Home NDC 63187-340 Olanzapine
Product NDC 63187-340
11-digit product format 631870340
Labeler code 63187
Product ID 63187-340_c6e1cbe2-4d81-4b7c-b948-d64d9b3527a7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Olanzapine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Proficient Rx LP
Application ANDA202862
Marketing category ANDA
Marketing start 2014-08-22
Substance OLANZAPINE
Active strength 5 mg/1
Pharmacologic classes Atypical Antipsychotic [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 6 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A202862-001 OLANZAPINE OLANZAPINE 2.5MG TABLET / ORAL AB 2014-08-15 A202862-002 OLANZAPINE OLANZAPINE 5MG TABLET / ORAL AB 2014-08-15 A202862-003 OLANZAPINE OLANZAPINE 7.5MG TABLET / ORAL AB 2014-08-15 A202862-004 OLANZAPINE OLANZAPINE 10MG TABLET / ORAL AB 2014-08-15 A202862-005 OLANZAPINE OLANZAPINE 15MG TABLET / ORAL AB 2014-08-15 A202862-006 OLANZAPINE OLANZAPINE 20MG TABLET / ORAL AB 2014-08-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 6 matching rows.
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 7 · 258 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 A202862-001 OLANZAPINE 2.5MG TABLET / ORAL AB 2014-08-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 A202862-002 OLANZAPINE 5MG TABLET / ORAL AB 2014-08-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 A202862-003 OLANZAPINE 7.5MG TABLET / ORAL AB 2014-08-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 A202862-004 OLANZAPINE 10MG TABLET / ORAL AB 2014-08-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 A202862-005 OLANZAPINE 15MG TABLET / ORAL AB 2014-08-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 A202862-006 OLANZAPINE 20MG TABLET / ORAL AB 2014-08-15 84e616aacf4f…2026-08-18 06:07:40 2026-07 A202862-001 OLANZAPINE 2.5MG TABLET / ORAL AB 2014-08-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202862-002 OLANZAPINE 5MG TABLET / ORAL AB 2014-08-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202862-003 OLANZAPINE 7.5MG TABLET / ORAL AB 2014-08-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202862-004 OLANZAPINE 10MG TABLET / ORAL AB 2014-08-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202862-005 OLANZAPINE 15MG TABLET / ORAL AB 2014-08-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202862-006 OLANZAPINE 20MG TABLET / ORAL AB 2014-08-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A202862-001 OLANZAPINE 2.5MG TABLET / ORAL AB 2014-08-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202862-002 OLANZAPINE 5MG TABLET / ORAL AB 2014-08-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202862-003 OLANZAPINE 7.5MG TABLET / ORAL AB 2014-08-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202862-004 OLANZAPINE 10MG TABLET / ORAL AB 2014-08-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202862-005 OLANZAPINE 15MG TABLET / ORAL AB 2014-08-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202862-006 OLANZAPINE 20MG TABLET / ORAL AB 2014-08-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202862-001 OLANZAPINE 2.5MG TABLET / ORAL AB 2014-08-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202862-002 OLANZAPINE 5MG TABLET / ORAL AB 2014-08-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202862-003 OLANZAPINE 7.5MG TABLET / ORAL AB 2014-08-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202862-004 OLANZAPINE 10MG TABLET / ORAL AB 2014-08-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202862-005 OLANZAPINE 15MG TABLET / ORAL AB 2014-08-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202862-006 OLANZAPINE 20MG TABLET / ORAL AB 2014-08-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202862-001 OLANZAPINE 2.5MG TABLET / ORAL AB 2014-08-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202862-002 OLANZAPINE 5MG TABLET / ORAL AB 2014-08-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202862-003 OLANZAPINE 7.5MG TABLET / ORAL AB 2014-08-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202862-004 OLANZAPINE 10MG TABLET / ORAL AB 2014-08-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202862-005 OLANZAPINE 15MG TABLET / ORAL AB 2014-08-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202862-006 OLANZAPINE 20MG TABLET / ORAL AB 2014-08-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202862-001 OLANZAPINE 2.5MG TABLET / ORAL AB 2014-08-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202862-002 OLANZAPINE 5MG TABLET / ORAL AB 2014-08-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202862-003 OLANZAPINE 7.5MG TABLET / ORAL AB 2014-08-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202862-004 OLANZAPINE 10MG TABLET / ORAL AB 2014-08-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202862-005 OLANZAPINE 15MG TABLET / ORAL AB 2014-08-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202862-006 OLANZAPINE 20MG TABLET / ORAL AB 2014-08-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202862-001 OLANZAPINE 2.5MG TABLET / ORAL AB 2014-08-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202862-002 OLANZAPINE 5MG TABLET / ORAL AB 2014-08-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202862-003 OLANZAPINE 7.5MG TABLET / ORAL AB 2014-08-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202862-004 OLANZAPINE 10MG TABLET / ORAL AB 2014-08-15 b8a1b40f171c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 7 · 258 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Olanzapine
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OLANZAPINE 5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination N7U69T4SZR Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 312078 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63187-340-06 Olanzapine 6 in 1 BOTTLE TABLET, FILM COATED 6 5 63187-340-30 Olanzapine 30 in 1 BOTTLE TABLET, FILM COATED 30 5 63187-340-60 Olanzapine 60 in 1 BOTTLE TABLET, FILM COATED 60 5 63187-340-90 Olanzapine 90 in 1 BOTTLE TABLET, FILM COATED 90 5
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded OLANZAPINE ACTIVE INGREDIENT N7U69T4SZR OLANZAPINE TABLET, FILM COATED [PROFICIENT RX LP] 1 OLANZAPINE ACTIVE MOIETY N7U69T4SZR OLANZAPINE TABLET, FILM COATED [PROFICIENT RX LP] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U OLANZAPINE TABLET, FILM COATED [PROFICIENT RX LP] 1 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK OLANZAPINE TABLET, FILM COATED [PROFICIENT RX LP] 1 HYDROXYPROPYL CELLULOSE (TYPE H) INACTIVE INGREDIENT RFW2ET671P OLANZAPINE TABLET, FILM COATED [PROFICIENT RX LP] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 OLANZAPINE TABLET, FILM COATED [PROFICIENT RX LP] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP OLANZAPINE TABLET, FILM COATED [PROFICIENT RX LP] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63187-340 OLANZAPINE TABLET, FILM COATED [PROFICIENT RX LP] 5 Current NDC, Legacy NDC, 4 package rows 20230225_ce66d545-015b-41d5-80c3-964d78e36bfd.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 2 of 2 · 23 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 63187-340-06 63187034006 6 TABLET, FILM COATED in 1 BOTTLE (63187-340-06) 2023-02-21 No No Current 63187-340-30 63187034030 30 TABLET, FILM COATED in 1 BOTTLE (63187-340-30) 2015-02-02 0000-00-00 No No Current 63187-340-60 63187034060 60 TABLET, FILM COATED in 1 BOTTLE (63187-340-60) 2023-02-21 No No Current 63187-340-90 63187034090 90 TABLET, FILM COATED in 1 BOTTLE (63187-340-90) 2023-02-21 No No Current