Home NDC 66993-681-30 OLANZAPINE
Product NDC 66993-681
Requested package NDC 66993-681-30
11-digit product format 669930681
Labeler code 66993
Product ID 66993-681_257af069-b3dd-4a9f-938e-fcff35e4c9cd
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name olanzapine
Dosage form TABLET
Route ORAL
Labeler Prasco Laboratories
Application ANDA202050
Marketing category ANDA
Marketing start 2012-04-23
Marketing end 0000-00-00
Substance OLANZAPINE
Active strength 5 mg/1
Pharmacologic classes Atypical Antipsychotic [EPC]
NDC exclude flag No
Listing certified through 2022-12-31
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 · 9 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…
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.
DailyMed Socrata Ingredients# 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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 66993-681-30 66993068130 30 TABLET in 1 BOTTLE (66993-681-30) 30 tablet 2012-04-23 0000-00-00 No No Current