Oxycodone Hydrochloride
- Product NDC
- 66689-403
- 11-digit product format
- 666890403
- Labeler code
- 66689
- Product ID
- 66689-403_6f0d315a-4d02-4548-b993-ba648c596bc3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Oxycodone Hydrochloride
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- VistaPharm, Inc.
- Application
- NDA201194
- Marketing category
- NDA
- Marketing start
- 2012-03-15
- Marketing end
- 0000-00-00
- Substance
- OXYCODONE HYDROCHLORIDE
- Active strength
- 5 mg/5mL
- Pharmacologic classes
- Full Opioid Agonists [MoA], Opioid Agonist [EPC]
- DEA schedule
- CII
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 66689-403-16 | 2024-01-30 | C162847 | 48780-1 | 1030e364-fb51-111a-e063-dadaa90a10e2 | d7dceba3-96dc-4593-bc8f-318052bdb520 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 66689-403-16 | ML - Milliliter | 66689-403 | 5ebc6888-7b67-44e6-8bfa-98bd26f1dfce | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| OXYCODONE HYDROCHLORIDE | ACTIVE INGREDIENT | C1ENJ2TE6C | OXYCODONE HYDROCHLORIDE SOLUTION [VISTAPHARM INC.] | 1 | |
| OXYCODONE | ACTIVE MOIETY | CD35PMG570 | OXYCODONE HYDROCHLORIDE SOLUTION [VISTAPHARM INC.] | 1 | |
| ANHYDROUS CITRIC ACID | INACTIVE INGREDIENT | XF417D3PSL | OXYCODONE HYDROCHLORIDE SOLUTION [VISTAPHARM INC.] | 1 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | OXYCODONE HYDROCHLORIDE SOLUTION [VISTAPHARM INC.] | 1 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | OXYCODONE HYDROCHLORIDE SOLUTION [VISTAPHARM INC.] | 1 | |
| POLOXAMER 188 | INACTIVE INGREDIENT | LQA7B6G8JG | OXYCODONE HYDROCHLORIDE SOLUTION [VISTAPHARM INC.] | 1 | |
| SODIUM BENZOATE | INACTIVE INGREDIENT | OJ245FE5EU | OXYCODONE HYDROCHLORIDE SOLUTION [VISTAPHARM INC.] | 1 | |
| SORBITOL | INACTIVE INGREDIENT | 506T60A25R | OXYCODONE HYDROCHLORIDE SOLUTION [VISTAPHARM INC.] | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | OXYCODONE HYDROCHLORIDE SOLUTION [VISTAPHARM INC.] | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1049604 | oxyCODONE HCl 5 MG in 5 mL Oral Solution | PSN | 6a4d8151-f28e-366b-e053-2991aa0a1359 | 6 |
| 1049604 | oxycodone hydrochloride 1 MG/ML Oral Solution | SCD | 6a4d8151-f28e-366b-e053-2991aa0a1359 | 6 |
| 1049604 | oxycodone hydrochloride 5 MG per 5 ML Oral Solution | SY | 6a4d8151-f28e-366b-e053-2991aa0a1359 | 6 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 66689-403-16 | 66689040316 | 500 mL in 1 BOTTLE (66689-403-16) | 500 ml | 2012-03-15 | 0000-00-00 | No | No | Current |