tramadol hydrochloride
- Product NDC
- 71335-2518
- 11-digit product format
- 713352518
- Labeler code
- 71335
- Product ID
- 71335-2518_e37a5865-f78e-41d4-9d0a-b7ec7bcd0807
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- tramadol hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA202075
- Marketing category
- ANDA
- Marketing start
- 2018-03-01
- Substance
- TRAMADOL HYDROCHLORIDE
- Active strength
- 50 mg/1
- Pharmacologic classes
- Full Opioid Agonists [MoA], Opioid Agonist [EPC]
- DEA schedule
- CIV
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
openFDA Listing Details
- Product ID
- 71335-2518_e37a5865-f78e-41d4-9d0a-b7ec7bcd0807
- SPL ID
- e37a5865-f78e-41d4-9d0a-b7ec7bcd0807
- Product type
- HUMAN PRESCRIPTION DRUG
- Finished product
- Yes
- Brand name base
- tramadol hydrochloride
- Generic name
- tramadol hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Marketing start
- 2018-03-01
- Marketing category
- ANDA
- Application number
- ANDA202075
- Pharmacologic classes
- Full Opioid Agonists [MoA]; Opioid Agonist [EPC]
- DEA schedule
- CIV
- Listing expiration
- 2026-12-31
openFDA Active Ingredients
| Ingredient | Strength |
|---|
| TRAMADOL HYDROCHLORIDE | 50 mg/1 |
openFDA Harmonized Identifiers
| Field | Values |
|---|
| Unii | 9N7R477WCK |
| Rxcui | 835603 |
| Spl Set Id | 6ebc5864-c222-4400-a9b2-f66fd6fb0da6 |
| Manufacturer Name | Bryant Ranch Prepack |
openFDA Package Details
| Package NDC | Description | Marketing start | Sample |
|---|
| 71335-2518-0 | 50 TABLET in 1 BOTTLE (71335-2518-0) | 2024-11-04 | No |
| 71335-2518-1 | 30 TABLET in 1 BOTTLE (71335-2518-1) | 2024-11-04 | No |
| 71335-2518-2 | 20 TABLET in 1 BOTTLE (71335-2518-2) | 2024-11-04 | No |
| 71335-2518-3 | 90 TABLET in 1 BOTTLE (71335-2518-3) | 2024-11-04 | No |
| 71335-2518-4 | 60 TABLET in 1 BOTTLE (71335-2518-4) | 2024-11-04 | No |
| 71335-2518-5 | 120 TABLET in 1 BOTTLE (71335-2518-5) | 2024-11-04 | No |
| 71335-2518-6 | 180 TABLET in 1 BOTTLE (71335-2518-6) | 2024-11-04 | No |
| 71335-2518-7 | 40 TABLET in 1 BOTTLE (71335-2518-7) | 2024-11-04 | No |
| 71335-2518-8 | 100 TABLET in 1 BOTTLE (71335-2518-8) | 2024-11-04 | No |
| 71335-2518-9 | 15 TABLET in 1 BOTTLE (71335-2518-9) | 2024-11-04 | No |
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 9N7R477WCK | TRAMADOL HYDROCHLORIDE | 36282-47-0 | TRAMADOL HYDROCHLORIDE |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 71335-2518-0 | 71335251800 | 50 TABLET in 1 BOTTLE (71335-2518-0) | 50 tablet | 2024-11-04 | No | No | Historical |
| 71335-2518-1 | 71335251801 | 30 TABLET in 1 BOTTLE (71335-2518-1) | 30 tablet | 2024-11-04 | No | No | Historical |
| 71335-2518-2 | 71335251802 | 20 TABLET in 1 BOTTLE (71335-2518-2) | 20 tablet | 2024-11-04 | No | No | Historical |
| 71335-2518-3 | 71335251803 | 90 TABLET in 1 BOTTLE (71335-2518-3) | 90 tablet | 2024-11-04 | No | No | Historical |
| 71335-2518-4 | 71335251804 | 60 TABLET in 1 BOTTLE (71335-2518-4) | 60 tablet | 2024-11-04 | No | No | Historical |
| 71335-2518-5 | 71335251805 | 120 TABLET in 1 BOTTLE (71335-2518-5) | 120 tablet | 2024-11-04 | No | No | Historical |
| 71335-2518-6 | 71335251806 | 180 TABLET in 1 BOTTLE (71335-2518-6) | 180 tablet | 2024-11-04 | No | No | Historical |
| 71335-2518-7 | 71335251807 | 40 TABLET in 1 BOTTLE (71335-2518-7) | 40 tablet | 2024-11-04 | No | No | Historical |
| 71335-2518-8 | 71335251808 | 100 TABLET in 1 BOTTLE (71335-2518-8) | 100 tablet | 2024-11-04 | No | No | Historical |
| 71335-2518-9 | 71335251809 | 15 TABLET in 1 BOTTLE (71335-2518-9) | 15 tablet | 2024-11-04 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| tramadol hydrochloride | Bryant Ranch Prepack | 2024-11-04 | HUMAN PRESCRIPTION DRUG LABEL | 1 |