Prescription drug · ANDA
Tramadol Hydrochloride NDC 76420-732
Tramadol hydrochloride 25 mg/1 · Tablet, Coated · Oral · Asclemed USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76420-732-00 | 76420073200 | 1000 TABLET, COATED in 1 BOTTLE (76420-732-00)Marketed from May 22, 2024 | |
| 76420-732-01 | 76420073201 | 100 TABLET, COATED in 1 BOTTLE (76420-732-01)Marketed from May 22, 2024 | |
| 76420-732-05 | 76420073205 | 500 TABLET, COATED in 1 BOTTLE (76420-732-05)Marketed from May 22, 2024 | |
| 76420-732-30 | 76420073230 | 30 TABLET, COATED in 1 BOTTLE (76420-732-30)Marketed from May 22, 2024 | |
| 76420-732-60 | 76420073260 | 60 TABLET, COATED in 1 BOTTLE (76420-732-60)Marketed from May 22, 2024 | |
| 76420-732-90 | 76420073290 | 90 TABLET, COATED in 1 BOTTLE (76420-732-90)Marketed from May 22, 2024 |
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 — 25 mg/1
- Dosage form
- Tablet, Coated
- Route
- Oral
- Labeler
- Asclemed USA, Inc.
- 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 76420-732_3c537239-67e9-1101-e063-6394a90a397fSPL ID 3c537239-67e9-1101-e063-6394a90a397fSPL set ID 6a60bd36-7dcc-49c3-b6de-b263fdaa312cRxCUI 835603, 2179635, 2670390UNII 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
N476420073200followed by a unit qualifier and the quantityPackage 76420-0732-00. 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
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
Tramadol Hydrochloride Tablets, USP are indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1) ] , reserve tramadol hydrochloride tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]: Have not been tolerated or are not expected to be tolerated. Have not provided adequate analgesia or are not expected to provide adequate analgesia. Tramadol hydrochloride is an opioid agonist indicated in adults for the management of…
Excerpt only. Read the full label for complete information.
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 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 50 mg/1 | Tablet, CoatedOral | DirectRx | 72189-311 |
| 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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