What is NDC 0054-0243?

0054-0243 is the product NDC for Codeine sulfate, Codeine sulfate 15 mg/1 tablet, listed with the FDA by Hikma Pharmaceuticals USA Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Hikma Pharmaceuticals USA Inc., NDC labeler code 0054. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Codeine sulfate?

5 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Codeine sulfate NDC 0054-0243 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0054-0243Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00054-0243Add 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
0054-0243-24	0005402432400054024324	10 BLISTER PACK in 1 BOX (0054-0243-24) / 10 TABLET in 1 BLISTER PACKMarketed 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 — 15 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Hikma Pharmaceuticals USA Inc.NDC labeler code 0054
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 0054-0243_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

N400054024324 followed by a unit qualifier and the quantity

Package 00054-0243-24. 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)

About NDC 0054-0243

What is NDC 0054-0243?: 0054-0243 is the product NDC for Codeine sulfate, Codeine sulfate 15 mg/1 tablet, listed with the FDA by Hikma Pharmaceuticals USA Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Codeine sulfate.
What is the active ingredient?: Codeine sulfate.
Who is the labeler?: Hikma Pharmaceuticals USA Inc., NDC labeler code 0054. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Codeine sulfate?: 5 other product NDCs are listed under this name. See all Codeine sulfate 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 Codeine sulfate NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Codeine Sulfate	Codeine sulfate 30 mg/1	TabletOral	Lannett Company, Inc.	0527-1698	00527-1698-0100527-1698-91
Codeine Sulfate	Codeine sulfate 60 mg/1	TabletOral	Lannett Company, Inc.	0527-1699	00527-1699-01
Codeine Sulfate	Codeine sulfate 15 mg/1	TabletOral	Lannett Company, Inc.	0527-1727	00527-1727-91
Codeine sulfate	Codeine sulfate 30 mg/1	TabletOral	Hikma Pharmaceuticals USA Inc.	0054-0244	00054-0244-2400054-0244-25
Codeine sulfate	Codeine sulfate 60 mg/1	TabletOral	Hikma Pharmaceuticals USA Inc.	0054-0245	00054-0245-25

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 30 mg/1	TabletOral	Hikma Pharmaceuticals USA Inc.	0054-0244
Codeine sulfate	Codeine sulfate 60 mg/1	TabletOral	Hikma Pharmaceuticals USA Inc.	0054-0245