Home NDC 65862-562-10 Olanzapine
Product NDC 65862-562
Requested package NDC 65862-562-10
11-digit product format 658620562
Labeler code 65862
Product ID 65862-562_e10b90de-4a0a-413e-a5f9-6978a183b568
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Olanzapine
Dosage form TABLET
Route ORAL
Labeler Aurobindo Pharma Limited
Application ANDA202050
Marketing category ANDA
Marketing start 2012-04-23
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 A202050-001 OLANZAPINE OLANZAPINE 2.5MG TABLET / ORAL AB 2012-04-23 A202050-002 OLANZAPINE OLANZAPINE 5MG TABLET / ORAL AB 2012-04-23 A202050-003 OLANZAPINE OLANZAPINE 7.5MG TABLET / ORAL AB 2012-04-23 A202050-004 OLANZAPINE OLANZAPINE 10MG TABLET / ORAL AB 2012-04-23 A202050-005 OLANZAPINE OLANZAPINE 15MG TABLET / ORAL AB 2012-04-23 A202050-006 OLANZAPINE OLANZAPINE 20MG TABLET / ORAL AB 2012-04-23
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 A202050-001 OLANZAPINE 2.5MG TABLET / ORAL AB 2012-04-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 A202050-002 OLANZAPINE 5MG TABLET / ORAL AB 2012-04-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 A202050-003 OLANZAPINE 7.5MG TABLET / ORAL AB 2012-04-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 A202050-004 OLANZAPINE 10MG TABLET / ORAL AB 2012-04-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 A202050-005 OLANZAPINE 15MG TABLET / ORAL AB 2012-04-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 A202050-006 OLANZAPINE 20MG TABLET / ORAL AB 2012-04-23 84e616aacf4f…2026-08-18 06:07:40 2026-07 A202050-001 OLANZAPINE 2.5MG TABLET / ORAL AB 2012-04-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202050-002 OLANZAPINE 5MG TABLET / ORAL AB 2012-04-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202050-003 OLANZAPINE 7.5MG TABLET / ORAL AB 2012-04-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202050-004 OLANZAPINE 10MG TABLET / ORAL AB 2012-04-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202050-005 OLANZAPINE 15MG TABLET / ORAL AB 2012-04-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202050-006 OLANZAPINE 20MG TABLET / ORAL AB 2012-04-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A202050-001 OLANZAPINE 2.5MG TABLET / ORAL AB 2012-04-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202050-002 OLANZAPINE 5MG TABLET / ORAL AB 2012-04-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202050-003 OLANZAPINE 7.5MG TABLET / ORAL AB 2012-04-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202050-004 OLANZAPINE 10MG TABLET / ORAL AB 2012-04-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202050-005 OLANZAPINE 15MG TABLET / ORAL AB 2012-04-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202050-006 OLANZAPINE 20MG TABLET / ORAL AB 2012-04-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202050-001 OLANZAPINE 2.5MG TABLET / ORAL AB 2012-04-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202050-002 OLANZAPINE 5MG TABLET / ORAL AB 2012-04-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202050-003 OLANZAPINE 7.5MG TABLET / ORAL AB 2012-04-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202050-004 OLANZAPINE 10MG TABLET / ORAL AB 2012-04-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202050-005 OLANZAPINE 15MG TABLET / ORAL AB 2012-04-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202050-006 OLANZAPINE 20MG TABLET / ORAL AB 2012-04-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202050-001 OLANZAPINE 2.5MG TABLET / ORAL AB 2012-04-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202050-002 OLANZAPINE 5MG TABLET / ORAL AB 2012-04-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202050-003 OLANZAPINE 7.5MG TABLET / ORAL AB 2012-04-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202050-004 OLANZAPINE 10MG TABLET / ORAL AB 2012-04-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202050-005 OLANZAPINE 15MG TABLET / ORAL AB 2012-04-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202050-006 OLANZAPINE 20MG TABLET / ORAL AB 2012-04-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202050-001 OLANZAPINE 2.5MG TABLET / ORAL AB 2012-04-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202050-002 OLANZAPINE 5MG TABLET / ORAL AB 2012-04-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202050-003 OLANZAPINE 7.5MG TABLET / ORAL AB 2012-04-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202050-004 OLANZAPINE 10MG TABLET / ORAL AB 2012-04-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202050-005 OLANZAPINE 15MG TABLET / ORAL AB 2012-04-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202050-006 OLANZAPINE 20MG TABLET / ORAL AB 2012-04-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202050-001 OLANZAPINE 2.5MG TABLET / ORAL AB 2012-04-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202050-002 OLANZAPINE 5MG TABLET / ORAL AB 2012-04-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202050-003 OLANZAPINE 7.5MG TABLET / ORAL AB 2012-04-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202050-004 OLANZAPINE 10MG TABLET / ORAL AB 2012-04-23 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 · 6 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 200034 Internal RxNorm lookup 283639 Internal RxNorm lookup 312077 Internal RxNorm lookup 312078 Internal RxNorm lookup 312079 Internal RxNorm lookup 314154 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65862-562 OLANZAPINE TABLET [AUROBINDO PHARMA LIMITED] 20 Current NDC, Legacy NDC, 5 package rows 20250306_636665be-9d7e-443a-8134-e8cc47e6ba24.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 · 2 matching rows.
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 65862-562-10 65862056210 10 BLISTER PACK in 1 CARTON (65862-562-10) / 10 TABLET in 1 BLISTER PACK 10 blister pack 2012-04-23 0000-00-00 No No Current