Home NDC 21695-102 Paroxetine
Product NDC 21695-102
11-digit product format 216950102
Labeler code 21695
Product ID 21695-102_0d4fb45b-e45b-4519-96a3-a8a106450f87
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Paroxetine Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Rebel Distributors Corp
Application ANDA077854
Marketing category ANDA
Marketing start 2007-04-13
Marketing end 0000-00-00
Substance PAROXETINE HYDROCHLORIDE
Active strength 20 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
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 · 88 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 5 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A077854-001 PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.125MG TABLET / ORAL 2010-10-08 A077854-002 PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.25MG TABLET / ORAL 2010-10-08 A077854-003 PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.5MG TABLET / ORAL 2010-10-08 A077854-004 PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 1MG TABLET / ORAL 2010-10-08 A077854-005 PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 1.5MG TABLET / ORAL 2010-10-08
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 6 · 215 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 A077854-001 PRAMIPEXOLE DIHYDROCHLORIDE 0.125MG TABLET / ORAL 2010-10-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077854-002 PRAMIPEXOLE DIHYDROCHLORIDE 0.25MG TABLET / ORAL 2010-10-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077854-003 PRAMIPEXOLE DIHYDROCHLORIDE 0.5MG TABLET / ORAL 2010-10-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077854-004 PRAMIPEXOLE DIHYDROCHLORIDE 1MG TABLET / ORAL 2010-10-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077854-005 PRAMIPEXOLE DIHYDROCHLORIDE 1.5MG TABLET / ORAL 2010-10-08 84e616aacf4f…2026-08-18 06:07:40 2026-07 A077854-001 PRAMIPEXOLE DIHYDROCHLORIDE 0.125MG TABLET / ORAL 2010-10-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077854-002 PRAMIPEXOLE DIHYDROCHLORIDE 0.25MG TABLET / ORAL 2010-10-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077854-003 PRAMIPEXOLE DIHYDROCHLORIDE 0.5MG TABLET / ORAL 2010-10-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077854-004 PRAMIPEXOLE DIHYDROCHLORIDE 1MG TABLET / ORAL 2010-10-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077854-005 PRAMIPEXOLE DIHYDROCHLORIDE 1.5MG TABLET / ORAL 2010-10-08 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077854-001 PRAMIPEXOLE DIHYDROCHLORIDE 0.125MG TABLET / ORAL 2010-10-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077854-002 PRAMIPEXOLE DIHYDROCHLORIDE 0.25MG TABLET / ORAL 2010-10-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077854-003 PRAMIPEXOLE DIHYDROCHLORIDE 0.5MG TABLET / ORAL 2010-10-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077854-004 PRAMIPEXOLE DIHYDROCHLORIDE 1MG TABLET / ORAL 2010-10-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077854-005 PRAMIPEXOLE DIHYDROCHLORIDE 1.5MG TABLET / ORAL 2010-10-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077854-001 PRAMIPEXOLE DIHYDROCHLORIDE 0.125MG TABLET / ORAL 2010-10-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077854-002 PRAMIPEXOLE DIHYDROCHLORIDE 0.25MG TABLET / ORAL 2010-10-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077854-003 PRAMIPEXOLE DIHYDROCHLORIDE 0.5MG TABLET / ORAL 2010-10-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077854-004 PRAMIPEXOLE DIHYDROCHLORIDE 1MG TABLET / ORAL 2010-10-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077854-005 PRAMIPEXOLE DIHYDROCHLORIDE 1.5MG TABLET / ORAL 2010-10-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077854-001 PRAMIPEXOLE DIHYDROCHLORIDE 0.125MG TABLET / ORAL 2010-10-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077854-002 PRAMIPEXOLE DIHYDROCHLORIDE 0.25MG TABLET / ORAL 2010-10-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077854-003 PRAMIPEXOLE DIHYDROCHLORIDE 0.5MG TABLET / ORAL 2010-10-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077854-004 PRAMIPEXOLE DIHYDROCHLORIDE 1MG TABLET / ORAL 2010-10-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077854-005 PRAMIPEXOLE DIHYDROCHLORIDE 1.5MG TABLET / ORAL 2010-10-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077854-001 PRAMIPEXOLE DIHYDROCHLORIDE 0.125MG TABLET / ORAL 2010-10-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077854-002 PRAMIPEXOLE DIHYDROCHLORIDE 0.25MG TABLET / ORAL 2010-10-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077854-003 PRAMIPEXOLE DIHYDROCHLORIDE 0.5MG TABLET / ORAL 2010-10-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077854-004 PRAMIPEXOLE DIHYDROCHLORIDE 1MG TABLET / ORAL 2010-10-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077854-005 PRAMIPEXOLE DIHYDROCHLORIDE 1.5MG TABLET / ORAL 2010-10-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077854-001 PRAMIPEXOLE DIHYDROCHLORIDE 0.125MG TABLET / ORAL 2010-10-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077854-002 PRAMIPEXOLE DIHYDROCHLORIDE 0.25MG TABLET / ORAL 2010-10-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077854-003 PRAMIPEXOLE DIHYDROCHLORIDE 0.5MG TABLET / ORAL 2010-10-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077854-004 PRAMIPEXOLE DIHYDROCHLORIDE 1MG TABLET / ORAL 2010-10-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077854-005 PRAMIPEXOLE DIHYDROCHLORIDE 1.5MG TABLET / ORAL 2010-10-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077854-001 PRAMIPEXOLE DIHYDROCHLORIDE 0.125MG TABLET / ORAL 2010-10-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077854-002 PRAMIPEXOLE DIHYDROCHLORIDE 0.25MG TABLET / ORAL 2010-10-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077854-003 PRAMIPEXOLE DIHYDROCHLORIDE 0.5MG TABLET / ORAL 2010-10-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077854-004 PRAMIPEXOLE DIHYDROCHLORIDE 1MG TABLET / ORAL 2010-10-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077854-005 PRAMIPEXOLE DIHYDROCHLORIDE 1.5MG TABLET / ORAL 2010-10-08 03ed91905a0d…
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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 21695-102-30 Paroxetine 30 in 1 BOTTLE TABLET, FILM COATED 30 1 21695-102-60 Paroxetine 60 in 1 BOTTLE TABLET, FILM COATED 60 1 21695-102-90 Paroxetine 90 in 1 BOTTLE TABLET, FILM COATED 90 1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded PAROXETINE HYDROCHLORIDE ACTIVE INGREDIENT 3I3T11UD2S PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 PAROXETINE ACTIVE MOIETY 41VRH5220H PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 ANHYDROUS DIBASIC CALCIUM PHOSPHATE INACTIVE INGREDIENT L11K75P92J PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 POLYETHYLENE GLYCOL 6000 INACTIVE INGREDIENT 30IQX730WE PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 POVIDONE INACTIVE INGREDIENT FZ989GH94E PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 21695-102 PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 Legacy NDC, 3 package rows 20110113_0d4fb45b-e45b-4519-96a3-a8a106450f87.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 21695-102-30 21695010230 30 in 1 BOTTLE Historical 21695-102-60 21695010260 60 in 1 BOTTLE Historical 21695-102-90 21695010290 90 in 1 BOTTLE Historical