ondansetron
- Product NDC
- 62756-356
- 11-digit product format
- 627560356
- Labeler code
- 62756
- Product ID
- 62756-356_e83d90db-54a7-4c13-bd68-b1620a8aecaf
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ondansetron
- Dosage form
- TABLET, ORALLY DISINTEGRATING
- Route
- ORAL
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- ANDA077557
- Marketing category
- ANDA
- Marketing start
- 2007-08-02
- Substance
- ONDANSETRON
- 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
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ONDANSETRON | 8 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | NMH84OZK2B, 4AF302ESOS |
| Rxcui | 104894, 198052, 312086, 312087 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| d9bd4853-037c-6968-f4d4-9bb9a0efd1ea | Product name | 2 | 20250722 |
| a62a50ac-1535-4461-9768-8ae703e2e9fb | Product name | 1 | 20210525 |
| 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 |
| 9514609b-a2a9-f8ec-6ba6-3f8e5ee89877 | Product name | 1 | 20140508 |
| bc07ef78-e82d-0c19-31f4-31f263780582 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 62756-356-64 | ondansetron | 3 in 1 DOSE PACK | TABLET, ORALLY DISINTEGRATING | 3 | 18 | |
| 62756-356-64 | ondansetron | 10 in 1 BLISTER PACK | TABLET, ORALLY DISINTEGRATING | 10 | 18 | |
| 62756-356-66 | ondansetron | 1 in 1 DOSE PACK | TABLET, ORALLY DISINTEGRATING | 1 | 18 | |
| 62756-356-66 | ondansetron | 10 in 1 BLISTER PACK | TABLET, ORALLY DISINTEGRATING | 10 | 18 | |
| 62756-356-83 | ondansetron | 30 in 1 BOTTLE | TABLET, ORALLY DISINTEGRATING | 30 | 18 | |
| 62756-356-64 | ONDANSETRON | 3 in 1 DOSE PACK | TABLET, ORALLY DISINTEGRATING | 3 | 5 | |
| 62756-356-64 | ONDANSETRON | 10 in 1 BLISTER PACK | TABLET, ORALLY DISINTEGRATING | 10 | 5 | |
| 62756-356-66 | ONDANSETRON | 1 in 1 DOSE PACK | TABLET, ORALLY DISINTEGRATING | 1 | 5 | |
| 62756-356-66 | ONDANSETRON | 10 in 1 BLISTER PACK | TABLET, ORALLY DISINTEGRATING | 10 | 5 | |
| 62756-356-83 | ONDANSETRON | 30 in 1 BOTTLE | TABLET, ORALLY DISINTEGRATING | 30 | 5 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 62756-356-64 | EA - Each | 62756-356 | 99af3801-0b2d-4e82-bcd1-87f45821e8db | 1 | 2012-07-24 |
| 62756-356-66 | EA - Each | 62756-356 | ae8758cf-37c2-468a-bdaa-09af7f5654dd | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 62756-356 | ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED ONDANSETRON TABLET, ORALLY DISINTEGRATING [SUN PHARMACEUTICAL INDUSTRIES, INC.] | 17 | Current NDC, Legacy NDC, 5 package rows | 20250419_92c758a3-e749-4a15-be4b-ee30b364b2b0.zip |
| 62756-356 | ONDANSETRON TABLET, ORALLY DISINTEGRATING [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] | 5 | Current NDC, Legacy NDC, 5 package rows | 20150505_52dc6871-47d3-11dc-99cc-f742b487c00e.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 |
| 312087 | ondansetron 8 MG Disintegrating Oral Tablet | PSN | 384a5cfb-05dd-2b79-73f4-a01a47a9eb3e | 13 |
| 198052 | ondansetron HCl 4 MG Oral Tablet | PSN | 384a5cfb-05dd-2b79-73f4-a01a47a9eb3e | 13 |
| 198052 | ondansetron 4 MG Oral Tablet | SCD | 384a5cfb-05dd-2b79-73f4-a01a47a9eb3e | 13 |
| 312087 | ondansetron 8 MG Disintegrating Oral Tablet | SCD | 384a5cfb-05dd-2b79-73f4-a01a47a9eb3e | 13 |
| 198052 | ondansetron 4 MG (as ondansetron HCl dihydrate 5 MG) Oral Tablet | SY | 384a5cfb-05dd-2b79-73f4-a01a47a9eb3e | 13 |
| 104894 | ondansetron 4 MG Disintegrating Oral Tablet | PSN | 52dc6871-47d3-11dc-99cc-f742b487c00e | 5 |
| 312087 | ondansetron 8 MG Disintegrating Oral Tablet | PSN | 52dc6871-47d3-11dc-99cc-f742b487c00e | 5 |
| 312087 | ondansetron 8 MG Disintegrating Oral Tablet | PSN | 4feb4b89-2d2f-4a9c-a4f4-5ae3e26281b6 | 5 |
| 104894 | ondansetron 4 MG Disintegrating Oral Tablet | SCD | 52dc6871-47d3-11dc-99cc-f742b487c00e | 5 |
| 312087 | ondansetron 8 MG Disintegrating Oral Tablet | SCD | 52dc6871-47d3-11dc-99cc-f742b487c00e | 5 |
| 312087 | ondansetron 8 MG Disintegrating Oral Tablet | SCD | 4feb4b89-2d2f-4a9c-a4f4-5ae3e26281b6 | 5 |
| 312087 | ondansetron 8 MG Disintegrating Oral Tablet | PSN | a1dd7420-dd81-2c8e-e053-2995a90ac8e6 | 3 |
| 312087 | ondansetron 8 MG Disintegrating Oral Tablet | PSN | b297c163-2052-cb22-e053-2995a90a8289 | 3 |
| 312087 | ondansetron 8 MG Disintegrating Oral Tablet | SCD | a1dd7420-dd81-2c8e-e053-2995a90ac8e6 | 3 |
| 312087 | ondansetron 8 MG Disintegrating Oral Tablet | SCD | b297c163-2052-cb22-e053-2995a90a8289 | 3 |
| 104894 | ondansetron 4 MG Disintegrating Oral Tablet | PSN | 6c450150-a7a4-46f3-b62a-848eeefada06 | 1 |
| 312087 | ondansetron 8 MG Disintegrating Oral Tablet | PSN | 6c450150-a7a4-46f3-b62a-848eeefada06 | 1 |
| 312087 | ondansetron 8 MG Disintegrating Oral Tablet | PSN | a799a6ec-917a-33c9-e053-2995a90a2df3 | 1 |
| 312087 | ondansetron 8 MG Disintegrating Oral Tablet | PSN | d9bc4bcd-8466-3b02-e053-2a95a90a635f | 1 |
| 312087 | ondansetron 8 MG Disintegrating Oral Tablet | PSN | 6285d09e-8f9b-419b-80fb-be7eb2523490 | 1 |
| 312087 | ondansetron 8 MG Disintegrating Oral Tablet | PSN | 1fc05030-6521-6d38-e063-6294a90a0f8b | 1 |
| 312087 | ondansetron 8 MG Disintegrating Oral Tablet | PSN | 1fbfe3f9-e0da-a3a2-e063-6294a90ab6aa | 1 |
| 104894 | ondansetron 4 MG Disintegrating Oral Tablet | SCD | 6c450150-a7a4-46f3-b62a-848eeefada06 | 1 |
| 312087 | ondansetron 8 MG Disintegrating Oral Tablet | SCD | d9bc4bcd-8466-3b02-e053-2a95a90a635f | 1 |
| 312087 | ondansetron 8 MG Disintegrating Oral Tablet | SCD | 1fbfe3f9-e0da-a3a2-e063-6294a90ab6aa | 1 |
| 312087 | ondansetron 8 MG Disintegrating Oral Tablet | SCD | a799a6ec-917a-33c9-e053-2995a90a2df3 | 1 |
| 312087 | ondansetron 8 MG Disintegrating Oral Tablet | SCD | 6c450150-a7a4-46f3-b62a-848eeefada06 | 1 |
| 312087 | ondansetron 8 MG Disintegrating Oral Tablet | SCD | 6285d09e-8f9b-419b-80fb-be7eb2523490 | 1 |
| 312087 | ondansetron 8 MG Disintegrating Oral Tablet | SCD | 1fc05030-6521-6d38-e063-6294a90a0f8b | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 62756-356-64 | 62756035664 | 3 BLISTER PACK in 1 DOSE PACK (62756-356-64) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK | 3 blister pack | 2007-08-02 | 0000-00-00 | No | No | Current |
| 62756-356-66 | 62756035666 | 1 BLISTER PACK in 1 DOSE PACK (62756-356-66) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK | 1 blister pack | 2007-08-02 | 0000-00-00 | No | No | Current |
| 62756-356-83 | 62756035683 | 30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (62756-356-83) | 2007-08-02 | 0000-00-00 | No | No | Current |