3c5-cdb4df9e9f7fProduct name420220524
200c61bf-0879-1df7-72b7-b72a8497b114Product name320171006
b430fc19-562d-420b-53a2-64d42b938631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68382-099-01Paroxetine100 in 1 BOTTLETABLET, FILM COATED10016
68382-099-05Paroxetine500 in 1 BOTTLETABLET, FILM COATED50016
68382-099-06Paroxetine30 in 1 BOTTLETABLET, FILM COATED3016
68382-099-10Paroxetine1000 in 1 BOTTLETABLET, FILM COATED100016
68382-099-16Paroxetine90 in 1 BOTTLETABLET, FILM COATED9016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68382-099-01EA - Each68382-099c8423a78-c212-46db-abdf-88c685670e7c12012-07-24
68382-099-05EA - Each68382-099a0aaa18e-fd29-4bca-bf3a-97062a479c4612012-07-24
68382-099-06EA - Each68382-099473f6141-8833-4282-9a5d-c0ee9348191112012-07-24
68382-099-10EA - Each68382-09982f0aa54-e119-4667-a6a2-dff84a8f300d12012-07-24
68382-099-16EA - Each68382-099299a9a52-cb88-41c3-a928-a6bc77dd10c812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PAROXETINE HYDROCHLORIDE HEMIHYDRATEACTIVE INGREDIENTX2ELS050D8PAROXETINE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]19
PAROXETINEACTIVE MOIETY41VRH5220HPAROXETINE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]19
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKPAROXETINE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]19
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JPAROXETINE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]19
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPAROXETINE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]19
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PAROXETINE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]19
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WEPAROXETINE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]19
POVIDONESINACTIVE INGREDIENTFZ989GH94EPAROXETINE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]19
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2PAROXETINE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]19
TALCINACTIVE INGREDIENT7SEV7J4R1UPAROXETINE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]19
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPAROXETINE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]19
PAROXETINE HYDROCHLORIDE HEMIHYDRATEACTIVE INGREDIENTX2ELS050D8PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]7
PAROXETINEACTIVE MOIETY41VRH5220HPAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]7
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKPAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]7
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JPAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]7
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]7
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WEPAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]7
POVIDONESINACTIVE INGREDIENTFZ989GH94EPAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]7
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]7
TALCINACTIVE INGREDIENT7SEV7J4R1UPAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]7
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]7
PAROXETINE HYDROCHLORIDE HEMIHYDRATEACTIVE INGREDIENTX2ELS050D8PAROXETINE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]6
PAROXETINEACTIVE MOIETY41VRH5220HPAROXETINE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]6
ANHYDROUS DIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENTL11K75P92JPAROXETINE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]6
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKPAROXETINE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]6
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPAROXETINE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PAROXETINE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]6
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WEPAROXETINE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]6
POVIDONEINACTIVE INGREDIENTFZ989GH94EPAROXETINE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]6
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2PAROXETINE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]6
TALCINACTIVE INGREDIENT7SEV7J4R1UPAROXETINE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]6
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPAROXETINE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]6
PAROXETINE HYDROCHLORIDEACTIVE INGREDIENT3I3T11UD2SPAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
PAROXETINE HYDROCHLORIDEACTIVE INGREDIENT3I3T11UD2SPAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
PAROXETINE HYDROCHLORIDE ANHYDROUSACTIVE INGREDIENT3I3T11UD2SPAROXETINE TABLET, FILM COATED [DIRECTRX]1
PAROXETINE HYDROCHLORIDE HEMIHYDRATEACTIVE INGREDIENTX2ELS050D8PAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
PAROXETINEACTIVE MOIETY41VRH5220HPAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
PAROXETINEACTIVE MOIETY41VRH5220HPAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
PAROXETINEACTIVE MOIETY41VRH5220HPAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
PAROXETINEACTIVE MOIETY41VRH5220HPAROXETINE TABLET, FILM COATED [DIRECTRX]1
ANHYDROUS DIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENTL11K75P92JPAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
ANHYDROUS DIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENTL11K75P92JPAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
ANHYDROUS DIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENTL11K75P92JPAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKPAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKPAROXETINE TABLET, FILM COATED [DIRECTRX]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKPAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKPAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PPAROXETINE TABLET, FILM COATED [DIRECTRX]1
HYPROMELLOSE 2910 (6 CPS)INACTIVE INGREDIENT0WZ8WG20P6PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPAROXETINE TABLET, FILM COATED [DIRECTRX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PAROXETINE TABLET, FILM COATED [DIRECTRX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
PEG-150 DISTEARATEINACTIVE INGREDIENT6F36Q0I0ACPAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WEPAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WEPAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WEPAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1APAROXETINE TABLET, FILM COATED [DIRECTRX]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EPAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EPAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EPAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2PAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2PAROXETINE TABLET, FILM COATED [DIRECTRX]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
TALCINACTIVE INGREDIENT7SEV7J4R1UPAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
TALCINACTIVE INGREDIENT7SEV7J4R1UPAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
TALCINACTIVE INGREDIENT7SEV7J4R1UPAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPAROXETINE TABLET, FILM COATED [DIRECTRX]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68382-099PAROXETINE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS USA INC.]16Current NDC, Legacy NDC, 5 package rows20250112_a6bb4f0a-1555-4550-a7a4-99609674b1e7.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 2 · 25 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ParoxetinePAROXETINEREMEDYREPACK INC.679e4b9b-0f7b-450a-aca7-1b448cccbeed2026-07-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077584
application number: ANDA077584
ParoxetinePAROXETINEHAWAII REPACK, INC.d5206418-aa7f-42dd-b977-4b9d1e4b27522026-06-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077584
application number: ANDA077584
ParoxetinePAROXETINEAmerican Health Packagingb5a8f864-a53d-48d9-aca6-6b64017fb1682026-05-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077584
application number: ANDA077584
ParoxetinePAROXETINEREMEDYREPACK INC.05ec70fd-4c65-495f-ba12-e8433a10b6552026-04-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077584
application number: ANDA077584
ParoxetinePAROXETINEREMEDYREPACK INC.c002508e-f96c-413b-b232-5d55fceeffe02026-04-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077584
application number: ANDA077584
ParoxetinePAROXETINEREMEDYREPACK INC.bc0efd3b-c6b9-4ed0-b517-6e57e4700b7b2026-03-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077584
application number: ANDA077584
PAROXETINEPAROXETINEDIRECT RX2cfe30fc-9c46-4efd-e054-00144ff8d46c2026-03-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077584
application number: ANDA077584
ParoxetinePAROXETINEA-S Medication Solutions31e4bb7c-59ab-4cbf-ba08-317c1417b28f2026-02-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077584
application number: ANDA077584
ParoxetinePAROXETINEA-S Medication Solutionsa809a6b5-18a3-4771-aaf8-7197d17435402026-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077584
application number: ANDA077584
ParoxetinePAROXETINENuCare Pharamceuticals, Inc.49dc055c-faef-0be3-e063-6394a90a934f2026-02-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077584
application number: ANDA077584
ParoxetinePAROXETINEPD-Rx Pharmaceuticals, Inc.c0acc97d-3d8d-4a7f-8acd-99050b0af2f12025-10-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077584
application number: ANDA077584
ParoxetinePAROXETINEPreferred Pharmaceuticals Inc.7d558598-6905-46da-8f34-668456c684112025-09-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077584
application number: ANDA077584
ParoxetinePAROXETINE HYDROCHLORIDEPreferred Pharmaceuticals, Inc605c1d23-c97c-4ea4-92d0-fed351de9d2e2025-09-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077584
application number: ANDA077584
ParoxetinePAROXETINEPreferred Pharmaceuticals Inc.ee38b589-e646-4203-bea5-cc3744fe17c32025-09-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077584
application number: ANDA077584
ParoxetinePAROXETINEBryant Ranch Prepack0a0f8897-2099-4038-9b96-ed9c4f0840182025-03-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077584
application number: ANDA077584
ParoxetinePAROXETINEBryant Ranch Prepack7a702760-9b72-4595-bf47-01aff786c74d2025-03-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077584
application number: ANDA077584
ParoxetinePAROXETINEBryant Ranch Prepack07f245c5-fcb0-3008-d69e-10290cadbfa62025-03-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077584
application number: ANDA077584
ParoxetinePAROXETINEAsclemed USA, Inc.4acd3e7a-4f19-4428-9452-48ce370cb3db2025-02-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077584
application number: ANDA077584
ParoxetinePAROXETINEDirect_Rxfea936a5-fdeb-e4fb-e053-6294a90a89952025-01-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077584
application number: ANDA077584
ParoxetinePAROXETINEZydus Pharmaceuticals USA Inc.a6bb4f0a-1555-4550-a7a4-99609674b1e72025-01-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077584
application number: ANDA077584
ndc (product): 68382-099

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1738483PARoxetine HCl 10 MG Oral TabletPSNb5a8f864-a53d-48d9-aca6-6b64017fb16818
1738495PARoxetine HCl 20 MG Oral TabletPSNb5a8f864-a53d-48d9-aca6-6b64017fb16818
1738503PARoxetine HCl 30 MG Oral TabletPSNb5a8f864-a53d-48d9-aca6-6b64017fb16818
1738511PARoxetine HCl 40 MG Oral TabletPSNb5a8f864-a53d-48d9-aca6-6b64017fb16818
1738483paroxetine hydrochloride 10 MG Oral TabletSCDb5a8f864-a53d-48d9-aca6-6b64017fb16818
1738495paroxetine hydrochloride 20 MG Oral TabletSCDb5a8f864-a53d-48d9-aca6-6b64017fb16818
1738503paroxetine hydrochloride 30 MG Oral TabletSCDb5a8f864-a53d-48d9-aca6-6b64017fb16818
1738511paroxetine hydrochloride 40 MG Oral TabletSCDb5a8f864-a53d-48d9-aca6-6b64017fb16818
1738503PARoxetine HCl 30 MG Oral TabletPSN0a0f8897-2099-4038-9b96-ed9c4f08401817
1738503paroxetine hydrochloride 30 MG Oral TabletSCD0a0f8897-2099-4038-9b96-ed9c4f08401817
1738483PARoxetine HCl 10 MG Oral TabletPSNa6bb4f0a-1555-4550-a7a4-99609674b1e716
1738495PARoxetine HCl 20 MG Oral TabletPSNa6bb4f0a-1555-4550-a7a4-99609674b1e716
1738503PARoxetine HCl 30 MG Oral TabletPSNa6bb4f0a-1555-4550-a7a4-99609674b1e716
1738511PARoxetine HCl 40 MG Oral TabletPSNa6bb4f0a-1555-4550-a7a4-99609674b1e716
1738483paroxetine hydrochloride 10 MG Oral TabletSCDa6bb4f0a-1555-4550-a7a4-99609674b1e716
1738495paroxetine hydrochloride 20 MG Oral TabletSCDa6bb4f0a-1555-4550-a7a4-99609674b1e716
1738503paroxetine hydrochloride 30 MG Oral TabletSCDa6bb4f0a-1555-4550-a7a4-99609674b1e716
1738511paroxetine hydrochloride 40 MG Oral TabletSCDa6bb4f0a-1555-4550-a7a4-99609674b1e716
1738503PARoxetine HCl 30 MG Oral TabletPSN679e4b9b-0f7b-450a-aca7-1b448cccbeed15
1738503paroxetine hydrochloride 30 MG Oral TabletSCD679e4b9b-0f7b-450a-aca7-1b448cccbeed15
1738503PARoxetine HCl 30 MG Oral TabletPSNee38b589-e646-4203-bea5-cc3744fe17c38
1738503paroxetine hydrochloride 30 MG Oral TabletSCDee38b589-e646-4203-bea5-cc3744fe17c38
1738503PARoxetine HCl 30 MG Oral TabletPSN79b0eb99-95f8-4db4-ba30-503f32538ab83
1738503paroxetine hydrochloride 30 MG Oral TabletSCD79b0eb99-95f8-4db4-ba30-503f32538ab83
1738483PARoxetine HCl 10 MG Oral TabletPSN4acd3e7a-4f19-4428-9452-48ce370cb3db2
1738495PARoxetine HCl 20 MG Oral TabletPSN4acd3e7a-4f19-4428-9452-48ce370cb3db2
1738503PARoxetine HCl 30 MG Oral TabletPSN4acd3e7a-4f19-4428-9452-48ce370cb3db2
1738511PARoxetine HCl 40 MG Oral TabletPSN4acd3e7a-4f19-4428-9452-48ce370cb3db2
1738483paroxetine hydrochloride 10 MG Oral TabletSCD4acd3e7a-4f19-4428-9452-48ce370cb3db2
1738495paroxetine hydrochloride 20 MG Oral TabletSCD4acd3e7a-4f19-4428-9452-48ce370cb3db2
1738503paroxetine hydrochloride 30 MG Oral TabletSCD4acd3e7a-4f19-4428-9452-48ce370cb3db2
1738511paroxetine hydrochloride 40 MG Oral TabletSCD4acd3e7a-4f19-4428-9452-48ce370cb3db2
1738483PARoxetine HCl 10 MG Oral TabletPSN0d4fb45b-e45b-4519-96a3-a8a106450f871
1738483PARoxetine HCl 10 MG Oral TabletPSN32fd11aa-2996-496d-ac3b-76a6afe22e3c1
1738495PARoxetine HCl 20 MG Oral TabletPSN0d4fb45b-e45b-4519-96a3-a8a106450f871
1738495PARoxetine HCl 20 MG Oral TabletPSN32fd11aa-2996-496d-ac3b-76a6afe22e3c1
1738503PARoxetine HCl 30 MG Oral TabletPSN32fd11aa-2996-496d-ac3b-76a6afe22e3c1
1738503PARoxetine HCl 30 MG Oral TabletPSN9914d93a-7315-4451-9c00-1e2cb78bbe311
1738503PARoxetine HCl 30 MG Oral TabletPSN0d4fb45b-e45b-4519-96a3-a8a106450f871
1738511PARoxetine HCl 40 MG Oral TabletPSN32fd11aa-2996-496d-ac3b-76a6afe22e3c1
1738511PARoxetine HCl 40 MG Oral TabletPSN0d4fb45b-e45b-4519-96a3-a8a106450f871
1738483paroxetine hydrochloride 10 MG Oral TabletSCD0d4fb45b-e45b-4519-96a3-a8a106450f871
1738483paroxetine hydrochloride 10 MG Oral TabletSCD32fd11aa-2996-496d-ac3b-76a6afe22e3c1
1738495paroxetine hydrochloride 20 MG Oral TabletSCD32fd11aa-2996-496d-ac3b-76a6afe22e3c1
1738495paroxetine hydrochloride 20 MG Oral TabletSCD0d4fb45b-e45b-4519-96a3-a8a106450f871
1738503paroxetine hydrochloride 30 MG Oral TabletSCD32fd11aa-2996-496d-ac3b-76a6afe22e3c1
1738503paroxetine hydrochloride 30 MG Oral TabletSCD0d4fb45b-e45b-4519-96a3-a8a106450f871
1738503paroxetine hydrochloride 30 MG Oral TabletSCD9914d93a-7315-4451-9c00-1e2cb78bbe311
1738511paroxetine hydrochloride 40 MG Oral TabletSCD32fd11aa-2996-496d-ac3b-76a6afe22e3c1
1738511paroxetine hydrochloride 40 MG Oral TabletSCD0d4fb45b-e45b-4519-96a3-a8a106450f871

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68382-099-0168382009901100 TABLET, FILM COATED in 1 BOTTLE (68382-099-01) 2007-04-130000-00-00NoNoCurrent
68382-099-0568382009905500 TABLET, FILM COATED in 1 BOTTLE (68382-099-05) 2007-04-130000-00-00NoNoCurrent
68382-099-066838200990630 TABLET, FILM COATED in 1 BOTTLE (68382-099-06) 2007-04-130000-00-00NoNoCurrent
68382-099-10683820099101000 TABLET, FILM COATED in 1 BOTTLE (68382-099-10) 2007-04-130000-00-00NoNoCurrent
68382-099-166838200991690 TABLET, FILM COATED in 1 BOTTLE (68382-099-16) 2007-04-130000-00-00NoNoCurrent