Home NDC 51672-4109-8 Ondansetron Hydrochloride
Product NDC 51672-4109
Requested package NDC 51672-4109-8
11-digit product format 516724109
Labeler code 51672
Product ID 51672-4109_288442cd-0f6b-49e1-9acc-d8f613f54810
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ondansetron Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Taro Pharmaceuticals U.S.A., Inc.
Application ANDA077729
Marketing category ANDA
Marketing start 2011-03-28
Marketing end 0000-00-00
Substance ONDANSETRON HYDROCHLORIDE
Active strength 8 mg/1
Pharmacologic classes Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]
NDC exclude flag No
Listing certified through 2020-12-31
Current FDA listing Historical FDA.report record Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A077729-001 ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL 2011-03-28 A077729-002 ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE EQ 8MG BASE TABLET / ORAL 2011-03-28 A077729-003 ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE EQ 24MG BASE TABLET / ORAL 2011-03-28
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 4 · 132 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 2026-10-15 13:18:30 2026-09 A077729-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL 2011-03-28 c2088c7a36db…2026-10-15 13:18:30 2026-09 A077729-002 ONDANSETRON HYDROCHLORIDE EQ 8MG BASE TABLET / ORAL 2011-03-28 c2088c7a36db…2026-10-15 13:18:30 2026-09 A077729-003 ONDANSETRON HYDROCHLORIDE EQ 24MG BASE TABLET / ORAL 2011-03-28 c2088c7a36db…2026-09-14 22:38:34 2026-08 A077729-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL 2011-03-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077729-002 ONDANSETRON HYDROCHLORIDE EQ 8MG BASE TABLET / ORAL 2011-03-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077729-003 ONDANSETRON HYDROCHLORIDE EQ 24MG BASE TABLET / ORAL 2011-03-28 84e616aacf4f…2026-08-18 06:07:40 2026-07 A077729-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL 2011-03-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077729-002 ONDANSETRON HYDROCHLORIDE EQ 8MG BASE TABLET / ORAL 2011-03-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077729-003 ONDANSETRON HYDROCHLORIDE EQ 24MG BASE TABLET / ORAL 2011-03-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077729-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL 2011-03-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077729-002 ONDANSETRON HYDROCHLORIDE EQ 8MG BASE TABLET / ORAL 2011-03-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077729-003 ONDANSETRON HYDROCHLORIDE EQ 24MG BASE TABLET / ORAL 2011-03-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077729-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL 2011-03-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077729-002 ONDANSETRON HYDROCHLORIDE EQ 8MG BASE TABLET / ORAL 2011-03-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077729-003 ONDANSETRON HYDROCHLORIDE EQ 24MG BASE TABLET / ORAL 2011-03-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077729-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL 2011-03-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077729-002 ONDANSETRON HYDROCHLORIDE EQ 8MG BASE TABLET / ORAL 2011-03-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077729-003 ONDANSETRON HYDROCHLORIDE EQ 24MG BASE TABLET / ORAL 2011-03-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077729-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL 2011-03-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077729-002 ONDANSETRON HYDROCHLORIDE EQ 8MG BASE TABLET / ORAL 2011-03-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077729-003 ONDANSETRON HYDROCHLORIDE EQ 24MG BASE TABLET / ORAL 2011-03-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077729-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL 2011-03-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077729-002 ONDANSETRON HYDROCHLORIDE EQ 8MG BASE TABLET / ORAL 2011-03-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077729-003 ONDANSETRON HYDROCHLORIDE EQ 24MG BASE TABLET / ORAL 2011-03-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077729-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL 2011-03-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077729-002 ONDANSETRON HYDROCHLORIDE EQ 8MG BASE TABLET / ORAL 2011-03-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077729-003 ONDANSETRON HYDROCHLORIDE EQ 24MG BASE TABLET / ORAL 2011-03-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077729-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL 2011-03-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077729-002 ONDANSETRON HYDROCHLORIDE EQ 8MG BASE TABLET / ORAL 2011-03-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077729-003 ONDANSETRON HYDROCHLORIDE EQ 24MG BASE TABLET / ORAL 2011-03-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077729-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL 2011-03-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077729-002 ONDANSETRON HYDROCHLORIDE EQ 8MG BASE TABLET / ORAL 2011-03-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077729-003 ONDANSETRON HYDROCHLORIDE EQ 24MG BASE TABLET / ORAL 2011-03-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077729-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL 2011-03-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077729-002 ONDANSETRON HYDROCHLORIDE EQ 8MG BASE TABLET / ORAL 2011-03-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077729-003 ONDANSETRON HYDROCHLORIDE EQ 24MG BASE TABLET / ORAL 2011-03-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077729-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL 2011-03-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077729-002 ONDANSETRON HYDROCHLORIDE EQ 8MG BASE TABLET / ORAL 2011-03-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077729-003 ONDANSETRON HYDROCHLORIDE EQ 24MG BASE TABLET / ORAL 2011-03-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077729-001 ONDANSETRON HYDROCHLORIDE EQ 4MG BASE TABLET / ORAL 2011-03-28 79d66fd596c7…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Ondansetron Hydrochloride ACTIVE INGREDIENT NMH84OZK2B ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [TARO PHARMACEUTICALS U.S.A., INC.] 4 Ondansetron ACTIVE MOIETY 4AF302ESOS ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [TARO PHARMACEUTICALS U.S.A., INC.] 4 aluminum oxide INACTIVE INGREDIENT LMI26O6933 ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [TARO PHARMACEUTICALS U.S.A., INC.] 4 cellulose, microcrystalline INACTIVE INGREDIENT OP1R32D61U ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [TARO PHARMACEUTICALS U.S.A., INC.] 4 FD&C blue no. 2 INACTIVE INGREDIENT L06K8R7DQK ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [TARO PHARMACEUTICALS U.S.A., INC.] 4 ferric oxide red INACTIVE INGREDIENT 1K09F3G675 ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [TARO PHARMACEUTICALS U.S.A., INC.] 4 ferric oxide yellow INACTIVE INGREDIENT EX438O2MRT ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [TARO PHARMACEUTICALS U.S.A., INC.] 4 lactose INACTIVE INGREDIENT J2B2A4N98G ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [TARO PHARMACEUTICALS U.S.A., INC.] 4 magnesium stearate INACTIVE INGREDIENT 70097M6I30 ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [TARO PHARMACEUTICALS U.S.A., INC.] 4 polyethylene glycols INACTIVE INGREDIENT 3WJQ0SDW1A ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [TARO PHARMACEUTICALS U.S.A., INC.] 4 polyvinyl alcohol INACTIVE INGREDIENT 532B59J990 ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [TARO PHARMACEUTICALS U.S.A., INC.] 4 starch, corn INACTIVE INGREDIENT O8232NY3SJ ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [TARO PHARMACEUTICALS U.S.A., INC.] 4 talc INACTIVE INGREDIENT 7SEV7J4R1U ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [TARO PHARMACEUTICALS U.S.A., INC.] 4 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [TARO PHARMACEUTICALS U.S.A., INC.] 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51672-4109 ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [TARO PHARMACEUTICALS U.S.A., INC.] 5 Legacy NDC 20180223_29cda698-cfd4-43e1-b69e-884d08d8918a.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 51672-4109-8 51672410908 1 BLISTER PACK in 1 CARTON (51672-4109-8) > 3 TABLET, FILM COATED in 1 BLISTER PACK 1 blister pack 2011-03-28 0000-00-00 No No Current