Ondansetron
- Product NDC
- 16714-671
- 11-digit product format
- 167140671
- Labeler code
- 16714
- Product ID
- 16714-671_add9275d-a837-48f4-ab0b-01fc50e4545f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ondansetron Hydrochloride
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- NorthStar Rx LLC
- Application
- ANDA078776
- Marketing category
- ANDA
- Marketing start
- 2007-11-28
- Substance
- ONDANSETRON HYDROCHLORIDE
- Active strength
- 4 mg/5mL
- 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 HYDROCHLORIDE | 4 mg/5mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | NMH84OZK2B |
| Rxcui | 312085 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| d9bd4853-037c-6968-f4d4-9bb9a0efd1ea | Product name | 2 | 20250722 |
| e2db08c6-133f-4f4f-afb4-e90a2418d6f6 | Product name | 1 | 20230320 |
| c6f86816-7da6-43ea-8c25-ac9758311cc5 | Product name | 1 | 20220118 |
| ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906 | Product name | 7 | 20210625 |
| f52be47f-7aa7-46c0-b1fa-50c18dd50206 | Product name | 1 | 20201029 |
| 32e23bc9-ce14-4555-bb6d-bcb654d7d296 | Product name | 1 | 20201015 |
| e459f50a-1553-4aab-b6bd-1e5f0c211c49 | Product name | 1 | 20201015 |
| 11ed6f83-cdd2-4637-8379-b1a1d3ae3cde | Product name | 1 | 20181101 |
| 86c45a79-b9f0-4476-a27c-6e10db098497 | Product name | 1 | 20180125 |
| 909480fe-0d18-c1c1-a658-0bd9a7131822 | Product name | 5 | 20170829 |
| 252e11b6-1a9a-4283-a242-df2c129c496d | Product name | 3 | 20170717 |
| d5e51f11-ad28-caa4-4b49-4143974782ad | Product name | 1 | 20150831 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 16714-671-01 | Ondansetron | 1 in 1 CARTON | SOLUTION | 1 | 14 | |
| 16714-671-01 | Ondansetron | 50 mL in 1 BOTTLE | SOLUTION | 50 | 14 | |
| 16714-671-02 | Ondansetron | 50 mL in 1 BOTTLE, PLASTIC | SOLUTION | 50 | 14 | |
| 16714-671-02 | Ondansetron | 1 in 1 CARTON | SOLUTION | 1 | 14 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 16714-671-01 | ML - Milliliter | 16714-671 | f85fd36b-6b85-4724-a2e5-dbdcc978e0cd | 1 | 2012-07-24 |
| 16714-671-02 | ML - Milliliter | 16714-671 | 1634201f-a898-4682-b817-79c812875277 | 1 | 2015-05-05 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| ONDANSETRON HYDROCHLORIDE | ACTIVE INGREDIENT | NMH84OZK2B | ONDANSETRON (ONDANSETRON HYDROCHLORIDE) SOLUTION [NORTHSTAR RX LLC] | 6 | |
| ONDANSETRON | ACTIVE MOIETY | 4AF302ESOS | ONDANSETRON (ONDANSETRON HYDROCHLORIDE) SOLUTION [NORTHSTAR RX LLC] | 6 | |
| ANHYDROUS CITRIC ACID | INACTIVE INGREDIENT | XF417D3PSL | ONDANSETRON (ONDANSETRON HYDROCHLORIDE) SOLUTION [NORTHSTAR RX LLC] | 6 | |
| EDETATE DISODIUM | INACTIVE INGREDIENT | 7FLD91C86K | ONDANSETRON (ONDANSETRON HYDROCHLORIDE) SOLUTION [NORTHSTAR RX LLC] | 6 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | ONDANSETRON (ONDANSETRON HYDROCHLORIDE) SOLUTION [NORTHSTAR RX LLC] | 6 | |
| SODIUM BENZOATE | INACTIVE INGREDIENT | OJ245FE5EU | ONDANSETRON (ONDANSETRON HYDROCHLORIDE) SOLUTION [NORTHSTAR RX LLC] | 6 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | ONDANSETRON (ONDANSETRON HYDROCHLORIDE) SOLUTION [NORTHSTAR RX LLC] | 6 | |
| TRISODIUM CITRATE DIHYDRATE | INACTIVE INGREDIENT | B22547B95K | ONDANSETRON (ONDANSETRON HYDROCHLORIDE) SOLUTION [NORTHSTAR RX LLC] | 6 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 312085 | ondansetron HCl 4 MG in 5 mL Oral Solution | PSN | ac3dfb81-a4c7-4147-9374-c234153b7c51 | 14 |
| 312085 | ondansetron 0.8 MG/ML Oral Solution | SCD | ac3dfb81-a4c7-4147-9374-c234153b7c51 | 14 |
| 312085 | ondansetron (as ondansetron HCl dihydrate) 4 MG per 5 ML Oral Solution | SY | ac3dfb81-a4c7-4147-9374-c234153b7c51 | 14 |
| 312085 | ondansetron 4 MG per 5 ML Oral Solution | SY | ac3dfb81-a4c7-4147-9374-c234153b7c51 | 14 |
| 312085 | ondansetron HCl 4 MG in 5 mL Oral Solution | PSN | 1b406d22-f1bf-460d-e063-6294a90a6b6f | 1 |
| 312085 | ondansetron HCl 4 MG in 5 mL Oral Solution | PSN | 41d71d26-0d42-b368-e063-6394a90add43 | 1 |
| 312085 | ondansetron 0.8 MG/ML Oral Solution | SCD | 1b406d22-f1bf-460d-e063-6294a90a6b6f | 1 |
| 312085 | ondansetron 0.8 MG/ML Oral Solution | SCD | 41d71d26-0d42-b368-e063-6394a90add43 | 1 |
| 312085 | ondansetron (as ondansetron HCl dihydrate) 4 MG per 5 ML Oral Solution | SY | 1b406d22-f1bf-460d-e063-6294a90a6b6f | 1 |
| 312085 | ondansetron (as ondansetron HCl dihydrate) 4 MG per 5 ML Oral Solution | SY | 41d71d26-0d42-b368-e063-6394a90add43 | 1 |
| 312085 | ondansetron 4 MG per 5 ML Oral Solution | SY | 1b406d22-f1bf-460d-e063-6294a90a6b6f | 1 |
| 312085 | ondansetron 4 MG per 5 ML Oral Solution | SY | 41d71d26-0d42-b368-e063-6394a90add43 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 16714-671-01 | 16714067101 | 1 BOTTLE in 1 CARTON (16714-671-01) > 50 mL in 1 BOTTLE | 1 bottle | 2007-11-28 | 0000-00-00 | No | No | Current |
| 16714-671-02 | 16714067102 | 1 BOTTLE, PLASTIC in 1 CARTON (16714-671-02) / 50 mL in 1 BOTTLE, PLASTIC | 2007-11-28 | 0000-00-00 | No | No | Current |