What is NDC 64380-791?

64380-791 is the product NDC for tramadol hydrochloride, Tramadol hydrochloride 50 mg/1 tablet, listed with the FDA by Strides Pharma Science Limited. It has 3 package NDCs, shown above in 10- and 11-digit form.

Strides Pharma Science Limited, NDC labeler code 64380. 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 64380-791

NDC codes

FDA NDC Directory

Product NDC (as listed)64380-791Labeler and product segments. Claims need a package NDC.

Product NDC at billing width64380-0791Add 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
64380-791-01	6438007910164380079101	100 TABLET in 1 BOTTLE (64380-791-01)Marketed from Jul 27, 2026
64380-791-02	6438007910264380079102	500 TABLET in 1 BOTTLE (64380-791-02)Marketed from Jul 27, 2026
64380-791-03	6438007910364380079103	1000 TABLET in 1 BOTTLE (64380-791-03)Marketed from Jul 27, 2026

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
Route: Oral
Labeler: Strides Pharma Science LimitedNDC labeler code 64380
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 202075
Marketing start: Jul 27, 2026
Listing expires: Dec 31, 2027
DEA schedule: CIV
Other FDA classes: Full Opioid Agonists (Mechanism)
Identifiers: Product ID 64380-791_34384cff-f142-46cc-b5cb-ddc8b0f83f0eSPL ID 34384cff-f142-46cc-b5cb-ddc8b0f83f0eSPL set ID a6cbd5de-8ae5-49e3-b89b-e35536b115d8RxCUI 835603, 2670390UNII 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

N464380079101 followed by a unit qualifier and the quantity

Package 64380-0791-01. 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 Aug 27, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

Tramadol hydrochloride tablets 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 with opioids, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions (5.2)] , 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 tablets are an opioid agonist indicated in…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 64380-791

What is NDC 64380-791?: 64380-791 is the product NDC for tramadol hydrochloride, Tramadol hydrochloride 50 mg/1 tablet, listed with the FDA by Strides Pharma Science Limited. It has 3 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?: Strides Pharma Science Limited, NDC labeler code 64380. 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	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
Tramadol Hydrochloride	Tramadol hydrochloride 50 mg/1	TabletOral	St. Mary's Medical Park Pharmacy	60760-727	60760-0727-0960760-0727-2060760-0727-30+5 more

All 113 tramadol hydrochloride NDCs

Other NDCs under ANDA 202075

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

FDA NDC Directory listings under ANDA 202075
Product	Strength	Form · route	Labeler	Product NDC
tramadol hydrochloride	Tramadol hydrochloride 25 mg/1	TabletOral	Strides Pharma Science Limited	64380-778
tramadol hydrochloride	Tramadol hydrochloride 50 mg/1	TabletOral	NuCare Pharmaceuticals, Inc.	68071-3644
tramadol hydrochloride	Tramadol hydrochloride 50 mg/1	TabletOral	NuCare Pharmaceuticals,Inc.	68071-3655
tramadol hydrochloride	Tramadol hydrochloride 50 mg/1	TabletOral	Preferred Pharmaceuticals Inc.	68788-8717
tramadol hydrochloride	Tramadol hydrochloride 50 mg/1	TabletOral	REMEDYREPACK INC.	70518-4248
tramadol hydrochloride	Tramadol hydrochloride 50 mg/1	TabletOral	Bryant Ranch Prepack	71335-2518
tramadol hydrochloride	Tramadol hydrochloride 50 mg/1	TabletOral	Bryant Ranch Prepack	71335-2612
tramadol hydrochloride	Tramadol hydrochloride 50 mg/1	TabletOral	Proficient Rx LP	82804-114
tramadol hydrochloride	Tramadol hydrochloride 50 mg/1	TabletOral	Northwind Health Company, LLC	82868-052