NDC codes

FDA NDC Directory
Product NDC (as listed)82804-142Labeler and product segments. Claims need a package NDC.
Product NDC at billing width82804-0142Add 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
82804-142-15828040142158280401421515 TABLET, COATED in 1 BOTTLE (82804-142-15)Marketed from Oct 21, 2024
82804-142-20828040142208280401422020 TABLET, COATED in 1 BOTTLE (82804-142-20)Marketed from Sep 19, 2024
82804-142-30828040142308280401423030 TABLET, COATED in 1 BOTTLE (82804-142-30)Marketed from Sep 19, 2024
82804-142-60828040142608280401426060 TABLET, COATED in 1 BOTTLE (82804-142-60)Marketed from Sep 19, 2024
82804-142-728280401427282804014272120 TABLET, COATED in 1 BOTTLE (82804-142-72)Marketed from Nov 5, 2024
82804-142-788280401427882804014278180 TABLET, COATED in 1 BOTTLE (82804-142-78)Marketed from Jan 15, 2025
82804-142-90828040142908280401429090 TABLET, COATED in 1 BOTTLE (82804-142-90)Marketed from Sep 19, 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, Coated
Route
Oral
Labeler
Proficient Rx LPNDC labeler code 82804
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 82804-142_e878d5e0-2cab-4e0a-9a85-22b34420dcf6SPL ID e878d5e0-2cab-4e0a-9a85-22b34420dcf6SPL set ID d7e75fd3-18d1-4370-bb63-c9dd8a2c1719RxCUI 835603UNII 9N7R477WCKUPC 0382804142606
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

N482804014215 followed by a unit qualifier and the quantity

Package 82804-0142-15. 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, which can occur at any dosage or duration [see Error! Hyperlink reference not valid. ] , 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 tabl…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 82804-142

What is NDC 82804-142?
82804-142 is the product NDC for Tramadol Hydrochloride, Tramadol hydrochloride 50 mg/1 tablet, coated, listed with the FDA by Proficient Rx LP. It has 7 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?
Proficient Rx LP, NDC labeler code 82804. 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.

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

Other Tramadol Hydrochloride NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Tramadol HydrochlorideTramadol hydrochloride 50 mg/1TabletOralREMEDYREPACK INC.70518-479070518-4790-00
Tramadol HydrochlorideTramadol hydrochloride 25 mg/1TabletOralRising Pharma Holdings, Inc.64980-71764980-0717-03
Tramadol HydrochlorideTramadol hydrochloride 50 mg/1Tablet, CoatedOralUnit Dose Solutions, Inc.87441-08987441-0089-01
tramadol hydrochlorideTramadol hydrochloride 25 mg/1TabletOralStrides Pharma Science Limited64380-77864380-0778-01
Tramadol HydrochlorideTramadol hydrochloride 50 mg/1Tablet, CoatedOralREMEDYREPACK INC.70518-471370518-4713-0070518-4713-0170518-4713-02+1 more
tramadol hydrochlorideTramadol hydrochloride 50 mg/1TabletOralStrides Pharma Science Limited64380-79164380-0791-0164380-0791-0264380-0791-03
Tramadol HydrochlorideTramadol hydrochloride 50 mg/1TabletOralAdvanced Rx of Tennessee, LLC80425-058880425-0588-0180425-0588-0280425-0588-03+5 more
Tramadol HydrochlorideTramadol hydrochloride 50 mg/1Tablet, CoatedOralNorthwind Health Company, LLC82868-11082868-0110-30
Tramadol HydrochlorideTramadol hydrochloride 50 mg/1Tablet, CoatedOralCoupler LLC67046-120967046-1209-03
Tramadol HydrochlorideTramadol hydrochloride 50 mg/1TabletOralPreferred Pharmaceuticals Inc.68788-411468788-4114-0168788-4114-0268788-4114-03+5 more

All 113 Tramadol Hydrochloride NDCs

Other NDCs under ANDA 208708

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

FDA NDC Directory listings under ANDA 208708
ProductStrengthForm · routeLabelerProduct NDC
Tramadol HydrochlorideTramadol hydrochloride 50 mg/1Tablet, CoatedOralQuality Care Products, LLC55700-997
Tramadol HydrochlorideTramadol hydrochloride 50 mg/1Tablet, CoatedOralNorthwind Health Company, LLC82868-110
Tramadol HydrochlorideTramadol hydrochloride 50 mg/1Tablet, CoatedOralDirectRx72189-311
Tramadol HydrochlorideTramadol hydrochloride 50 mg/1Tablet, CoatedOralPreferred Pharmaceuticals Inc.68788-8121
Tramadol HydrochlorideTramadol hydrochloride 25 mg/1Tablet, CoatedOralAdvagen Pharma Limited72888-162
Tramadol HydrochlorideTramadol hydrochloride 50 mg/1Tablet, CoatedOralREMEDYREPACK INC.70518-3824
Tramadol HydrochlorideTramadol hydrochloride 75 mg/1Tablet, CoatedOralAdvagen Pharma Limited72888-163
Tramadol HydrochlorideTramadol hydrochloride 100 mg/1Tablet, CoatedOralAsclemed USA, Inc.76420-734
Tramadol HydrochlorideTramadol hydrochloride 100 mg/1Tablet, CoatedOralCoupler LLC67046-1541
Tramadol HydrochlorideTramadol hydrochloride 25 mg/1Tablet, CoatedOralAsclemed USA, Inc.76420-732
Tramadol HydrochlorideTramadol hydrochloride 50 mg/1Tablet, CoatedOralAsclemed USA, Inc.76420-733
Tramadol HydrochlorideTramadol hydrochloride 50 mg/1Tablet, CoatedOralTRUPHARMA LLC52817-195
Tramadol HydrochlorideTramadol hydrochloride 50 mg/1Tablet, CoatedOralAdvanced Rx Pharmacy of Tennessee, LLC80425-0276
Tramadol HydrochlorideTramadol hydrochloride 100 mg/1Tablet, CoatedOralTRUPHARMA LLC52817-196
Tramadol HydrochlorideTramadol hydrochloride 50 mg/1Tablet, CoatedOralAdvanced Rx Pharmacy of Tennessee, LLC80425-0274
Tramadol HydrochlorideTramadol hydrochloride 50 mg/1Tablet, CoatedOralREMEDYREPACK INC.70518-4713
Tramadol HydrochlorideTramadol hydrochloride 100 mg/1Tablet, CoatedOralAdvagen Pharma Limited72888-008
Tramadol HydrochlorideTramadol hydrochloride 50 mg/1Tablet, CoatedOralBryant Ranch Prepack71335-2721
Tramadol HydrochlorideTramadol hydrochloride 50 mg/1Tablet, CoatedOralRedPharm Drug Inc67296-1834
Tramadol HydrochlorideTramadol hydrochloride 50 mg/1Tablet, CoatedOralBryant Ranch Prepack71335-9658

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