tramadol hydrochloride
- Product NDC
- 68134-402
- 11-digit product format
- 681340402
- Labeler code
- 68134
- Product ID
- 68134-402_dca135cf-1ae0-a00e-e053-2995a90a1203
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- tramadol hydrochloride
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Palmetto Pharmaceuticals, Inc.
- Application
- NDA214044
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2020-09-11
- Marketing end
- 0000-00-00
- Substance
- TRAMADOL HYDROCHLORIDE
- Active strength
- 5 mg/mL
- Pharmacologic classes
- Full Opioid Agonists [MoA], Opioid Agonist [EPC]
- DEA schedule
- CIV
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68134-402-05 | tramadol hydrochloride | 5 mL in 1 CUP, UNIT-DOSE | SOLUTION | 5 | | 5 |
| 68134-402-40 | tramadol hydrochloride | 10 in 1 TRAY | SOLUTION | 10 | | 5 |
| 68134-402-40 | tramadol hydrochloride | 4 in 1 CASE | SOLUTION | 4 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68134-402 | TRAMADOL HYDROCHLORIDE SOLUTION [PALMETTO PHARMACEUTICALS, INC.] | 5 | Legacy NDC, 3 package rows | 20241210_2804c640-9d47-4b40-b58b-da321b79cf39.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 |
|---|
| 68134-402-05 | 68134040205 | 5 mL in 1 CUP, UNIT-DOSE | 5 ml | | | | | Historical |
| 68134-402-40 | 68134040240 | 4 TRAY in 1 CASE (68134-402-40) > 10 CUP, UNIT-DOSE in 1 TRAY > 5 mL in 1 CUP, UNIT-DOSE (68134-402-05) | 4 tray | 2021-09-16 | 0000-00-00 | No | No | Current |