Prescription drug · ANDA

Tramadol HCL ER (Tramadol hcl) NDC 80425-0136

Tramadol hydrochloride 200 mg/1 · Tablet, Extended release · Oral · Advanced Rx Pharmacy of Tennessee, LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)80425-0136Labeler and product segments. Claims need a package NDC.
Product NDC at billing width80425-0136Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
80425-0136-18042501360130 TABLET, EXTENDED RELEASE in 1 BOTTLE (80425-0136-1)Marketed from May 22, 2023
80425-0136-28042501360260 TABLET, EXTENDED RELEASE in 1 BOTTLE (80425-0136-2)Marketed from Aug 19, 2014

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 HCL ERSuffix: ER
Generic name (nonproprietary)
tramadol hcl
Active ingredients
Tramadol hydrochloride — 200 mg/1
Dosage form
Tablet, Extended release
Route
Oral
Labeler
Advanced Rx Pharmacy of Tennessee, LLCNDC labeler code 80425
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 200503
Marketing start
Listing expires
DEA schedule
CIV
Other FDA classes
Full Opioid Agonists (Mechanism)
Identifiers
Product ID 80425-0136_2a99a670-af2c-299d-e063-6294a90a05d2SPL ID 2a99a670-af2c-299d-e063-6294a90a05d2SPL set ID bf51a3af-cbc6-3021-e053-2a95a90a80b7RxCUI 833711UNII 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

N480425013601 followed by a unit qualifier and the quantity

Package 80425-0136-01. 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)

1. Indications and Usage Section 1 INDICATIONS AND USAGE Tramadol hydrochloride extended-release tablets are indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations [see Warnings and Precautions (5.1)] , reserve tramadol hydrochloride extended-release tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opi…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 80425-0136

What is NDC 80425-0136?
80425-0136 is the product NDC for Tramadol HCL ER (tramadol hcl), Tramadol hydrochloride 200 mg/1 tablet, extended release, listed with the FDA by Advanced Rx Pharmacy of Tennessee, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Tramadol HCL ER (Tramadol HCL).
What is the active ingredient?
Tramadol hydrochloride.
Who is the labeler?
Advanced Rx Pharmacy of Tennessee, LLC, NDC labeler code 80425. 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 HCL ER?
6 other product NDCs are listed under this name. See all Tramadol HCL ER NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Tramadol HCL ER NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Tramadol HCL ERTramadol hydrochloride 300 mg/1Tablet, Extended releaseOralDirect_Rx72189-52172189-0521-30
Tramadol HCL ERtramadol hclTramadol hydrochloride 300 mg/1Tablet, Extended releaseOralAdvanced Rx Pharmacy of Tennessee, LLC80425-031280425-0312-0180425-0312-0280425-0312-03
Tramadol HCl ERtramadol hclTramadol hydrochloride 100 mg/1Tablet, Extended releaseOralDIRECT RX61919-81861919-0818-3061919-0818-6061919-0818-90
Tramadol HCL ERtramadol hclTramadol hydrochloride 100 mg/1Tablet, Extended releaseOralAdvanced Rx Pharmacy of Tennessee, LLC80425-010880425-0108-0180425-0108-0280425-0108-03
Tramadol HCL ERtramadol hclTramadol hydrochloride 200 mg/1Tablet, Extended releaseOralAdvanced Rx Pharmacy of Tennessee, LLC80425-012780425-0127-0180425-0127-02
Tramadol HCL ERtramadol hclTramadol hydrochloride 100 mg/1Tablet, Extended releaseOralAdvanced Rx Pharmacy of Tennessee, LLC80425-014180425-0141-0180425-0141-0280425-0141-03

Other NDCs under ANDA 200503

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 200503
ProductStrengthForm · routeLabelerProduct NDC
Tramadol HydrochlorideTramadol hydrochloride 100 mg/1Tablet, Extended releaseOralBryant Ranch Prepack63629-8323
Tramadol HydrochlorideTramadol hydrochloride 200 mg/1Tablet, Extended releaseOralBryant Ranch Prepack63629-8319
Tramadol HydrochlorideTramadol hydrochloride 300 mg/1Tablet, Extended releaseOralProficient Rx LP71205-569
Tramadol HydrochlorideTramadol hydrochloride 100 mg/1Tablet, Extended releaseOralQuality Care Products, LLC55700-996
Tramadol HydrochlorideTramadol hydrochloride 300 mg/1Tablet, Extended releaseOralNuCare Pharmaceuticals,Inc.68071-5078
Tramadol HydrochlorideTramadol hydrochloride 200 mg/1Tablet, Extended releaseOralREMEDYREPACK INC.70518-0886
Tramadol HydrochlorideTramadol hydrochloride 100 mg/1Tablet, Extended releaseOralREMEDYREPACK INC.70518-0942
Tramadol HydrochlorideTramadol hydrochloride 300 mg/1Tablet, Extended releaseOralMedsource Pharmaceuticals45865-184
Tramadol HydrochlorideTramadol hydrochloride 300 mg/1Tablet, Extended releaseOralLupin Pharmaceuticals, Inc.68180-699
Tramadol HydrochlorideTramadol hydrochloride 100 mg/1Tablet, Extended releaseOralLupin Pharmaceuticals, Inc.68180-697
Tramadol HydrochlorideTramadol hydrochloride 200 mg/1Tablet, Extended releaseOralLupin Pharmaceuticals, Inc.68180-698
Tramadol HydrochlorideTramadol hydrochloride 200 mg/1Tablet, Extended releaseOralDIRECT RX72189-154
Tramadol HydrochlorideTramadol hydrochloride 100 mg/1Tablet, Extended releaseOralCoupler LLC67046-1527
Tramadol HCL ERtramadol hclTramadol hydrochloride 300 mg/1Tablet, Extended releaseOralAdvanced Rx Pharmacy of Tennessee, LLC80425-0312
Tramadol HydrochlorideTramadol hydrochloride 200 mg/1Tablet, Extended releaseOralPreferred Pharmaceuticals, Inc.68788-7601
Tramadol HydrochlorideTramadol hydrochloride 100 mg/1Tablet, Extended releaseOralProficient Rx LP71205-463
Tramadol HCL ERTramadol hydrochloride 300 mg/1Tablet, Extended releaseOralDirect_Rx72189-521
Tramadol HydrochlorideTramadol hydrochloride 200 mg/1Tablet, Extended releaseOralProficient Rx LP71205-468
Tramadol HCl ERtramadol hclTramadol hydrochloride 100 mg/1Tablet, Extended releaseOralDIRECT RX61919-818
Tramadol HydrochlorideTramadol hydrochloride 300 mg/1Tablet, Extended releaseOralBryant Ranch Prepack71335-9670

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