Xodol
- Product NDC
- 42254-291
- 11-digit product format
- 422540291
- Labeler code
- 42254
- Product ID
- 42254-291_7e233783-c467-4ca7-8849-7e1526bb2de0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- hydrocodone bitartrate and acetaminophen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Rebel Distributors Corp
- Application
- ANDA040658
- Marketing category
- ANDA
- Marketing start
- 2011-10-10
- Marketing end
- 0000-00-00
- Substance
- HYDROCODONE BITARTRATE; ACETAMINOPHEN
- Active strength
- 5 mg/1; mg/1
- Pharmacologic classes
- Opioid Agonist [EPC],Opioid Agonists [MoA]
- DEA schedule
- CIII
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 42254-291-30 | 2019-09-24 | C162847 | 48780-1 | 9350213a-3cbc-c013-e053-90daa90a1393 | Xodol |
| 42254-291-60 | 2019-09-24 | C162847 | 48780-1 | 9350213a-3cbc-c013-e053-90daa90a1393 | Xodol |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 42254-291-30 | Xodol | 30 in 1 BOTTLE | TABLET | 30 | 1 | |
| 42254-291-60 | Xodol | 60 in 1 BOTTLE | TABLET | 60 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 42254-291-30 | EA - Each | 42254-291 | a1b6425c-0377-4a99-967a-40b3cca30291 | 1 | 2013-04-01 |
| 42254-291-60 | EA - Each | 42254-291 | 596df10b-63d7-414a-bddf-c6802f3c86af | 1 | 2013-04-01 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 856980 | HYDROcodone bitartrate 10 MG / acetaminophen 300 MG Oral Tablet | PSN | 7e233783-c467-4ca7-8849-7e1526bb2de0 | 1 |
| 856987 | HYDROcodone bitartrate 5 MG / acetaminophen 300 MG Oral Tablet | PSN | 7e233783-c467-4ca7-8849-7e1526bb2de0 | 1 |
| 856984 | acetaminophen 300 MG / hydrocodone bitartrate 10 MG Oral Tablet [Xodol] | SBD | 7e233783-c467-4ca7-8849-7e1526bb2de0 | 1 |
| 856991 | acetaminophen 300 MG / hydrocodone bitartrate 5 MG Oral Tablet [Xodol] | SBD | 7e233783-c467-4ca7-8849-7e1526bb2de0 | 1 |
| 856980 | acetaminophen 300 MG / hydrocodone bitartrate 10 MG Oral Tablet | SCD | 7e233783-c467-4ca7-8849-7e1526bb2de0 | 1 |
| 856987 | acetaminophen 300 MG / hydrocodone bitartrate 5 MG Oral Tablet | SCD | 7e233783-c467-4ca7-8849-7e1526bb2de0 | 1 |
| 856980 | APAP 300 MG / hydrocodone bitartrate 10 MG Oral Tablet | SY | 7e233783-c467-4ca7-8849-7e1526bb2de0 | 1 |
| 856984 | APAP 300 MG / Hydrocodone Bitartrate 10 MG Oral Tablet [Xodol] | SY | 7e233783-c467-4ca7-8849-7e1526bb2de0 | 1 |
| 856987 | APAP 300 MG / hydrocodone bitartrate 5 MG Oral Tablet | SY | 7e233783-c467-4ca7-8849-7e1526bb2de0 | 1 |
| 856991 | APAP 300 MG / Hydrocodone Bitartrate 5 MG Oral Tablet [Xodol] | SY | 7e233783-c467-4ca7-8849-7e1526bb2de0 | 1 |
| 856984 | Xodol (APAP 300 MG / hydrocodone bitartrate 10 MG) Oral Tablet | SY | 7e233783-c467-4ca7-8849-7e1526bb2de0 | 1 |
| 856991 | Xodol (APAP 300 MG / hydrocodone bitartrate 5 MG) Oral Tablet | SY | 7e233783-c467-4ca7-8849-7e1526bb2de0 | 1 |
| 856984 | Xodol 10/300 Oral Tablet | SY | 7e233783-c467-4ca7-8849-7e1526bb2de0 | 1 |
| 856991 | Xodol 5/300 Oral Tablet | SY | 7e233783-c467-4ca7-8849-7e1526bb2de0 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 42254-291-30 | 42254029130 | 30 in 1 BOTTLE | Historical |
| 42254-291-60 | 42254029160 | 60 in 1 BOTTLE | Historical |