NDC codes

FDA NDC Directory
Product NDC (as listed)71335-9658Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71335-9658Add 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
71335-9658-0713359658007133596580050 TABLET, COATED in 1 BOTTLE (71335-9658-0)Marketed from Apr 13, 2026
71335-9658-1713359658017133596580130 TABLET, COATED in 1 BOTTLE (71335-9658-1)Marketed from Jun 24, 2025
71335-9658-2713359658027133596580220 TABLET, COATED in 1 BOTTLE (71335-9658-2)Marketed from Jul 2, 2025
71335-9658-3713359658037133596580390 TABLET, COATED in 1 BOTTLE (71335-9658-3)Marketed from Jul 29, 2025
71335-9658-4713359658047133596580460 TABLET, COATED in 1 BOTTLE (71335-9658-4)Marketed from Apr 13, 2026
71335-9658-57133596580571335965805120 TABLET, COATED in 1 BOTTLE (71335-9658-5)Marketed from Jul 15, 2025
71335-9658-67133596580671335965806180 TABLET, COATED in 1 BOTTLE (71335-9658-6)Marketed from Apr 13, 2026
71335-9658-7713359658077133596580740 TABLET, COATED in 1 BOTTLE (71335-9658-7)Marketed from Apr 13, 2026
71335-9658-87133596580871335965808100 TABLET, COATED in 1 BOTTLE (71335-9658-8)Marketed from Dec 24, 2025
71335-9658-9713359658097133596580915 TABLET, COATED in 1 BOTTLE (71335-9658-9)Marketed from Apr 13, 2026

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 — 50 mg/1
Dosage form
Tablet, Coated
Route
Oral
Labeler
Bryant Ranch PrepackNDC labeler code 71335
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 71335-9658_7153f206-8ea3-4cc7-9ce3-733bc1712d2fSPL ID 7153f206-8ea3-4cc7-9ce3-733bc1712d2fSPL set ID 674803a0-4cf5-4416-a5e3-c1a1e332cdcdRxCUI 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

N471335965800 followed by a unit qualifier and the quantity

Package 71335-9658-00. 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

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, misuse, overdose, and death, which can occur at any dosage or duration, and persist over the course of therapy [see Warnings and Precautions (5.1) ] reserve opioid analgesics, including tramadol hydrochloride tablets for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. Tramadol hydrochloride is an opioid agonist indicated in adults for the…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71335-9658

What is NDC 71335-9658?
71335-9658 is the product NDC for Tramadol Hydrochloride, Tramadol hydrochloride 50 mg/1 tablet, coated, listed with the FDA by Bryant Ranch Prepack. It has 10 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?
Bryant Ranch Prepack, NDC labeler code 71335. 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, CoatedOralProficient Rx LP82804-142
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

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