Prescription drug · ANDA

Tramadol HCl ER (Tramadol hcl) NDC 61919-818

Tramadol hydrochloride 100 mg/1 · Tablet, Extended release · Oral · DIRECT RX

NDC codes

FDA NDC Directory
Product NDC (as listed)61919-818Labeler and product segments. Claims need a package NDC.
Product NDC at billing width61919-0818Add 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
61919-818-30619190818306191908183030 TABLET, EXTENDED RELEASE in 1 BOTTLE (61919-818-30)Marketed from May 3, 2019
61919-818-60619190818606191908186060 TABLET, EXTENDED RELEASE in 1 BOTTLE (61919-818-60)Marketed from May 3, 2019
61919-818-90619190818906191908189090 TABLET, EXTENDED RELEASE in 1 BOTTLE (61919-818-90)Marketed from May 3, 2019

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 HCl ERSuffix: ER
Generic name (nonproprietary)
tramadol hcl
Active ingredients
Tramadol hydrochloride — 100 mg/1
Dosage form
Tablet, Extended release
Route
Oral
Labeler
DIRECT RXNDC labeler code 61919
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 61919-818_24ac4469-6ec1-7d80-e063-6394a90aacf5SPL ID 24ac4469-6ec1-7d80-e063-6394a90aacf5SPL set ID 5285f056-c32c-4e7a-bec6-3a726aa23d5aRxCUI 833709, 833711, 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

N461919081830 followed by a unit qualifier and the quantity

Package 61919-0818-30. 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)

INDICATIONS & USAGE SECTION Tramadol hydrochloride extended-release tablets are indicated for the management of moderate to moderately severe chronic pain in adults who require around-the-clock treatment of their pain for an extended period of time

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 61919-818

What is NDC 61919-818?
61919-818 is the product NDC for Tramadol HCl ER (tramadol hcl), Tramadol hydrochloride 100 mg/1 tablet, extended release, listed with the FDA by DIRECT RX. It has 3 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?
DIRECT RX, NDC labeler code 61919. 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 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, LLC80425-013680425-0136-0180425-0136-02
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 HCL ERTramadol hydrochloride 300 mg/1Tablet, Extended releaseOralDirect_Rx72189-521
Tramadol HCL ERtramadol hclTramadol hydrochloride 100 mg/1Tablet, Extended releaseOralAdvanced Rx Pharmacy of Tennessee, LLC80425-0108
Tramadol HCL ERtramadol hclTramadol hydrochloride 200 mg/1Tablet, Extended releaseOralAdvanced Rx Pharmacy of Tennessee, LLC80425-0136
Tramadol HCL ERtramadol hclTramadol hydrochloride 300 mg/1Tablet, Extended releaseOralAdvanced Rx Pharmacy of Tennessee, LLC80425-0312
Tramadol HydrochlorideTramadol hydrochloride 300 mg/1Tablet, Extended releaseOralMedsource Pharmaceuticals45865-184
Tramadol HydrochlorideTramadol hydrochloride 100 mg/1Tablet, Extended releaseOralA-S Medication Solutions50090-5107
Tramadol HydrochlorideTramadol hydrochloride 100 mg/1Tablet, Extended releaseOralQuality Care Products, LLC55700-996
Tramadol HydrochlorideTramadol hydrochloride 200 mg/1Tablet, Extended releaseOralBryant Ranch Prepack63629-8319
Tramadol HydrochlorideTramadol hydrochloride 100 mg/1Tablet, Extended releaseOralBryant Ranch Prepack63629-8323
Tramadol HydrochlorideTramadol hydrochloride 100 mg/1Tablet, Extended releaseOralCoupler LLC67046-1527
Tramadol HydrochlorideTramadol hydrochloride 100 mg/1Tablet, Extended releaseOralNuCare Pharmaceuticals,Inc.68071-1671
Tramadol HydrochlorideTramadol hydrochloride 300 mg/1Tablet, Extended releaseOralNuCare Pharmaceuticals,Inc.68071-5078
Tramadol HydrochlorideTramadol hydrochloride 100 mg/1Tablet, Extended releaseOralLupin Pharmaceuticals, Inc.68180-383
Tramadol HydrochlorideTramadol hydrochloride 200 mg/1Tablet, Extended releaseOralLupin Pharmaceuticals, Inc.68180-384
Tramadol HydrochlorideTramadol hydrochloride 300 mg/1Tablet, Extended releaseOralLupin Pharmaceuticals, Inc.68180-385
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 300 mg/1Tablet, Extended releaseOralLupin Pharmaceuticals, Inc.68180-699
Tramadol HydrochlorideTramadol hydrochloride 200 mg/1Tablet, Extended releaseOralPreferred Pharmaceuticals, Inc.68788-7601
Tramadol HydrochlorideTramadol hydrochloride 100 mg/1Tablet, Extended releaseOralPreferred Pharmaceuticals, Inc.68788-8367

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