Nalocet
- Product NDC
- 72245-193
- 11-digit product format
- 722450193
- Labeler code
- 72245
- Product ID
- 72245-193_502384f0-4ffd-5d16-e063-6394a90ad304
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- oxycodone and acetaminophen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Forte Bio-Pharma LLC
- Application
- ANDA040608
- Marketing category
- ANDA
- Marketing start
- 2018-05-23
- Substance
- ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
- Active strength
- 300; 2.5 mg/1; mg/1
- Pharmacologic classes
- Full Opioid Agonists [MoA], Opioid Agonist [EPC]
- DEA schedule
- CII
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Nalocet
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ACETAMINOPHEN | 300 mg/1 |
| OXYCODONE HYDROCHLORIDE | 2.5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 362O9ITL9D, C1ENJ2TE6C |
| Rxcui | 1037259, 2045500 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72245-193-03 | Nalocet | 30 in 1 BOTTLE, PLASTIC | TABLET | 30 | | 8 |
| 72245-193-10 | Nalocet | 100 in 1 BOTTLE, PLASTIC | TABLET | 100 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72245-193 | NALOCET (OXYCODONE AND ACETAMINOPHEN) TABLET [FORTE BIO-PHARMA LLC] | 6 | Current NDC, Legacy NDC, 2 package rows | 20240928_f5f7dfca-a5c7-4445-8a5e-9ec62f33f5be.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 72245-193-03 | 72245019303 | 30 TABLET in 1 BOTTLE, PLASTIC (72245-193-03) | 30 tablet | 2018-05-23 | 0000-00-00 | No | No | Current |
| 72245-193-10 | 72245019310 | 100 TABLET in 1 BOTTLE, PLASTIC (72245-193-10) | 100 tablet | 2018-05-23 | 0000-00-00 | No | No | Current |