Prescription drug · ANDA
Tramadol Hydrochloride NDC 27808-301
Tramadol hydrochloride 50 mg/1 · Tablet, Film coated · Oral · Cranbury Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 27808-301-01 | 27808030101 | 100 TABLET, FILM COATED in 1 BOTTLE (27808-301-01)Marketed from Dec 22, 2024 | |
| 27808-301-02 | 27808030102 | 500 TABLET, FILM COATED in 1 BOTTLE (27808-301-02)Marketed from Dec 22, 2024 | |
| 27808-301-03 | 27808030103 | 1000 TABLET, FILM COATED in 1 BOTTLE (27808-301-03)Marketed from Dec 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 — 50 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Cranbury Pharmaceuticals, LLCNDC labeler code 27808
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091498
- Marketing start
- Listing expires
- DEA schedule
- CIV
- Other FDA classes
- Full Opioid Agonists (Mechanism)
- Identifiers
- Product ID 27808-301_18541c83-30aa-4df4-9d72-915629ee01f9SPL ID 18541c83-30aa-4df4-9d72-915629ee01f9SPL set ID 1d4af58f-17f3-4cbd-870c-098ace954872RxCUI 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
N427808030101followed by a unit qualifier and the quantityPackage 27808-0301-01. 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 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, which can occur at any dosage or duration [see Warnings and Precautions (5.1) ] , reserve tramadol hydrochloride tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products): 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 tablets should not b…
Excerpt only. Read the full label for complete information.
About NDC 27808-301
- What is NDC 27808-301?
- 27808-301 is the product NDC for Tramadol Hydrochloride, Tramadol hydrochloride 50 mg/1 tablet, film coated, listed with the FDA by Cranbury Pharmaceuticals, LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Tramadol Hydrochloride.
- What is the active ingredient?
- Tramadol hydrochloride.
- Who is the labeler?
- Cranbury Pharmaceuticals, LLC, NDC labeler code 27808. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Tramadol Hydrochloride?
- 112 other product NDCs are listed under this name. See all Tramadol Hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Tramadol Hydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Tramadol Hydrochloride | Tramadol hydrochloride 50 mg/1 | Tablet, CoatedOral | Unit Dose Solutions, Inc. | 87441-089 | 87441-0089-01 |
| tramadol hydrochloride | Tramadol hydrochloride 25 mg/1 | TabletOral | Strides Pharma Science Limited | 64380-778 | 64380-0778-01 |
| Tramadol Hydrochloride | Tramadol hydrochloride 50 mg/1 | Tablet, CoatedOral | REMEDYREPACK INC. | 70518-4713 | 70518-4713-0070518-4713-0170518-4713-02+1 more |
| tramadol hydrochloride | Tramadol hydrochloride 50 mg/1 | TabletOral | Strides Pharma Science Limited | 64380-791 | 64380-0791-0164380-0791-0264380-0791-03 |
| Tramadol Hydrochloride | Tramadol hydrochloride 50 mg/1 | TabletOral | Advanced Rx of Tennessee, LLC | 80425-0588 | 80425-0588-0180425-0588-0280425-0588-03+5 more |
| Tramadol Hydrochloride | Tramadol hydrochloride 50 mg/1 | Tablet, CoatedOral | Northwind Health Company, LLC | 82868-110 | 82868-0110-30 |
| Tramadol Hydrochloride | Tramadol hydrochloride 50 mg/1 | Tablet, CoatedOral | Coupler LLC | 67046-1209 | 67046-1209-03 |
| Tramadol Hydrochloride | Tramadol hydrochloride 50 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-4114 | 68788-4114-0168788-4114-0268788-4114-03+5 more |
| Tramadol Hydrochloride | Tramadol hydrochloride 50 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | 60760-727 | 60760-0727-0960760-0727-2060760-0727-30+5 more |
| Tramadol Hydrochloride | Tramadol hydrochloride 50 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-4040 | 68788-4040-0168788-4040-0268788-4040-03+6 more |