NDC codes

FDA NDC Directory
Product NDC (as listed)67457-798Labeler and product segments. Claims need a package NDC.
Product NDC at billing width67457-0798Add 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
67457-798-99674570798996745707989910 POUCH in 1 CARTON (67457-798-99) / 1 BAG in 1 POUCH (67457-798-10) / 100 mL in 1 BAGMarketed from Mar 18, 2024

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 — 2 mg/mL
Dosage form
Injection, Solution
Route
Epidural, Infiltration, Perineural
Labeler
Mylan Institutional LLCNDC labeler code 67457
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 206091
Marketing start
Listing expires
Other FDA classes
Amides (Chemical structure)Local Anesthesia (Physiologic effect)
Identifiers
Product ID 67457-798_8f7315e1-caa4-49c4-aea2-2c5157dcf528SPL ID 8f7315e1-caa4-49c4-aea2-2c5157dcf528SPL set ID 9e1d1b15-c224-4ff4-a39d-3b9cebfc8403RxCUI 1734347, 1734355UNII V910P86109
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

N467457079899 followed by a unit qualifier and the quantity

Package 67457-0798-99. 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 .

Indications (excerpt from the label)

Ropivacaine hydrochloride injection 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 cesarean section; major nerve block; local infiltration Acute Pain Management …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 67457-798

What is NDC 67457-798?
67457-798 is the product NDC for Ropivacaine Hydrochloride, Ropivacaine hydrochloride 2 mg/mL injection, solution, listed with the FDA by Mylan Institutional LLC. 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?
Mylan Institutional LLC, NDC labeler code 67457. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Ropivacaine HydrochlorideRopivacaine hydrochloride 150 mg/30mLInjectionEpidural, Infiltration, PerineuralArmas Pharmaceuticals Inc.72485-51972485-0519-10
Ropivacaine HydrochlorideRopivacaine hydrochloride 2 mg/mLInjectionEpidural, InfiltrationHikma Pharmaceuticals USA Inc.0143-926300143-9263-10
Ropivacaine HydrochlorideRopivacaine hydrochloride 5 mg/mLInjectionEpidural, InfiltrationHikma Pharmaceuticals USA Inc.0143-926400143-9264-10
Ropivacaine HydrochlorideRopivacaine hydrochloride 7.5 mg/mLInjectionEpiduralHikma Pharmaceuticals USA Inc.0143-926500143-9265-10
Ropivacaine HydrochlorideRopivacaine hydrochloride 10 mg/mLInjectionEpiduralHikma Pharmaceuticals USA Inc.0143-926600143-9266-10
Ropivacaine HydrochlorideRopivacaine hydrochloride 2 mg/mLInjection, SolutionEpidural, Infiltration, PerineuralHikma Pharmaceuticals USA Inc.0143-919500143-9195-24
Ropivacaine HydrochlorideRopivacaine hydrochloride 2 mg/mLInjection, SolutionEpidural, Infiltration, PerineuralHikma Pharmaceuticals USA Inc.0143-919600143-9196-12
Ropivacaine HydrochlorideRopivacaine hydrochloride 5 mg/mLInjection, SolutionEpidural, Infiltration, PerineuralHikma Pharmaceuticals USA Inc.0143-919700143-9197-24
Ropivacaine HydrochlorideRopivacaine hydrochloride 2 mg/mLInjection, SolutionEpidural, InfiltrationGlenmark Pharmaceuticals Inc., USA68462-77768462-0777-35
Ropivacaine HydrochlorideRopivacaine hydrochloride 5 mg/mLInjection, SolutionEpidural, Infiltration, PerineuralGlenmark Pharmaceuticals Inc., USA68462-77868462-0778-5568462-0778-74

All 66 Ropivacaine Hydrochloride NDCs

Other NDCs under ANDA 206091

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

FDA NDC Directory listings under ANDA 206091
ProductStrengthForm · routeLabelerProduct NDC
Ropivacaine HydrochlorideRopivacaine hydrochloride 2 mg/mLInjection, SolutionEpidural, Infiltration, PerineuralMylan Institutional LLC67457-799

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