TRAMADOL HYDROCHLORIDE
- Product NDC
- 27808-301
- 11-digit product format
- 278080301
- Labeler code
- 27808
- Product ID
- 27808-301_18541c83-30aa-4df4-9d72-915629ee01f9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- TRAMADOL HYDROCHLORIDE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Cranbury Pharmaceuticals, LLC
- Application
- ANDA091498
- Marketing category
- ANDA
- Marketing start
- 2024-12-22
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- TRAMADOL HYDROCHLORIDE
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TRAMADOL HYDROCHLORIDE | 50 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 9N7R477WCK |
| Rxcui | 835603 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 27808-301-01 | TRAMADOL HYDROCHLORIDE | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 3 |
| 27808-301-02 | TRAMADOL HYDROCHLORIDE | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 3 |
| 27808-301-03 | TRAMADOL HYDROCHLORIDE | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 27808-301 | TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [CRANBURY PHARMACEUTICALS, LLC] | 3 | Current NDC, 3 package rows | 20250418_1d4af58f-17f3-4cbd-870c-098ace954872.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 27808-301-01 | 27808030101 | 100 TABLET, FILM COATED in 1 BOTTLE (27808-301-01) | 2024-12-22 | No | No | Current |
| 27808-301-02 | 27808030102 | 500 TABLET, FILM COATED in 1 BOTTLE (27808-301-02) | 2024-12-22 | No | No | Current |
| 27808-301-03 | 27808030103 | 1000 TABLET, FILM COATED in 1 BOTTLE (27808-301-03) | 2024-12-22 | No | No | Current |