What is NDC 0093-1078?

0093-1078 is the product NDC for Cefprozil, Cefprozil 500 mg/1 tablet, film coated, listed with the FDA by Teva Pharmaceuticals USA, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Teva Pharmaceuticals USA, Inc., NDC labeler code 0093. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Cefprozil?

21 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Cefprozil NDC 0093-1078 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0093-1078Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00093-1078Add 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
0093-1078-53	0009310785300093107853	50 TABLET, FILM COATED in 1 BOTTLE (0093-1078-53)Marketed from Dec 23, 2005

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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): Cefprozil
Generic name (nonproprietary): cefprozil
Active ingredients: Cefprozil — 500 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Teva Pharmaceuticals USA, Inc.NDC labeler code 0093
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 065208
Marketing start: Dec 23, 2005
Listing expires: Dec 31, 2026
Identifiers: Product ID 0093-1078_c226712f-00c2-407f-8b40-5ed1be54dfb8SPL ID c226712f-00c2-407f-8b40-5ed1be54dfb8SPL set ID 3391de8b-7bc9-4624-a5c4-836135b39d99RxCUI 197452, 197453UNII 4W0459ZA4V

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

N400093107853 followed by a unit qualifier and the quantity

Package 00093-1078-53. 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 31, 2018.

Indications (excerpt from the label)

INDICATIONS AND USAGE Cefprozil tablets are indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below: UPPER RESPIRATORY TRACT Pharyngitis/tonsillitis caused by Streptococcus pyogenes . NOTE: The usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever, is penicillin given by the intramuscular route. Cefprozil is generally effective in the eradication of Streptococcus pyogenes from the nasopharynx; however, substantial data establishing the efficacy of cefprozil in the subsequent prevention of rheumatic fever are no…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0093-1078

What is NDC 0093-1078?: 0093-1078 is the product NDC for Cefprozil, Cefprozil 500 mg/1 tablet, film coated, listed with the FDA by Teva Pharmaceuticals USA, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Cefprozil.
What is the active ingredient?: Cefprozil.
Who is the labeler?: Teva Pharmaceuticals USA, Inc., NDC labeler code 0093. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Cefprozil?: 21 other product NDCs are listed under this name. See all Cefprozil 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 Cefprozil NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Cefprozil	Cefprozil 250 mg/5mL	Powder, For suspensionOral	Lupin Pharmaceuticals, Inc.	68180-273	68180-0273-0168180-0273-0268180-0273-03
Cefprozil	Cefprozil 500 mg/1	Tablet, Film coatedOral	Ascend Laboratories, LLC	67877-243	67877-0243-50
Cefprozil	Cefprozil 250 mg/1	Tablet, Film coatedOral	Ascend Laboratories, LLC	67877-244	67877-0244-01
Cefprozil	Cefprozil 250 mg/1	Tablet, Film coatedOral	NorthStar Rx LLC	16714-398	16714-0398-01
Cefprozil	Cefprozil 500 mg/1	Tablet, Film coatedOral	NorthStar Rx LLC	16714-399	16714-0399-01
Cefprozil	Cefprozil 500 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-1710	50090-1710-00
Cefprozil	Cefprozil 250 mg/1	Tablet, Film coatedOral	Rising Pharma Holdings, Inc.	57237-036	57237-0036-01
Cefprozil	Cefprozil 500 mg/1	Tablet, Film coatedOral	Rising Pharma Holdings, Inc.	57237-037	57237-0037-0157237-0037-50
Cefprozil	Cefprozil 250 mg/1	Tablet, Film coatedOral	Aurobindo Pharma Limited	65862-068	65862-0068-0165862-0068-0565862-0068-30+1 more
Cefprozil	Cefprozil 125 mg/5mL	Powder, For suspensionOral	NorthStar Rx LLC	16714-396	16714-0396-03

All 22 Cefprozil NDCs

Other NDCs under ANDA 065208

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

FDA NDC Directory listings under ANDA 065208
Product	Strength	Form · route	Labeler	Product NDC
Cefprozil	Cefprozil 250 mg/1	Tablet, Film coatedOral	Teva Pharmaceuticals USA, Inc.	0093-1077