Codeine sulfate NDC 0054-0245

NDC codes

FDA NDC Directory

Product NDC (as listed)0054-0245Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00054-0245Add 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
0054-0245-25	00054024525	100 TABLET in 1 BOTTLE (0054-0245-25)Marketed from Jul 16, 2009

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): Codeine sulfate
Generic name (nonproprietary): codeine sulfate
Active ingredients: Codeine sulfate — 60 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Hikma Pharmaceuticals USA Inc.
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 022402
Marketing start: Jul 16, 2009
Listing expires: Dec 31, 2026
DEA schedule: CII
Other FDA classes: Full Opioid Agonists (Mechanism)
Identifiers: Product ID 0054-0245_b04f74f8-d960-4b7a-988a-372d9a1e1406SPL ID b04f74f8-d960-4b7a-988a-372d9a1e1406SPL set ID 010905f9-3bcb-4b50-9fe8-a3ad0010f14cRxCUI 997170, 997287, 997296UNII 11QV9BS0CB
Pharmacologic class: Opioid Agonist

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

N400054024525 followed by a unit qualifier and the quantity

Package 00054-0245-25. 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 22, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

Codeine Sulfate Tablets are indicated for the management of mild to moderate pain, where treatment with an opioid is appropriate and for which alternative treatments are inadequate. Limitations of Use: • Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions ( 5.1 )] , reserve opioid analgesics, including Codeine Sulfate Tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. Codeine Sulfate Tablets are an opioid agonist, indicated for the management…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 022402

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

FDA NDC Directory listings under NDA 022402
Product	Strength	Form · route	Labeler	Product NDC
Codeine sulfate	Codeine sulfate 15 mg/1	TabletOral	Hikma Pharmaceuticals USA Inc.	0054-0243
Codeine sulfate	Codeine sulfate 30 mg/1	TabletOral	Hikma Pharmaceuticals USA Inc.	0054-0244