OLANZAPINE

Product NDC
72303-0836
11-digit product format
723030836
Labeler code
72303
Product ID
72303-0836_4d2e9776-65f4-cb00-e063-6394a90a1bf7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Olanzapine
Dosage form
TABLET
Route
ORAL
Labeler
HEC Pharm USA Inc.
Application
ANDA206238
Marketing category
ANDA
Marketing start
2018-11-30
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
A206238-001OLANZAPINEOLANZAPINE2.5MGTABLET / ORALAB2018-11-19
A206238-002OLANZAPINEOLANZAPINE5MGTABLET / ORALAB2018-11-19
A206238-003OLANZAPINEOLANZAPINE7.5MGTABLET / ORALAB2018-11-19
A206238-004OLANZAPINEOLANZAPINE10MGTABLET / ORALAB2018-11-19
A206238-005OLANZAPINEOLANZAPINE15MGTABLET / ORALAB2018-11-19
A206238-006OLANZAPINEOLANZAPINE20MGTABLET / ORALAB2018-11-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A206238-001AB
A206238-002AB
A206238-003AB
A206238-004AB
A206238-005AB
A206238-006AB

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 UTC2026-02A206238-001OLANZAPINE2.5MGTABLET / ORAL2018-11-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206238-002OLANZAPINE5MGTABLET / ORAL2018-11-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206238-003OLANZAPINE7.5MGTABLET / ORAL2018-11-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206238-004OLANZAPINE10MGTABLET / ORAL2018-11-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206238-005OLANZAPINE15MGTABLET / ORAL2018-11-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206238-006OLANZAPINE20MGTABLET / ORAL2018-11-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206238-001OLANZAPINE2.5MGTABLET / ORAL2018-11-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206238-002OLANZAPINE5MGTABLET / ORAL2018-11-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206238-003OLANZAPINE7.5MGTABLET / ORAL2018-11-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206238-004OLANZAPINE10MGTABLET / ORAL2018-11-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206238-005OLANZAPINE15MGTABLET / ORAL2018-11-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206238-006OLANZAPINE20MGTABLET / ORAL2018-11-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A206238-001OLANZAPINE2.5MGTABLET / ORAL2018-11-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206238-002OLANZAPINE5MGTABLET / ORAL2018-11-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206238-003OLANZAPINE7.5MGTABLET / ORAL2018-11-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206238-004OLANZAPINE10MGTABLET / ORAL2018-11-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206238-005OLANZAPINE15MGTABLET / ORAL2018-11-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206238-006OLANZAPINE20MGTABLET / ORAL2018-11-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206238-001OLANZAPINE2.5MGTABLET / ORAL2018-11-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206238-002OLANZAPINE5MGTABLET / ORAL2018-11-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206238-003OLANZAPINE7.5MGTABLET / ORAL2018-11-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206238-004OLANZAPINE10MGTABLET / ORAL2018-11-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206238-005OLANZAPINE15MGTABLET / ORAL2018-11-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206238-006OLANZAPINE20MGTABLET / ORAL2018-11-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206238-001OLANZAPINE2.5MGTABLET / ORAL2018-11-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206238-002OLANZAPINE5MGTABLET / ORAL2018-11-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206238-003OLANZAPINE7.5MGTABLET / ORAL2018-11-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206238-004OLANZAPINE10MGTABLET / ORAL2018-11-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206238-005OLANZAPINE15MGTABLET / ORAL2018-11-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206238-006OLANZAPINE20MGTABLET / ORAL2018-11-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206238-001OLANZAPINE2.5MGTABLET / ORAL2018-11-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206238-002OLANZAPINE5MGTABLET / ORAL2018-11-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206238-003OLANZAPINE7.5MGTABLET / ORAL2018-11-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206238-004OLANZAPINE10MGTABLET / ORAL2018-11-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206238-005OLANZAPINE15MGTABLET / ORAL2018-11-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206238-006OLANZAPINE20MGTABLET / ORAL2018-11-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206238-001OLANZAPINE2.5MGTABLET / ORAL2018-11-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206238-002OLANZAPINE5MGTABLET / ORAL2018-11-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206238-003OLANZAPINE7.5MGTABLET / ORAL2018-11-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206238-004OLANZAPINE10MGTABLET / ORAL2018-11-192680178bc6a6…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A206238-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A206238-002AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A206238-003AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A206238-004AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A206238-005AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A206238-006AB1a50c72e98297…

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
4d34f8f3-edc8-0a68-e063-6394a90a9c1fAvailable 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
72303-0836-1OLANZAPINE30 in 1 BOTTLE, PLASTICTABLET301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72303-0836-1EA - Each72303-0836a03b8bae-2efa-446c-be01-d7cfb1d5417612026-05-22

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OLANZAPINEOLANZAPINEHEC Pharm USA Inc.4d34f8f3-edc8-0a68-e063-6394a90a9c1f2026-03-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206238
application number: ANDA206238
ndc (product): 72303-0836

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314154OLANZapine 10 MG Oral TabletPSN4d34f8f3-edc8-0a68-e063-6394a90a9c1f1
312077OLANZapine 15 MG Oral TabletPSN4d34f8f3-edc8-0a68-e063-6394a90a9c1f1
200034OLANZapine 2.5 MG Oral TabletPSN4d34f8f3-edc8-0a68-e063-6394a90a9c1f1
283639OLANZapine 20 MG Oral TabletPSN4d34f8f3-edc8-0a68-e063-6394a90a9c1f1
312078OLANZapine 5 MG Oral TabletPSN4d34f8f3-edc8-0a68-e063-6394a90a9c1f1
312079OLANZapine 7.5 MG Oral TabletPSN4d34f8f3-edc8-0a68-e063-6394a90a9c1f1
314154olanzapine 10 MG Oral TabletSCD4d34f8f3-edc8-0a68-e063-6394a90a9c1f1
312077olanzapine 15 MG Oral TabletSCD4d34f8f3-edc8-0a68-e063-6394a90a9c1f1
200034olanzapine 2.5 MG Oral TabletSCD4d34f8f3-edc8-0a68-e063-6394a90a9c1f1
283639olanzapine 20 MG Oral TabletSCD4d34f8f3-edc8-0a68-e063-6394a90a9c1f1
312078olanzapine 5 MG Oral TabletSCD4d34f8f3-edc8-0a68-e063-6394a90a9c1f1
312079olanzapine 7.5 MG Oral TabletSCD4d34f8f3-edc8-0a68-e063-6394a90a9c1f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72303-0836-17230308360130 TABLET in 1 BOTTLE, PLASTIC (72303-0836-1) 30 tablet2018-11-30NoNoCurrent