What is NDC 57483-596?

57483-596 is the product NDC for Crcle Diclofenac Sodium Topical Gel 1%, Diclofenac sodium 10 mg/g gel, listed with the FDA by Innovus Pharmaceuticals Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Crcle Diclofenac Sodium Topical Gel 1% (Diclofenac Sodium Topical Gel 1%).

Innovus Pharmaceuticals Inc., NDC labeler code 57483. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Crcle Diclofenac Sodium Topical Gel 1%?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Crcle Diclofenac Sodium Topical Gel 1% NDC 57483-596

NDC codes

FDA NDC Directory

Product NDC (as listed)57483-596Labeler and product segments. Claims need a package NDC.

Product NDC at billing width57483-0596Add 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
57483-596-01	5748305960157483059601	1 TUBE in 1 CARTON (57483-596-01) / 150 g in 1 TUBEMarketed from Mar 31, 2023

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): Crcle Diclofenac Sodium Topical Gel 1%
Generic name (nonproprietary): diclofenac sodium topical gel 1%
Active ingredients: Diclofenac sodium — 10 mg/g
Dosage form: Gel
Route: Topical
Labeler: Innovus Pharmaceuticals Inc.NDC labeler code 57483
Product type: Over-the-counter drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 210986
Marketing start: Jan 10, 2022
Listing expires: Dec 31, 2026
Other FDA classes: Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Decreased Prostaglandin Production (Physiologic effect)
Identifiers: Product ID 57483-596_59143e11-f5ea-462d-a283-929ece6ba550SPL ID 59143e11-f5ea-462d-a283-929ece6ba550SPL set ID b373c202-5795-418f-989c-1ec5837145afRxCUI 855633UNII QTG126297Q
Pharmacologic class: Nonsteroidal Anti-inflammatory Drug

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. Topical products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N457483059601 followed by a unit qualifier and the quantity

Package 57483-0596-01. 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 Mar 24, 2023.

Indications (excerpt from the label)

Uses for the temporary relief of arthritis pain ONLY in the following areas: hand, wrist, elbow (upper body areas) foot, ankle, knee (lower body areas) this product may take up to 7 days to work for arthritis pain; it is not for immediate relief. If no pain relief in 7 days, stop use.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 57483-596

What is NDC 57483-596?: 57483-596 is the product NDC for Crcle Diclofenac Sodium Topical Gel 1%, Diclofenac sodium 10 mg/g gel, listed with the FDA by Innovus Pharmaceuticals Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Crcle Diclofenac Sodium Topical Gel 1% (Diclofenac Sodium Topical Gel 1%).
What is the active ingredient?: Diclofenac sodium.
Who is the labeler?: Innovus Pharmaceuticals Inc., NDC labeler code 57483. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Crcle Diclofenac Sodium Topical Gel 1%?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other NDCs under ANDA 210986

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

FDA NDC Directory listings under ANDA 210986
Product	Strength	Form · route	Labeler	Product NDC
Arthritis Paindiclofenac sodium topical gel, 1%	Diclofenac sodium 10 mg/g	GelTopical	Discount Drug Mart, Inc.	53943-523
Arthritis Paindiclofenac sodium topical gel, 1%	Diclofenac sodium 10 mg/g	GelTopical	Strategic Sourcing Services, LLC	70677-1125
Aspercreme Arthritisdiclofenac sodium	Diclofenac sodium .01 g/g	GelTopical	Chattem, Inc.	41167-0571
Curist Arthritis Reliefdiclofenac sodium	Diclofenac sodium 1 g/100g	GelTopical	Little Pharma, Inc.	72559-020
Diclofenac Sodiumdiclofenac sodium topical gel, 1%	Diclofenac sodium 10 mg/g	GelTopical	Encube Ethicals, Inc.	21922-044
Diclofenac Sodiumdiclofenac sodium topical gel, 1%	Diclofenac sodium 10 mg/g	GelTopical	Dr. Reddy's Laboratories Inc.	43598-885
Diclofenac Sodiumdiclofenac sodium topical gel, 1%	Diclofenac sodium 10 mg/g	GelTopical	Dr. Reddy's Laboratories Inc.	43598-977
Diclofenac Sodiumdiclofenac sodium topical gel, 1%,	Diclofenac sodium 10 mg/g	GelTopical	A-S Medication Solutions	50090-6998
Diclofenac Sodiumdiclofenac sodium topical gel, 1%,	Diclofenac sodium 10 mg/g	GelTopical	A-S Medication Solutions	50090-7243
Diclofenac Sodiumdiclofenac sodium topical gel, 1%	Diclofenac sodium 10 mg/g	GelTopical	GERI-CARE PHARMACEUTICALS CORP	57896-140
Diclofenac Sodiumdiclofenac sodium topical gel, 1%	Diclofenac sodium 10 mg/g	GelTopical	Simple Diagnostics	62379-401
Diclofenac Sodiumdiclofenac sodium topical gel, 1%	Diclofenac sodium 10 mg/g	GelTopical	Chain Drug Marketing Association INC	63868-730
Diclofenac Sodiumdiclofenac sodium topical gel, 1%	Diclofenac sodium 10 mg/g	GelTopical	BluePoint Laboratories	68001-621
Diclofenac Sodium	Diclofenac sodium 10 mg/g	GelTopical	NuCare Pharmaceuticals,Inc.	68071-2239
Diclofenac Sodiumdiclofenac sodium topical gel, 1%	Diclofenac sodium 10 mg/g	GelTopical	NuCare Pharmaceuticals,Inc.	68071-3483
Diclofenac Sodiumdiclofenac sodium topical gel, 1%,	Diclofenac sodium 10 mg/g	GelTopical	Preferred Pharmaceuticals, Inc.	68788-7772
Diclofenac Sodiumdiclofenac sodium 1%	Diclofenac sodium 10 mg/g	GelTopical	SOLA Pharmaceuticals	70512-106
Diclofenac Sodiumdiclofenac sodium topical gel, 1%	Diclofenac sodium 10 mg/g	GelTopical	IPG Pharmaceuticals, inc.	71085-084
Diclofenac Sodiumdiclofenac sodium topical gel, 1%,	Diclofenac sodium 10 mg/g	GelTopical	Proficient Rx LP	71205-552
Diclofenac Sodiumdiclofenac sodium topical gel, 1%	Diclofenac sodium 10 mg/g	GelTopical	Proficient Rx LP	71205-747

Showing 20 of 31.

Crcle Diclofenac Sodium Topical Gel 1% (Diclofenac sodium topical gel 1%) NDC 57483-596