FDA.reportPublic FDA data

Ondansetron

Product NDC
70518-4685
Requested package NDC
70518-4685-0
11-digit product format
705184685
Labeler code
70518
Product ID
70518-4685_560986a0-e4eb-5c4c-e063-6394a90aa552
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ondansetron
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA078152
Marketing category
ANDA
Marketing start
2026-06-29
Substance
ONDANSETRON
Active strength
8 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
A078152-001ONDANSETRONONDANSETRON4MGTABLET, ORALLY DISINTEGRATING / ORALAB2007-06-27
A078152-002ONDANSETRONONDANSETRON8MGTABLET, ORALLY DISINTEGRATING / ORALAB2007-06-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A078152-001AB
A078152-002AB

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 22:54:322026-06A078152-001ONDANSETRON4MGTABLET, ORALLY DISINTEGRATING / ORALAB2007-06-27a50c72e98297…
2026-08-01 22:54:322026-06A078152-002ONDANSETRON8MGTABLET, ORALLY DISINTEGRATING / ORALAB2007-06-27a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A078152-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A078152-002AB1a50c72e98297…

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 2 · 25 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OndansetronONDANSETRONA-S Medication Solutions5a81a39b-051b-414e-a6b0-d844de4e9ab42026-07-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078152
application number: ANDA078152
OndansetronONDANSETRONA-S Medication Solutions02ddd5f5-76d3-4f1c-9af3-d39e05a19c292026-07-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078152
application number: ANDA078152
OndansetronONDANSETRONREMEDYREPACK INC.9c3ad9c1-474e-4331-a017-09cec46702d82026-07-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078152
application number: ANDA078152
ndc (package): 70518-4685-0
ndc (product): 70518-4685
ndc11 (package): 70518468500
OndansetronONDANSETRONNuCare Pharmaceuticals,Inc4575d288-be0c-f6c3-e063-6294a90af7082026-06-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078152
application number: ANDA078152
OndansetronONDANSETRONCardinal Health 107, LLC3c34ca82-9705-4784-be7c-8b50351d14fc2026-06-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078152
application number: ANDA078152
OndansetronONDANSETRONPreferred Pharmaceuticals Inc.e87a5803-e872-43f7-8a15-79aa236e8c072026-06-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078152
application number: ANDA078152
OndansetronONDANSETRONBluePoint Laboratoriesed1132ec-c2cd-4646-b69d-26663bb937a42026-06-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078152
application number: ANDA078152
OndansetronONDANSETRONREMEDYREPACK INC.c0d827d0-333f-4187-ac75-9dc7d34b61692026-05-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078152
application number: ANDA078152
OndansetronONDANSETRONNuCare Pharmaceuticals,Inc.5bacb621-1261-25d9-e053-2991aa0afa3b2026-04-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078152
application number: ANDA078152
OndansetronONDANSETRONNuCare Pharmaceuticals,Inc.df736abd-9cec-4e90-e053-2995a90aab5e2026-03-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078152
application number: ANDA078152
OndansetronONDANSETRONNuCare Pharmaceuticals, Inc.50383ef5-6e6e-63a7-e054-00144ff88e882026-03-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078152
application number: ANDA078152
OndansetronONDANSETRONNuCare Pharmaceuticals,Inc.ef6ce203-4ae3-19c9-e053-2995a90af7962026-02-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078152
application number: ANDA078152
OndansetronONDANSETRONST. MARY'S MEDICAL PARK PHARMACY41366a20-0727-0446-e063-6294a90a957f2026-02-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078152
application number: ANDA078152
OndansetronONDANSETRONPD-Rx Pharmaceuticals, Inc.d117de5f-64e5-464c-b782-de0f07e66c8e2026-01-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078152
application number: ANDA078152
OndansetronONDANSETRONGlenmark Pharmaceuticals Inc., USAeee5217a-eba8-463a-812d-bf3c66f0934f2026-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078152
application number: ANDA078152
OndansetronONDANSETRONNorthwind Health Company, LLCf29f5cfa-3cc4-7d53-e053-2995a90ae8442025-12-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078152
application number: ANDA078152
OndansetronONDANSETRONST. MARY'S MEDICAL PARK PHARMACYf175a336-433b-7ab2-e053-2995a90ad5ca2025-12-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078152
application number: ANDA078152
OndansetronONDANSETRONAvKARE352de988-d166-c2d8-e063-6294a90acc012025-11-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078152
application number: ANDA078152
OndansetronONDANSETRONProficient Rx LP81366c85-c6c9-4a9a-9fe5-cdd8c2d19f742025-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078152
application number: ANDA078152
OndansetronONDANSETRONPreferred Pharmaceuticals Inc.7975d78c-9bb6-467a-9c2d-ea15bde7af5c2025-09-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078152
application number: ANDA078152

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ONDANSETRON8 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
312087Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
9c3ad9c1-474e-4331-a017-09cec46702d8Available on FDA.report

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleStatus
70518-4685-0705184685006 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (70518-4685-0)2026-06-290Current