What is NDC 70954-801?

70954-801 is the product NDC for Tapentadol Hydrochloride, Tapentadol hydrochloride 20 mg/mL solution, listed with the FDA by ANI Pharmaceuticals, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.

ANI Pharmaceuticals, Inc., NDC labeler code 70954. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Tapentadol Hydrochloride?

9 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Tapentadol Hydrochloride NDC 70954-801

NDC codes

FDA NDC Directory

Product NDC (as listed)70954-801Labeler and product segments. Claims need a package NDC.

Product NDC at billing width70954-0801Add 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	Copy
70954-801-10	7095408011070954080110	1 BOTTLE in 1 CARTON (70954-801-10) / 100 mL in 1 BOTTLEMarketed from Jul 13, 2026
70954-801-20	7095408012070954080120	1 BOTTLE in 1 CARTON (70954-801-20) / 200 mL in 1 BOTTLEMarketed from Jul 13, 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): Tapentadol Hydrochloride
Generic name (nonproprietary): tapentadol hydrochloride
Active ingredients: Tapentadol hydrochloride — 20 mg/mL
Dosage form: Solution
Route: Oral
Labeler: ANI Pharmaceuticals, Inc.NDC labeler code 70954
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 219119
Marketing start: Jul 13, 2026
Listing expires: Dec 31, 2027
DEA schedule: CII
Other FDA classes: Opioid Agonists (Mechanism)
Identifiers: Product ID 70954-801_38c1235a-d675-4b2d-b1a5-100427af2364SPL ID 38c1235a-d675-4b2d-b1a5-100427af2364SPL set ID e0ecb809-6a55-4afe-b981-b8f174e5c344RxCUI 1356315UNII 71204KII53UPC 0370954801108, 0370954801207
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

N470954080110 followed by a unit qualifier and the quantity

Package 70954-0801-10. 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 Jul 27, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

Tapentadol hydrochloride oral solution is indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate in adults. 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 (5.2)] , reserve opioid analgesics, including tapentadol hydrochloride oral solution for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. Pediatric use information is approved for Collegium Ph…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 70954-801

What is NDC 70954-801?: 70954-801 is the product NDC for Tapentadol Hydrochloride, Tapentadol hydrochloride 20 mg/mL solution, listed with the FDA by ANI Pharmaceuticals, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Tapentadol Hydrochloride.
What is the active ingredient?: Tapentadol hydrochloride.
Who is the labeler?: ANI Pharmaceuticals, Inc., NDC labeler code 70954. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Tapentadol Hydrochloride?: 9 other product NDCs are listed under this name. See all Tapentadol 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 Tapentadol Hydrochloride NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Tapentadol Hydrochloride	Tapentadol hydrochloride 50 mg/1	Tablet, Film coatedOral	AvKARE	73190-081	73190-0081-01
Tapentadol Hydrochloride	Tapentadol hydrochloride 75 mg/1	Tablet, Film coatedOral	AvKARE	73190-082	73190-0082-01
Tapentadol Hydrochloride	Tapentadol hydrochloride 100 mg/1	Tablet, Film coatedOral	AvKARE	73190-083	73190-0083-01
Tapentadol Hydrochloride	Tapentadol hydrochloride 50 mg/1	Tablet, Film coatedOral	Novadoz Pharmaceuticals LLC	72205-369	72205-0369-91
Tapentadol Hydrochloride	Tapentadol hydrochloride 75 mg/1	Tablet, Film coatedOral	Novadoz Pharmaceuticals LLC	72205-370	72205-0370-91
Tapentadol Hydrochloride	Tapentadol hydrochloride 100 mg/1	Tablet, Film coatedOral	Novadoz Pharmaceuticals LLC	72205-371	72205-0371-91
Tapentadol Hydrochloride	Tapentadol hydrochloride 50 mg/1	Tablet, Film coatedOral	EPIC PHARMA LLC	42806-626	42806-0626-01
Tapentadol Hydrochloride	Tapentadol hydrochloride 75 mg/1	Tablet, Film coatedOral	EPIC PHARMA LLC	42806-627	42806-0627-01
Tapentadol Hydrochloride	Tapentadol hydrochloride 100 mg/1	Tablet, Film coatedOral	EPIC PHARMA LLC	42806-628	42806-0628-01