FDA.reportPublic FDA data

Ondansetron

Product NDC
85766-213
Requested package NDC
85766-213-10
11-digit product format
857660213
Labeler code
85766
Product ID
85766-213_5586bc5f-b812-e6fa-e063-6394a90ac1a2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ondansetron
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Sportpharm LLC
Application
ANDA090469
Marketing category
ANDA
Marketing start
2010-04-12
Substance
ONDANSETRON
Active strength
4 mg/1
Pharmacologic classes
Serotonin 3 Receptor Antagonists [MoA]; Serotonin-3 Receptor Antagonist [EPC]
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090469-001ONDANSETRONONDANSETRON4MGTABLET, ORALLY DISINTEGRATING / ORALAB2010-04-12
A090469-002ONDANSETRONONDANSETRON8MGTABLET, ORALLY DISINTEGRATING / ORALABRS2010-04-12

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A090469-001AB
A090469-002AB

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A090469-001ONDANSETRON4MGTABLET, ORALLY DISINTEGRATING / ORALAB2010-04-12a50c72e98297…
2026-08-01 22:54:322026-06A090469-002ONDANSETRON8MGTABLET, ORALLY DISINTEGRATING / ORALABRS2010-04-12a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A090469-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A090469-002AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 3 · 45 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OndansetronONDANSETRONHAWAII REPACK, INC.b76c5cc9-f1ca-428b-8989-36a66802b6502026-07-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090469
application number: ANDA090469
OndansetronONDANSETRONREMEDYREPACK INC.18063a64-a4c0-4bad-911b-00df5c7bb65d2026-07-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090469
application number: ANDA090469
OndansetronONDANSETRONBryant Ranch Prepack77397df5-5a4f-41b2-98bc-f817a1e497fc2026-07-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090469
application number: ANDA090469
OndansetronONDANSETRONSportpharm LLC822404ad-af08-4c62-ae38-7d9819e860792026-07-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090469
application number: ANDA090469
ndc (package): 85766-213-10
ndc (product): 85766-213
ndc11 (package): 85766021310
OndansetronONDANSETRONSt. Mary's Medical Park Pharmacy3207cf04-73b7-24ce-e054-00144ff8d46c2026-06-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090469
application number: ANDA090469
ONDANSETRONONDANSETRONDirect Rxb38feff2-900a-4e0c-8260-8f090edbc0bc2026-03-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090469
application number: ANDA090469
OndansetronONDANSETRONA-S Medication Solutions378d0963-d026-4478-8202-fbb636904a372026-02-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090469
application number: ANDA090469
OndansetronONDANSETRONSportpharm LLC3c4cda2f-13d9-42c5-b449-77deb06c8de52026-02-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090469
application number: ANDA090469
OndansetronONDANSETRONNuCare Pharmaceuticals,Inc.9dff6676-e69e-779d-e053-2995a90a7c812026-01-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090469
application number: ANDA090469
OndansetronONDANSETRONNuCare Pharmaceuticals,Inc.76666e7e-3312-6f9d-e053-2991aa0af7052026-01-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090469
application number: ANDA090469
OndansetronONDANSETRONNorthwind Health Company, LLCf2b502e2-03ed-fe5c-e053-2995a90a368e2026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090469
application number: ANDA090469
OndansetronONDANSETRONNorthwind Health Company, LLCdb9a0d22-9339-4319-e053-2a95a90a95922026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090469
application number: ANDA090469
OndansetronONDANSETRONNorthwind Health Company, LLCe07c38c0-e1c2-01de-e053-2995a90a390a2026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090469
application number: ANDA090469
OndansetronONDANSETRONPD-Rx Pharmaceuticals, Inc.9558d296-8edd-4aa1-875a-6247f9a8374d2025-09-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090469
application number: ANDA090469
OndansetronONDANSETRONPD-Rx Pharmaceuticals, Inc.10afd68b-877f-4819-a314-39f2d56d5db92025-09-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090469
application number: ANDA090469
OndansetronONDANSETRONPreferred Pharmaceuticals, Inc.b9abd5ce-6aca-4fda-8f46-0bb5b7fdd5da2025-09-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090469
application number: ANDA090469
OndansetronONDANSETRONPreferred Pharmaceuticals, Inc.66ac9c17-bea7-4f8d-8a27-a1e0f9e659452025-09-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090469
application number: ANDA090469
OndansetronONDANSETRONPreferred Pharmaceuticals, Inc.70b48280-ef74-472b-abc3-128962bfcb052025-09-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090469
application number: ANDA090469
OndansetronONDANSETRONCardinal Health 107, LLCb50c1767-8a50-49ab-be31-6533021ae7c42025-08-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090469
application number: ANDA090469
OndansetronONDANSETRONRising Pharma Holdings, Inc.eb74425c-c635-4d99-8e98-e63e7359fb892025-07-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090469
application number: ANDA090469

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ONDANSETRON4 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4AF302ESOSInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
104894Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
822404ad-af08-4c62-ae38-7d9819e86079Available on FDA.report

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleStatus
85766-213-10857660213101 BLISTER PACK in 1 CARTON (85766-213-10) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK1 blister pack2026-07-010Current