ondansetron hydrochloride
- Product NDC
- 62756-131
- 11-digit product format
- 627560131
- Labeler code
- 62756
- Product ID
- 62756-131_e83d90db-54a7-4c13-bd68-b1620a8aecaf
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ondansetron hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- ANDA077050
- Marketing category
- ANDA
- Marketing start
- 2007-06-25
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- ondansetron hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ONDANSETRON HYDROCHLORIDE | 8 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 4AF302ESOS, NMH84OZK2B |
| Rxcui | 104894, 198052, 312086, 312087 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| d9bd4853-037c-6968-f4d4-9bb9a0efd1ea | Product name | 2 | 20250722 |
| 32e23bc9-ce14-4555-bb6d-bcb654d7d296 | Product name | 1 | 20201015 |
| e459f50a-1553-4aab-b6bd-1e5f0c211c49 | Product name | 1 | 20201015 |
| 909480fe-0d18-c1c1-a658-0bd9a7131822 | Product name | 5 | 20170829 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 62756-131-01 | ondansetron hydrochloride | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | 18 | |
| 62756-131-02 | ondansetron hydrochloride | 10 in 1 BLISTER PACK | TABLET, FILM COATED | 10 | 18 | |
| 62756-131-02 | ondansetron hydrochloride | 10 in 1 DOSE PACK | TABLET, FILM COATED | 10 | 18 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 62756-131-01 | EA - Each | 62756-131 | de4c1230-52a7-4f64-ac0d-9cdef71df0a3 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 62756-131 | ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED ONDANSETRON TABLET, ORALLY DISINTEGRATING [SUN PHARMACEUTICAL INDUSTRIES, INC.] | 17 | Current NDC, Legacy NDC, 3 package rows | 20250419_92c758a3-e749-4a15-be4b-ee30b364b2b0.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 104894 | ondansetron 4 MG Disintegrating Oral Tablet | PSN | 92c758a3-e749-4a15-be4b-ee30b364b2b0 | 18 |
| 312087 | ondansetron 8 MG Disintegrating Oral Tablet | PSN | 92c758a3-e749-4a15-be4b-ee30b364b2b0 | 18 |
| 198052 | ondansetron HCl 4 MG Oral Tablet | PSN | 92c758a3-e749-4a15-be4b-ee30b364b2b0 | 18 |
| 312086 | ondansetron HCl 8 MG Oral Tablet | PSN | 92c758a3-e749-4a15-be4b-ee30b364b2b0 | 18 |
| 104894 | ondansetron 4 MG Disintegrating Oral Tablet | SCD | 92c758a3-e749-4a15-be4b-ee30b364b2b0 | 18 |
| 198052 | ondansetron 4 MG Oral Tablet | SCD | 92c758a3-e749-4a15-be4b-ee30b364b2b0 | 18 |
| 312087 | ondansetron 8 MG Disintegrating Oral Tablet | SCD | 92c758a3-e749-4a15-be4b-ee30b364b2b0 | 18 |
| 312086 | ondansetron 8 MG Oral Tablet | SCD | 92c758a3-e749-4a15-be4b-ee30b364b2b0 | 18 |
| 198052 | ondansetron 4 MG (as ondansetron HCl dihydrate 5 MG) Oral Tablet | SY | 92c758a3-e749-4a15-be4b-ee30b364b2b0 | 18 |
| 312086 | ondansetron 8 MG (as ondansetron HCl dihydrate 10 MG) Oral Tablet | SY | 92c758a3-e749-4a15-be4b-ee30b364b2b0 | 18 |
| 198052 | ondansetron HCl 4 MG Oral Tablet | PSN | 69b9a032-f2d1-4c5a-a35e-9cdc3c620716 | 5 |
| 312086 | ondansetron HCl 8 MG Oral Tablet | PSN | 69b9a032-f2d1-4c5a-a35e-9cdc3c620716 | 5 |
| 198052 | ondansetron 4 MG Oral Tablet | SCD | 69b9a032-f2d1-4c5a-a35e-9cdc3c620716 | 5 |
| 312086 | ondansetron 8 MG Oral Tablet | SCD | 69b9a032-f2d1-4c5a-a35e-9cdc3c620716 | 5 |
| 198052 | ondansetron 4 MG (as ondansetron HCl dihydrate 5 MG) Oral Tablet | SY | 69b9a032-f2d1-4c5a-a35e-9cdc3c620716 | 5 |
| 312086 | ondansetron 8 MG (as ondansetron HCl dihydrate 10 MG) Oral Tablet | SY | 69b9a032-f2d1-4c5a-a35e-9cdc3c620716 | 5 |
| 312086 | ondansetron HCl 8 MG Oral Tablet | PSN | bf47aac9-ffb5-4e06-a3de-7caf50cbec77 | 4 |
| 312086 | ondansetron 8 MG Oral Tablet | SCD | bf47aac9-ffb5-4e06-a3de-7caf50cbec77 | 4 |
| 312086 | ondansetron 8 MG (as ondansetron HCl dihydrate 10 MG) Oral Tablet | SY | bf47aac9-ffb5-4e06-a3de-7caf50cbec77 | 4 |
| 198052 | ondansetron HCl 4 MG Oral Tablet | PSN | 2e57105a-b925-4182-9f70-d0fa0e613051 | 2 |
| 312086 | ondansetron HCl 8 MG Oral Tablet | PSN | 2e57105a-b925-4182-9f70-d0fa0e613051 | 2 |
| 198052 | ondansetron 4 MG Oral Tablet | SCD | 2e57105a-b925-4182-9f70-d0fa0e613051 | 2 |
| 312086 | ondansetron 8 MG Oral Tablet | SCD | 2e57105a-b925-4182-9f70-d0fa0e613051 | 2 |
| 198052 | ondansetron 4 MG (as ondansetron HCl dihydrate 5 MG) Oral Tablet | SY | 2e57105a-b925-4182-9f70-d0fa0e613051 | 2 |
| 312086 | ondansetron 8 MG (as ondansetron HCl dihydrate 10 MG) Oral Tablet | SY | 2e57105a-b925-4182-9f70-d0fa0e613051 | 2 |
| 198052 | ondansetron HCl 4 MG Oral Tablet | PSN | c5378585-dd35-4123-82b9-91395b56c3eb | 1 |
| 312086 | ondansetron HCl 8 MG Oral Tablet | PSN | c5378585-dd35-4123-82b9-91395b56c3eb | 1 |
| 198052 | ondansetron 4 MG Oral Tablet | SCD | c5378585-dd35-4123-82b9-91395b56c3eb | 1 |
| 312086 | ondansetron 8 MG Oral Tablet | SCD | c5378585-dd35-4123-82b9-91395b56c3eb | 1 |
| 198052 | ondansetron 4 MG (as ondansetron HCl dihydrate 5 MG) Oral Tablet | SY | c5378585-dd35-4123-82b9-91395b56c3eb | 1 |
| 312086 | ondansetron 8 MG (as ondansetron HCl dihydrate 10 MG) Oral Tablet | SY | c5378585-dd35-4123-82b9-91395b56c3eb | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 62756-131-01 | 62756013101 | 30 TABLET, FILM COATED in 1 BOTTLE (62756-131-01) | 2007-06-25 | 0000-00-00 | No | No | Current | |
| 62756-131-02 | 62756013102 | 10 BLISTER PACK in 1 DOSE PACK (62756-131-02) / 10 TABLET, FILM COATED in 1 BLISTER PACK | 10 blister pack | 2007-06-25 | 0000-00-00 | No | No | Current |