What is NDC 69778-931?

69778-931 is the product NDC for Cephalexin, Cephalexin 500 mg/1 capsule, listed with the FDA by Pharma-C, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Pharma-C, Inc., NDC labeler code 69778. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Cephalexin?

185 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Cephalexin NDC 69778-931 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)69778-931Labeler and product segments. Claims need a package NDC.

Product NDC at billing width69778-0931Add 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
69778-931-04	69778093104	500 CAPSULE in 1 BOTTLE, PLASTIC (69778-931-04)Marketed from Oct 11, 2016

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): Cephalexin
Generic name (nonproprietary): cephalexin
Active ingredients: Cephalexin — 500 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Pharma-C, Inc.NDC labeler code 69778
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 065152
Marketing start: Oct 15, 2010
Listing expires: Dec 31, 2026
Other FDA classes: Cephalosporins (Chemical structure)
Identifiers: Product ID 69778-931_5f2379e6-9041-4de6-83a2-f63fa36db0d9SPL ID 5f2379e6-9041-4de6-83a2-f63fa36db0d9SPL set ID bf9a6c06-11fd-4fb7-9cf5-e8e787758c1cRxCUI 309112, 309114UNII OBN7UDS42Y
Pharmacologic class: Cephalosporin Antibacterial

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

N469778093104 followed by a unit qualifier and the quantity

Package 69778-0931-04. 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 Dec 9, 2016.

Indications (excerpt from the label)

1. INDICATIONS AND USAGE Cephalexin capsules, USP is a cephalosporin antibacterial drug indicated for the treatment of the following infections caused by susceptible isolates of designated bacteria: • Respiratory tract infection ( 1.1 ) • Otitis media ( 1.2 ) • Skin and skin structure infections ( 1.3 ) • Bone infections ( 1.4 ) • Genitourinary tract infections ( 1.5 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cephalexin capsules, USP and other antibacterial drugs, Cephalexin capsules, USP should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. ( 1.6 ) 1.1 Respiratory Tract Infections Cephalexin caps…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 69778-931

What is NDC 69778-931?: 69778-931 is the product NDC for Cephalexin, Cephalexin 500 mg/1 capsule, listed with the FDA by Pharma-C, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Cephalexin.
What is the active ingredient?: Cephalexin.
Who is the labeler?: Pharma-C, Inc., NDC labeler code 69778. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Cephalexin?: 185 other product NDCs are listed under this name. See all Cephalexin 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 Cephalexin NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Cephalexin	Cephalexin 500 mg/1	CapsuleOral	Preferred Pharmaceuticals Inc.	68788-4143	68788-4143-0168788-4143-0268788-4143-03+6 more
Cephalexin	Cephalexin 250 mg/1	CapsuleOral	Preferred Pharmaceuticals Inc.	68788-4167	68788-4167-0268788-4167-0368788-4167-04+3 more
Cephalexin	Cephalexin 250 mg/5mL	Powder, For suspensionOral	Aurobindo Pharma Limited	59651-323	59651-0323-0159651-0323-02
Cephalexin	Cephalexin 125 mg/5mL	Powder, For suspensionOral	Aurobindo Pharma Limited	59651-322	59651-0322-0159651-0322-02
Cephalexin	Cephalexin 500 mg/1	CapsuleOral	Coupler LLC	67046-1245	67046-1245-03
Cephalexin	Cephalexin 250 mg/1	CapsuleOral	AVKARE	42291-006	42291-0006-50
Cephalexin	Cephalexin 500 mg/1	CapsuleOral	AVKARE	42291-007	42291-0007-50
Cephalexin	Cephalexin 500 mg/1	CapsuleOral	Northwind Health Company, LLC	82868-095	82868-0095-1082868-0095-2082868-0095-21+2 more
Cephalexin	Cephalexin 250 mg/5mL	For suspensionOral	REMEDYREPACK INC.	70518-4511	70518-4511-00
Cephalexin	Cephalexin 250 mg/1	CapsuleOral	Coupler, LLC	67046-1533	67046-1533-03

All 186 Cephalexin NDCs

Other NDCs under ANDA 065152

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

FDA NDC Directory listings under ANDA 065152
Product	Strength	Form · route	Labeler	Product NDC
Cephalexin	Cephalexin 250 mg/1	CapsuleOral	Pharma-C, Inc.	69778-930