What is NDC 47335-859?

47335-859 is the product NDC for Tramadol Hydrochloride, Tramadol hydrochloride 100 mg/1 tablet, extended release, listed with the FDA by Sun Pharmaceutical Industries, Inc.. It has 4 package NDCs, shown above in 10- and 11-digit form.

Sun Pharmaceutical Industries, Inc., NDC labeler code 47335. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Tramadol Hydrochloride NDC 47335-859

NDC codes

FDA NDC Directory

Product NDC (as listed)47335-859Labeler and product segments. Claims need a package NDC.

Product NDC at billing width47335-0859Add 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 NDC	11-digit (billing)	Package
47335-859-08	4733508590847335085908	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (47335-859-08)Marketed from Dec 12, 2011
47335-859-18	4733508591847335085918	1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (47335-859-18)Marketed from Dec 12, 2011
47335-859-83	4733508598347335085983	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (47335-859-83)Marketed from Dec 12, 2011
47335-859-88	4733508598847335085988	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (47335-859-88)Marketed from Dec 12, 2011

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 — 100 mg/1
Dosage form: Tablet, Extended release
Route: Oral
Labeler: Sun Pharmaceutical Industries, Inc.NDC labeler code 47335
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 201384
Marketing start: Dec 12, 2011
Listing expires: Dec 31, 2026
DEA schedule: CIV
Other FDA classes: Full Opioid Agonists (Mechanism)
Identifiers: Product ID 47335-859_a994e116-d201-47f9-baaf-dd76a84eba7eSPL ID a994e116-d201-47f9-baaf-dd76a84eba7eSPL set ID 004de5a4-80f8-4040-a6ea-be5e99352a36RxCUI 833709, 833711, 833713UNII 9N7R477WCKUPC 0347335861839, 0347335860832, 0347335859836
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

N447335085908 followed by a unit qualifier and the quantity

Package 47335-0859-08. 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 Nov 20, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

Tramadol hydrochloride extended-release tablets are indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. Limitations of Use • Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosages or duration, and persist over the course of therapy, [see Warnings and Precautions (5.1)], reserve opioid analgesics, including tramadol hydrochloride extended-release tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated or would be otherwise inadequate to provide sufficient managemen…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 47335-859

What is NDC 47335-859?: 47335-859 is the product NDC for Tramadol Hydrochloride, Tramadol hydrochloride 100 mg/1 tablet, extended release, listed with the FDA by Sun Pharmaceutical Industries, Inc.. It has 4 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?: Sun Pharmaceutical Industries, Inc., NDC labeler code 47335. 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
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Tramadol Hydrochloride	Tramadol hydrochloride 50 mg/1	TabletOral	REMEDYREPACK INC.	70518-4790	70518-4790-00
Tramadol Hydrochloride	Tramadol hydrochloride 25 mg/1	TabletOral	Rising Pharma Holdings, Inc.	64980-717	64980-0717-03
Tramadol Hydrochloride	Tramadol hydrochloride 50 mg/1	Tablet, CoatedOral	Unit Dose Solutions, Inc.	87441-089	87441-0089-01
tramadol hydrochloride	Tramadol hydrochloride 25 mg/1	TabletOral	Strides Pharma Science Limited	64380-778	64380-0778-01
Tramadol Hydrochloride	Tramadol hydrochloride 50 mg/1	Tablet, CoatedOral	REMEDYREPACK INC.	70518-4713	70518-4713-0070518-4713-0170518-4713-02+1 more
tramadol hydrochloride	Tramadol hydrochloride 50 mg/1	TabletOral	Strides Pharma Science Limited	64380-791	64380-0791-0164380-0791-0264380-0791-03
Tramadol Hydrochloride	Tramadol hydrochloride 50 mg/1	TabletOral	Advanced Rx of Tennessee, LLC	80425-0588	80425-0588-0180425-0588-0280425-0588-03+5 more
Tramadol Hydrochloride	Tramadol hydrochloride 50 mg/1	Tablet, CoatedOral	Northwind Health Company, LLC	82868-110	82868-0110-30
Tramadol Hydrochloride	Tramadol hydrochloride 50 mg/1	Tablet, CoatedOral	Coupler LLC	67046-1209	67046-1209-03
Tramadol Hydrochloride	Tramadol hydrochloride 50 mg/1	TabletOral	Preferred Pharmaceuticals Inc.	68788-4114	68788-4114-0168788-4114-0268788-4114-03+5 more

All 113 Tramadol Hydrochloride NDCs

Other NDCs under ANDA 201384

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

FDA NDC Directory listings under ANDA 201384
Product	Strength	Form · route	Labeler	Product NDC
Tramadol HCL ERtramadol hcl	Tramadol hydrochloride 100 mg/1	Tablet, Extended releaseOral	Advanced Rx Pharmacy of Tennessee, LLC	80425-0141
Tramadol Hydrochloride	Tramadol hydrochloride 200 mg/1	Tablet, Extended releaseOral	Sun Pharmaceutical Industries, Inc.	47335-860
Tramadol Hydrochloride	Tramadol hydrochloride 300 mg/1	Tablet, Extended releaseOral	Sun Pharmaceutical Industries, Inc.	47335-861
Tramadol Hydrochloride	Tramadol hydrochloride 200 mg/1	Tablet, Extended releaseOral	DIRECT RX	61919-893
Tramadol Hydrochloride	Tramadol hydrochloride 100 mg/1	Tablet, Extended releaseOral	Proficient Rx LP	63187-597
Tramadol Hydrochloride	Tramadol hydrochloride 300 mg/1	Tablet, Extended releaseOral	Bryant Ranch Prepack	63629-8324
Tramadol Hydrochloride	Tramadol hydrochloride 300 mg/1	Tablet, Extended releaseOral	Proficient Rx LP	71205-656
Tramadol Hydrochloride	Tramadol hydrochloride 200 mg/1	Tablet, Extended releaseOral	Proficient Rx LP	71205-708
Tramadol Hydrochloride	Tramadol hydrochloride 100 mg/1	Tablet, Extended releaseOral	Bryant Ranch Prepack	71335-1675
Tramadol Hydrochloride	Tramadol hydrochloride 200 mg/1	Tablet, Extended releaseOral	Bryant Ranch Prepack	71335-1676
Tramadol Hydrochloride	Tramadol hydrochloride 100 mg/1	Tablet, Extended releaseOral	Asclemed USA, Inc.	76420-244
Tramadol Hydrochloride	Tramadol hydrochloride 200 mg/1	Tablet, Extended releaseOral	Asclemed USA, Inc.	76420-245
Tramadol Hydrochloride	Tramadol hydrochloride 300 mg/1	Tablet, Extended releaseOral	Asclemed USA, Inc.	76420-246