Prescription drug · ANDA

Tramadol Hydrochloride NDC 70518-0942

Tramadol hydrochloride 100 mg/1 · Tablet, Extended release · Oral · REMEDYREPACK INC.

NDC codes

FDA NDC Directory
Product NDC (as listed)70518-0942Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70518-0942Add 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
70518-0942-07051809420030 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70518-0942-0)Marketed from Jan 9, 2018
70518-0942-27051809420260 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70518-0942-2)Marketed from Jul 10, 2024

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 Hydrochloride
Generic name (nonproprietary)
tramadol hydrochloride
Active ingredients
Tramadol hydrochloride — 100 mg/1
Dosage form
Tablet, Extended release
Route
Oral
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 70518-0942_559f3565-a8d0-eae2-e063-6394a90ab34eSPL ID 559f3565-a8d0-eae2-e063-6394a90ab34eSPL set ID 16053b28-c759-4914-93e6-2de0afe72445RxCUI 833709UNII 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

N470518094200 followed by a unit qualifier and the quantity

Package 70518-0942-00. 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

Label details couldn’t be retrieved right now. Open the label on DailyMed.

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 300 mg/1Tablet, Extended releaseOralNuCare Pharmaceuticals,Inc.68071-5078
Tramadol HydrochlorideTramadol hydrochloride 300 mg/1Tablet, Extended releaseOralMedsource Pharmaceuticals45865-184
Tramadol HydrochlorideTramadol hydrochloride 200 mg/1Tablet, Extended releaseOralREMEDYREPACK INC.70518-0886
Tramadol HydrochlorideTramadol hydrochloride 100 mg/1Tablet, Extended releaseOralLupin Pharmaceuticals, Inc.68180-697
Tramadol HydrochlorideTramadol hydrochloride 200 mg/1Tablet, Extended releaseOralDIRECT RX72189-154
Tramadol HydrochlorideTramadol hydrochloride 200 mg/1Tablet, Extended releaseOralLupin Pharmaceuticals, Inc.68180-698
Tramadol HydrochlorideTramadol hydrochloride 100 mg/1Tablet, Extended releaseOralCoupler LLC67046-1527
Tramadol HydrochlorideTramadol hydrochloride 300 mg/1Tablet, Extended releaseOralLupin Pharmaceuticals, Inc.68180-699
Tramadol HydrochlorideTramadol hydrochloride 200 mg/1Tablet, Extended releaseOralPreferred Pharmaceuticals, Inc.68788-7601
Tramadol HCL ERTramadol hydrochloride 300 mg/1Tablet, Extended releaseOralDirect_Rx72189-521
Tramadol HydrochlorideTramadol hydrochloride 100 mg/1Tablet, Extended releaseOralProficient Rx LP71205-463
Tramadol HCL ERtramadol hclTramadol hydrochloride 300 mg/1Tablet, Extended releaseOralAdvanced Rx Pharmacy of Tennessee, LLC80425-0312
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
Tramadol HydrochlorideTramadol hydrochloride 200 mg/1Tablet, Extended releaseOralQuality Care Products, LLC83008-009
Tramadol HydrochlorideTramadol hydrochloride 100 mg/1Tablet, Extended releaseOralPreferred Pharmaceuticals, Inc.68788-8367
Tramadol HydrochlorideTramadol hydrochloride 200 mg/1Tablet, Extended releaseOralAsclemed USA, Inc.76420-537
Tramadol HydrochlorideTramadol hydrochloride 100 mg/1Tablet, Extended releaseOralAsclemed USA, Inc.76420-536
Tramadol HydrochlorideTramadol hydrochloride 100 mg/1Tablet, Extended releaseOralLupin Pharmaceuticals, Inc.68180-383

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