What is NDC 70518-3378?

70518-3378 is the product NDC for Cephalexin, Cephalexin 500 mg/1 capsule, listed with the FDA by REMEDYREPACK INC.. It has 2 package NDCs, shown above in 10- and 11-digit form.

REMEDYREPACK INC., NDC labeler code 70518. 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?

183 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 70518-3378 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)70518-3378Labeler and product segments. Claims need a package NDC.

Product NDC at billing width70518-3378Add 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
70518-3378-0	7051833780070518337800	40 CAPSULE in 1 BOTTLE, PLASTIC (70518-3378-0)Marketed from Mar 8, 2022
70518-3378-4	7051833780470518337804	10 CAPSULE in 1 BOTTLE, PLASTIC (70518-3378-4)Marketed from May 13, 2026

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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: REMEDYREPACK INC.NDC labeler code 70518
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 090836
Marketing start: Mar 8, 2022
Listing expires: Dec 31, 2027
Other FDA classes: Cephalosporins (Chemical structure)
Identifiers: Product ID 70518-3378_587507d5-0e59-7ecc-e063-6394a90aded7SPL ID 587507d5-0e59-7ecc-e063-6394a90aded7SPL set ID c600a2c0-42ab-4be8-b9b1-59ba39494b3fRxCUI 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

N470518337800 followed by a unit qualifier and the quantity

Package 70518-3378-00. 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 Aug 7, 2026.

Indications (excerpt from the label)

Cephalexin 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 and other antibacterial drugs, Cephalexin 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 is indicated for the treatment of respiratory tract infections caused by susceptible …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 70518-3378

What is NDC 70518-3378?: 70518-3378 is the product NDC for Cephalexin, Cephalexin 500 mg/1 capsule, listed with the FDA by REMEDYREPACK INC.. It has 2 package NDCs, 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?: REMEDYREPACK INC., NDC labeler code 70518. 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?: 183 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 125 mg/5mL	Powder, For suspensionOral	Aurobindo Pharma Limited	59651-322	59651-0322-0159651-0322-02
Cephalexin	Cephalexin 250 mg/5mL	Powder, For suspensionOral	Aurobindo Pharma Limited	59651-323	59651-0323-0159651-0323-02
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+3 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 184 Cephalexin NDCs

Other NDCs under ANDA 090836

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

FDA NDC Directory listings under ANDA 090836
Product	Strength	Form · route	Labeler	Product NDC
Cephalexin	Cephalexin 500 mg/1	CapsuleOral	A-S Medication Solutions	50090-5948
Cephalexin	Cephalexin 500 mg/1	CapsuleOral	Ascend Laboratories, LLC	67877-219
Cephalexin	Cephalexin 250 mg/1	CapsuleOral	Ascend Laboratories, LLC	67877-220
Cephalexin	Cephalexin 250 mg/1	CapsuleOral	Asclemed USA, Inc.	76420-594
Cephalexin	Cephalexin 500 mg/1	CapsuleOral	Asclemed USA, Inc.	76420-592
Cephalexin	Cephalexin 500 mg/1	CapsuleOral	NuCare Pharmaceuticals,Inc.	68071-4355
Cephalexin	Cephalexin 500 mg/1	CapsuleOral	Sportpharm LLC	85766-191
Cephalexin	Cephalexin 333 mg/1	CapsuleOral	Asclemed USA, Inc.	76420-593
Cephalexin	Cephalexin 750 mg/1	CapsuleOral	Asclemed USA, Inc.	76420-595
Cephalexin	Cephalexin 250 mg/1	CapsuleOral	A-S Medication Solutions	50090-3291
Cephalexin	Cephalexin 250 mg/1	CapsuleOral	NuCare Pharmaceuticals,Inc.	68071-4434
Cephalexin	Cephalexin 333 mg/1	CapsuleOral	Ascend Laboratories, LLC	67877-254
Cephalexin	Cephalexin 750 mg/1	CapsuleOral	Ascend Laboratories, LLC	67877-255
Cephalexin	Cephalexin 500 mg/1	CapsuleOral	NuCare Pharmaceuticals,Inc.	68071-4429
Cephalexin	Cephalexin 500 mg/1	CapsuleOral	HAWAII REPACK, INC.	85534-0078
Cephalexin	Cephalexin 250 mg/1	CapsuleOral	HAWAII REPACK, INC.	85534-0076
Cephalexin	Cephalexin 333 mg/1	CapsuleOral	HAWAII REPACK, INC.	85534-0077
Cephalexin	Cephalexin 750 mg/1	CapsuleOral	HAWAII REPACK, INC.	85534-0079
Cephalexin	Cephalexin 500 mg/1	CapsuleOral	Bryant Ranch Prepack	63629-8856
Cephalexin	Cephalexin 500 mg/1	CapsuleOral	REMEDYREPACK INC.	70518-3059

Showing 20 of 40.