Olanzapine

Product NDC
60429-621
11-digit product format
604290621
Labeler code
60429
Product ID
60429-621_5023a1ed-b0d6-44d2-e063-6394a90ae2c3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Olanzapine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA090798
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 1.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090798-001OLANZAPINEOLANZAPINE2.5MGTABLET / ORALAB2012-04-23
A090798-002OLANZAPINEOLANZAPINE5MGTABLET / ORALAB2012-04-23
A090798-003OLANZAPINEOLANZAPINE7.5MGTABLET / ORALAB2012-04-23
A090798-004OLANZAPINEOLANZAPINE10MGTABLET / ORALAB2012-04-23
A090798-005OLANZAPINEOLANZAPINE15MGTABLET / ORALAB2012-04-23
A090798-006OLANZAPINEOLANZAPINE20MGTABLET / ORALAB2012-04-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-productTE code
A090798-001AB
A090798-002AB
A090798-003AB
A090798-004AB
A090798-005AB
A090798-006AB

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 · 246 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A090798-001OLANZAPINE2.5MGTABLET / ORALAB2012-04-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090798-002OLANZAPINE5MGTABLET / ORALAB2012-04-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090798-003OLANZAPINE7.5MGTABLET / ORALAB2012-04-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090798-004OLANZAPINE10MGTABLET / ORALAB2012-04-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090798-005OLANZAPINE15MGTABLET / ORALAB2012-04-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090798-006OLANZAPINE20MGTABLET / ORALAB2012-04-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090798-001OLANZAPINE2.5MGTABLET / ORALAB2012-04-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090798-002OLANZAPINE5MGTABLET / ORALAB2012-04-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090798-003OLANZAPINE7.5MGTABLET / ORALAB2012-04-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090798-004OLANZAPINE10MGTABLET / ORALAB2012-04-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090798-005OLANZAPINE15MGTABLET / ORALAB2012-04-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090798-006OLANZAPINE20MGTABLET / ORALAB2012-04-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A090798-001OLANZAPINE2.5MGTABLET / ORALAB2012-04-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090798-002OLANZAPINE5MGTABLET / ORALAB2012-04-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090798-003OLANZAPINE7.5MGTABLET / ORALAB2012-04-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090798-004OLANZAPINE10MGTABLET / ORALAB2012-04-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090798-005OLANZAPINE15MGTABLET / ORALAB2012-04-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090798-006OLANZAPINE20MGTABLET / ORALAB2012-04-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090798-001OLANZAPINE2.5MGTABLET / ORALAB2012-04-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090798-002OLANZAPINE5MGTABLET / ORALAB2012-04-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090798-003OLANZAPINE7.5MGTABLET / ORALAB2012-04-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090798-004OLANZAPINE10MGTABLET / ORALAB2012-04-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090798-005OLANZAPINE15MGTABLET / ORALAB2012-04-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090798-006OLANZAPINE20MGTABLET / ORALAB2012-04-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090798-001OLANZAPINE2.5MGTABLET / ORALAB2012-04-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090798-002OLANZAPINE5MGTABLET / ORALAB2012-04-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090798-003OLANZAPINE7.5MGTABLET / ORALAB2012-04-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090798-004OLANZAPINE10MGTABLET / ORALAB2012-04-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090798-005OLANZAPINE15MGTABLET / ORALAB2012-04-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090798-006OLANZAPINE20MGTABLET / ORALAB2012-04-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090798-001OLANZAPINE2.5MGTABLET / ORALAB2012-04-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090798-002OLANZAPINE5MGTABLET / ORALAB2012-04-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090798-003OLANZAPINE7.5MGTABLET / ORALAB2012-04-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090798-004OLANZAPINE10MGTABLET / ORALAB2012-04-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090798-005OLANZAPINE15MGTABLET / ORALAB2012-04-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090798-006OLANZAPINE20MGTABLET / ORALAB2012-04-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090798-001OLANZAPINE2.5MGTABLET / ORALAB2012-04-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090798-002OLANZAPINE5MGTABLET / ORALAB2012-04-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090798-003OLANZAPINE7.5MGTABLET / ORALAB2012-04-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090798-004OLANZAPINE10MGTABLET / ORALAB2012-04-232680178bc6a6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 246 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A090798-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090798-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090798-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090798-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090798-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090798-006AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090798-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090798-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090798-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090798-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090798-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090798-006AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090798-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090798-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090798-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090798-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090798-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090798-006AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090798-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090798-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090798-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090798-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090798-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090798-006AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090798-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090798-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090798-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090798-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090798-005AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090798-006AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090798-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090798-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090798-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090798-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090798-005AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090798-006AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090798-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090798-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090798-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090798-004AB12680178bc6a6…

Additional Listing Data#

Finished product
Yes
Brand name base
Olanzapine
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OLANZAPINE5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
N7U69T4SZRInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
200034Internal RxNorm lookup
283639Internal RxNorm lookup
312077Internal RxNorm lookup
312078Internal RxNorm lookup
312079Internal RxNorm lookup
314154Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a1dfb4e7-4143-4422-b7a7-292e4fd75044Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
42e9462d-db65-453b-8069-8fb2df9182e8Product name120211216
12d02c27-e8da-47f1-b815-ccca982731efProduct name920170802
877783eb-030c-6e3f-0979-804cf94d8856Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60429-621-01Olanzapine100 in 1 BOTTLETABLET, FILM COATED10012
60429-621-10Olanzapine1000 in 1 BOTTLETABLET, FILM COATED100012
60429-621-30Olanzapine30 in 1 BOTTLETABLET, FILM COATED3012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60429-621-01EA - Each60429-621efbdefdb-86b7-49ad-a7d3-ab5a9cad0c7e12025-05-14
60429-621-10EA - Each60429-621381199b3-f0eb-4c76-9343-eda87e37fcff12019-12-10
60429-621-30EA - Each60429-621262867eb-3dc5-47d2-be6b-43b7c513fcec12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OLANZAPINEACTIVE INGREDIENTN7U69T4SZROLANZAPINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]1
OLANZAPINEACTIVE MOIETYN7U69T4SZROLANZAPINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UOLANZAPINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKOLANZAPINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675OLANZAPINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTOLANZAPINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]1
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671POLANZAPINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]1
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6OLANZAPINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XOLANZAPINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30OLANZAPINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AOLANZAPINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJOLANZAPINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPOLANZAPINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60429-621OLANZAPINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]11Current NDC, Legacy NDC, 3 package rows20250426_a1dfb4e7-4143-4422-b7a7-292e4fd75044.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 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OlanzapineOLANZAPINEREMEDYREPACK INC.e830f488-c689-40f6-9351-f9c7454ff1ea2026-06-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090798
application number: ANDA090798
OlanzapineOLANZAPINEREMEDYREPACK INC.032e589c-47b1-4eb1-9466-8160297b81e92026-06-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090798
application number: ANDA090798
OlanzapineOLANZAPINEGolden State Medical Supply, Inc.a1dfb4e7-4143-4422-b7a7-292e4fd750442026-04-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090798
application number: ANDA090798
ndc (product): 60429-621
OlanzapineOLANZAPINEApotex Corp.3347d1c8-04c9-5ce1-8cda-b38e0412b7092025-11-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090798
application number: ANDA090798
OlanzapineOLANZAPINEBryant Ranch Prepack1866a03c-eac9-44a1-8f33-7dc6e8a8c06a2025-06-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090798
application number: ANDA090798
OlanzapineOLANZAPINEProficient Rx LP024e8e9b-a4fc-4882-b080-c070467166a62024-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090798
application number: ANDA090798
OlanzapineOLANZAPINEProficient Rx LPe40d54bf-7334-4418-8a87-ff85941adec12021-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090798
application number: ANDA090798
OlanzapineOLANZAPINEAphena Pharma Solutions - Tennessee, LLCb6ec5610-b4a6-4646-954a-0fe8b1d3e1432020-05-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090798
application number: ANDA090798
OlanzapineOLANZAPINEProficient Rx LP7772a4c2-1fb1-412b-9e3b-ef3d693517a22019-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090798
application number: ANDA090798

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314154OLANZapine 10 MG Oral TabletPSNa1dfb4e7-4143-4422-b7a7-292e4fd7504412
312077OLANZapine 15 MG Oral TabletPSNa1dfb4e7-4143-4422-b7a7-292e4fd7504412
200034OLANZapine 2.5 MG Oral TabletPSNa1dfb4e7-4143-4422-b7a7-292e4fd7504412
283639OLANZapine 20 MG Oral TabletPSNa1dfb4e7-4143-4422-b7a7-292e4fd7504412
312078OLANZapine 5 MG Oral TabletPSNa1dfb4e7-4143-4422-b7a7-292e4fd7504412
312079OLANZapine 7.5 MG Oral TabletPSNa1dfb4e7-4143-4422-b7a7-292e4fd7504412
314154olanzapine 10 MG Oral TabletSCDa1dfb4e7-4143-4422-b7a7-292e4fd7504412
312077olanzapine 15 MG Oral TabletSCDa1dfb4e7-4143-4422-b7a7-292e4fd7504412
200034olanzapine 2.5 MG Oral TabletSCDa1dfb4e7-4143-4422-b7a7-292e4fd7504412
283639olanzapine 20 MG Oral TabletSCDa1dfb4e7-4143-4422-b7a7-292e4fd7504412
312078olanzapine 5 MG Oral TabletSCDa1dfb4e7-4143-4422-b7a7-292e4fd7504412
312079olanzapine 7.5 MG Oral TabletSCDa1dfb4e7-4143-4422-b7a7-292e4fd7504412

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60429-621-0160429062101100 TABLET, FILM COATED in 1 BOTTLE (60429-621-01) 2025-04-23NoNoCurrent
60429-621-10604290621101000 TABLET, FILM COATED in 1 BOTTLE (60429-621-10) 2019-10-160000-00-00NoNoCurrent
60429-621-306042906213030 TABLET, FILM COATED in 1 BOTTLE (60429-621-30) 2019-10-160000-00-00NoNoCurrent