What is NDC 65145-108?

65145-108 is the product NDC for Ropivacaine Hydrochloride, Ropivacaine hydrochloride 5 mg/mL injection, listed with the FDA by Caplin Steriles Limited. It has 1 package NDC, shown above in 10- and 11-digit form.

Caplin Steriles Limited, NDC labeler code 65145. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Ropivacaine Hydrochloride?

65 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Ropivacaine Hydrochloride NDC 65145-108

NDC codes

FDA NDC Directory

Product NDC (as listed)65145-108Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65145-0108Add 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
65145-108-10	6514501081065145010810	10 VIAL in 1 CARTON (65145-108-10) / 20 mL in 1 VIAL (65145-108-01)Marketed from Jun 24, 2025

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): Ropivacaine Hydrochloride
Generic name (nonproprietary): ropivacaine hydrochloride
Active ingredients: Ropivacaine hydrochloride — 5 mg/mL
Dosage form: Injection
Route: Epidural, Infiltration, Perineural
Labeler: Caplin Steriles LimitedNDC labeler code 65145
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 212808
Marketing start: Jun 24, 2025
Listing expires: Dec 31, 2027
Other FDA classes: Amides (Chemical structure)Local Anesthesia (Physiologic effect)
Identifiers: Product ID 65145-108_2d5d4dcd-b082-4bbb-838b-615d0f14bbc5SPL ID 2d5d4dcd-b082-4bbb-838b-615d0f14bbc5SPL set ID a9010ea8-0923-44e4-a7c7-7d65d37d06dbRxCUI 1734084, 1734207, 1734347, 1734355, 1734475, 1734483UNII V910P86109UPC 0365145108104, 0365145108012, 0365145109101, 0365145166012, 0365145107015, 0365145107107, 0365145110015, 0365145165015, 0365145109019, 0365145110107
Pharmacologic class: Amide Local Anesthetic

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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

NDC on a medical claim

N465145010810 followed by a unit qualifier and the quantity

Package 65145-0108-10. 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 Jun 24, 2025.

Indications (excerpt from the label)

Ropivacaine Hydrochloride is indicated for the production of local or regional anesthesia for surgery and for acute pain management. Surgical Anesthesia : epidural block for surgery including cesarean section; major nerve block; local infiltration Acute Pain Management : epidural continuous infusion or intermittent bolus, e.g., postoperative or labor; local infiltration Ropivacaine Hydrochloride injection is an amide local anesthetic indicated in adults for the production of local or regional anesthesia for surgery and for acute pain management. Surgical Anesthesia : epidural block for surgery including caesarean section; major nerve block; local infiltration Acute Pain Management : epidural…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 65145-108

What is NDC 65145-108?: 65145-108 is the product NDC for Ropivacaine Hydrochloride, Ropivacaine hydrochloride 5 mg/mL injection, listed with the FDA by Caplin Steriles Limited. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Ropivacaine Hydrochloride.
What is the active ingredient?: Ropivacaine hydrochloride.
Who is the labeler?: Caplin Steriles Limited, NDC labeler code 65145. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Ropivacaine Hydrochloride?: 65 other product NDCs are listed under this name. See all Ropivacaine 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 Ropivacaine Hydrochloride NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Ropivacaine Hydrochloride	Ropivacaine hydrochloride 150 mg/30mL	InjectionEpidural, Infiltration, Perineural	Armas Pharmaceuticals Inc.	72485-519	72485-0519-10
Ropivacaine Hydrochloride	Ropivacaine hydrochloride 2 mg/mL	InjectionEpidural, Infiltration	Hikma Pharmaceuticals USA Inc.	0143-9263	00143-9263-10
Ropivacaine Hydrochloride	Ropivacaine hydrochloride 5 mg/mL	InjectionEpidural, Infiltration	Hikma Pharmaceuticals USA Inc.	0143-9264	00143-9264-10
Ropivacaine Hydrochloride	Ropivacaine hydrochloride 7.5 mg/mL	InjectionEpidural	Hikma Pharmaceuticals USA Inc.	0143-9265	00143-9265-10
Ropivacaine Hydrochloride	Ropivacaine hydrochloride 10 mg/mL	InjectionEpidural	Hikma Pharmaceuticals USA Inc.	0143-9266	00143-9266-10
Ropivacaine Hydrochloride	Ropivacaine hydrochloride 2 mg/mL	Injection, SolutionEpidural, Infiltration, Perineural	Hikma Pharmaceuticals USA Inc.	0143-9195	00143-9195-24
Ropivacaine Hydrochloride	Ropivacaine hydrochloride 2 mg/mL	Injection, SolutionEpidural, Infiltration, Perineural	Hikma Pharmaceuticals USA Inc.	0143-9196	00143-9196-12
Ropivacaine Hydrochloride	Ropivacaine hydrochloride 5 mg/mL	Injection, SolutionEpidural, Infiltration, Perineural	Hikma Pharmaceuticals USA Inc.	0143-9197	00143-9197-24
Ropivacaine Hydrochloride	Ropivacaine hydrochloride 2 mg/mL	Injection, SolutionEpidural, Infiltration	Glenmark Pharmaceuticals Inc., USA	68462-777	68462-0777-35
Ropivacaine Hydrochloride	Ropivacaine hydrochloride 5 mg/mL	Injection, SolutionEpidural, Infiltration, Perineural	Glenmark Pharmaceuticals Inc., USA	68462-778	68462-0778-5568462-0778-74

All 66 Ropivacaine Hydrochloride NDCs

Other NDCs under ANDA 212808

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

FDA NDC Directory listings under ANDA 212808
Product	Strength	Form · route	Labeler	Product NDC
Ropivacaine Hydrochloride	Ropivacaine hydrochloride 10 mg/mL	InjectionEpidural, Infiltration, Perineural	Baxter Healthcare Corporation	43066-027
Ropivacaine Hydrochloride	Ropivacaine hydrochloride 5 mg/mL	InjectionEpidural, Infiltration, Perineural	Baxter Healthcare Corporation	43066-023
Ropivacaine Hydrochloride	Ropivacaine hydrochloride 2 mg/mL	InjectionEpidural, Infiltration, Perineural	Baxter Healthcare Corporation	43066-015
Ropivacaine Hydrochloride	Ropivacaine hydrochloride 5 mg/mL	InjectionEpidural, Infiltration, Perineural	Baxter Healthcare Corporation	43066-019
Ropivacaine Hydrochloride	Ropivacaine hydrochloride 150 mg/30mL	InjectionEpidural, Infiltration, Perineural	Armas Pharmaceuticals Inc.	72485-519
Ropivacaine Hydrochloride	Ropivacaine hydrochloride 5 mg/mL	InjectionEpidural, Infiltration, Perineural	Civica, Inc.	72572-707
Ropivacaine Hydrochloride	Ropivacaine hydrochloride 2 mg/mL	InjectionEpidural, Infiltration	Caplin Steriles Limited	65145-165
Ropivacaine Hydrochloride	Ropivacaine hydrochloride 2 mg/mL	InjectionEpidural, Infiltration	Caplin Steriles Limited	65145-166
Ropivacaine Hydrochloride	Ropivacaine hydrochloride 10 mg/mL	InjectionEpidural	Caplin Steriles Limited	65145-110
Ropivacaine Hydrochloride	Ropivacaine hydrochloride 2 mg/mL	InjectionEpidural, Infiltration, Perineural	Caplin Steriles Limited	65145-107
Ropivacaine Hydrochloride	Ropivacaine hydrochloride 5 mg/mL	InjectionEpidural, Infiltration, Perineural	Caplin Steriles Limited	65145-109
Ropivacaine Hydrochloride	Ropivacaine hydrochloride 2 mg/mL	Injection, SolutionEpidural, Infiltration, Perineural	SOLA Pharmaceuticals, LLC	70512-798
Ropivacaine Hydrochloride	Ropivacaine hydrochloride 2 mg/mL	Injection, SolutionEpidural, Infiltration, Perineural	SOLA Pharmaceuticals, LLC	70512-797
Ropivacaine Hydrochloride	Ropivacaine hydrochloride 2 mg/mL	Injection, SolutionEpidural, Infiltration, Perineural	FRESENIUS KABI USA, LLC	65219-632