Prescription drug · ANDA
Tramadol Hydrochloride NDC 72189-311
Tramadol hydrochloride 50 mg/1 · Tablet, Coated · Oral · DirectRx
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72189-311-12 | 72189031112 | 12 TABLET, COATED in 1 BOTTLE (72189-311-12)Marketed from Jan 12, 2022 | |
| 72189-311-20 | 72189031120 | 20 TABLET, COATED in 1 BOTTLE (72189-311-20)Marketed from Jan 12, 2022 | |
| 72189-311-30 | 72189031130 | 30 TABLET, COATED in 1 BOTTLE (72189-311-30)Marketed from Jan 12, 2022 | |
| 72189-311-40 | 72189031140 | 40 TABLET, COATED in 1 BOTTLE (72189-311-40)Marketed from Jan 12, 2022 | |
| 72189-311-60 | 72189031160 | 60 TABLET, COATED in 1 BOTTLE (72189-311-60)Marketed from Jan 12, 2022 | |
| 72189-311-72 | 72189031172 | 120 TABLET, COATED in 1 BOTTLE (72189-311-72)Marketed from Jan 12, 2022 | |
| 72189-311-82 | 72189031182 | 180 TABLET, COATED in 1 BOTTLE (72189-311-82)Marketed from Jan 12, 2022 | |
| 72189-311-84 | 72189031184 | 240 TABLET, COATED in 1 BOTTLE (72189-311-84)Marketed from Jan 12, 2022 | |
| 72189-311-90 | 72189031190 | 90 TABLET, COATED in 1 BOTTLE (72189-311-90)Marketed from Jan 12, 2022 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Tramadol Hydrochloride
- Generic name (nonproprietary)
- tramadol hydrochloride
- Active ingredients
- Tramadol hydrochloride — 50 mg/1
- Dosage form
- Tablet, Coated
- Route
- Oral
- Labeler
- DirectRx
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208708
- Marketing start
- Listing expires
- DEA schedule
- CIV
- Other FDA classes
- Full Opioid Agonists (Mechanism)
- Identifiers
- Product ID 72189-311_2c3cf1d7-38f5-4d25-e063-6294a90aa8cdSPL ID 2c3cf1d7-38f5-4d25-e063-6294a90aa8cdSPL set ID d5685c80-c84d-d0a1-e053-2995a90afc54RxCUI 835603UNII 9N7R477WCK
- Pharmacologic class
- Opioid Agonist
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N472189031112followed by a unit qualifier and the quantityPackage 72189-0311-12. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Label details couldn’t be retrieved right now. Open the label on DailyMed.
Other NDCs under ANDA 208708
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Tramadol Hydrochloride | Tramadol hydrochloride 50 mg/1 | Tablet, CoatedOral | REMEDYREPACK INC. | 70518-4713 |
| Tramadol Hydrochloride | Tramadol hydrochloride 50 mg/1 | Tablet, CoatedOral | Proficient Rx LP | 82804-142 |
| Tramadol Hydrochloride | Tramadol hydrochloride 50 mg/1 | Tablet, CoatedOral | Preferred Pharmaceuticals Inc. | 68788-8121 |
| Tramadol Hydrochloride | Tramadol hydrochloride 100 mg/1 | Tablet, CoatedOral | Advagen Pharma Limited | 72888-008 |
| Tramadol Hydrochloride | Tramadol hydrochloride 100 mg/1 | Tablet, CoatedOral | Coupler LLC | 67046-1541 |
| Tramadol Hydrochloride | Tramadol hydrochloride 25 mg/1 | Tablet, CoatedOral | Asclemed USA, Inc. | 76420-732 |
| Tramadol Hydrochloride | Tramadol hydrochloride 50 mg/1 | Tablet, CoatedOral | Asclemed USA, Inc. | 76420-733 |
| Tramadol Hydrochloride | Tramadol hydrochloride 100 mg/1 | Tablet, CoatedOral | Asclemed USA, Inc. | 76420-734 |
| Tramadol Hydrochloride | Tramadol hydrochloride 50 mg/1 | Tablet, CoatedOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0274 |
| Tramadol Hydrochloride | Tramadol hydrochloride 50 mg/1 | Tablet, CoatedOral | TRUPHARMA LLC | 52817-195 |
| Tramadol Hydrochloride | Tramadol hydrochloride 100 mg/1 | Tablet, CoatedOral | TRUPHARMA LLC | 52817-196 |
| Tramadol Hydrochloride | Tramadol hydrochloride 50 mg/1 | Tablet, CoatedOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0276 |
| Tramadol Hydrochloride | Tramadol hydrochloride 50 mg/1 | Tablet, CoatedOral | Bryant Ranch Prepack | 71335-2721 |
| Tramadol Hydrochloride | Tramadol hydrochloride 50 mg/1 | Tablet, CoatedOral | Advagen Pharma Limited | 72888-080 |
| Tramadol Hydrochloride | Tramadol hydrochloride 50 mg/1 | Tablet, CoatedOral | Bryant Ranch Prepack | 71335-9658 |
| Tramadol Hydrochloride | Tramadol hydrochloride 50 mg/1 | Tablet, CoatedOral | REMEDYREPACK INC. | 70518-3824 |
| Tramadol Hydrochloride | Tramadol hydrochloride 50 mg/1 | Tablet, CoatedOral | Northwind Health Company, LLC | 82868-110 |
| Tramadol Hydrochloride | Tramadol hydrochloride 25 mg/1 | Tablet, CoatedOral | Advagen Pharma Limited | 72888-162 |
| Tramadol Hydrochloride | Tramadol hydrochloride 75 mg/1 | Tablet, CoatedOral | Advagen Pharma Limited | 72888-163 |
| Tramadol Hydrochloride | Tramadol hydrochloride 50 mg/1 | Tablet, CoatedOral | RedPharm Drug Inc | 67296-1834 |
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