What is NDC 0641-6127?

0641-6127 is the product NDC for Morphine Sulfate, Morphine sulfate 10 mg/mL injection, 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 0641. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Morphine Sulfate?

126 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Morphine Sulfate NDC 0641-6127 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0641-6127Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00641-6127Add 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
0641-6127-25	0064161272500641612725	25 VIAL, SINGLE-DOSE in 1 PACKAGE (0641-6127-25) / 1 mL in 1 VIAL, SINGLE-DOSE (0641-6127-01)Marketed from Jun 3, 2015

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): Morphine Sulfate
Generic name (nonproprietary): morphine sulfate
Active ingredients: Morphine sulfate — 10 mg/mL
Dosage form: Injection
Route: Intravenous
Labeler: Hikma Pharmaceuticals USA Inc.NDC labeler code 0641
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 205758
Marketing start: Jun 3, 2015
Listing expires: Dec 31, 2027
DEA schedule: CII
Other FDA classes: Full Opioid Agonists (Mechanism)
Identifiers: Product ID 0641-6127_fb513d10-94f4-45f5-8b30-fa82ef83e4e2SPL ID fb513d10-94f4-45f5-8b30-fa82ef83e4e2SPL set ID 6023606c-150c-40c5-9175-598efe2a56c3RxCUI 1731993, 1732006, 1732011UNII X3P646A2J0UPC 0306416126250, 0306416127257
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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

Administration

Drug administration (CPT 96360–96549)

When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.

How CPT relates to drug billing

NDC on a medical claim

N400641612725 followed by a unit qualifier and the quantity

Package 00641-6127-25. 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 Jul 12, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

Morphine Sulfate Injection is indicated for the management of pain severe enough to require an opioid analgesic 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 Morphine Sulfate Injection, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. Morphine Sulfate Injection is an opioid agonist indicated for the management of pain severe…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0641-6127

What is NDC 0641-6127?: 0641-6127 is the product NDC for Morphine Sulfate, Morphine sulfate 10 mg/mL injection, 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?: Morphine Sulfate.
What is the active ingredient?: Morphine sulfate.
Who is the labeler?: Hikma Pharmaceuticals USA Inc., NDC labeler code 0641. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Morphine Sulfate?: 126 other product NDCs are listed under this name. See all Morphine 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 Morphine Sulfate NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Morphine Sulfate	Morphine sulfate 15 mg/1	TabletOral	St. Mary's Medical Park Pharmacy	60760-893	60760-0893-60
Morphine Sulfate	Morphine sulfate 20 mg/mL	SolutionOral	American Health Packaging	68000-110	68000-0110-01
Morphine Sulfate	Morphine sulfate 20 mg/mL	SolutionOral	American Health Packaging	68000-111	68000-0111-05
Morphine Sulfate	Morphine sulfate 20 mg/mL	SolutionOral	American Health Packaging	68000-112	68000-0112-05
Morphine Sulfate	Morphine sulfate 20 mg/mL	SolutionOral	American Health Packaging	68000-113	68000-0113-03
Morphine Sulfate	Morphine sulfate 20 mg/mL	SolutionOral	American Health Packaging	68000-114	68000-0114-03
Morphine Sulfate	Morphine sulfate 10 mg/5mL	SolutionOral	American Health Packaging	60687-927	60687-0927-86
Morphine Sulfate	Morphine sulfate 10 mg/5mL	SolutionOral	PAI Holdings, LLC dba PAI Pharma	0121-4955	00121-4955-94
Morphine Sulfate	Morphine sulfate 100 mg/5mL	SolutionOral	Precision Dose, Inc.	68094-556	68094-0556-58
Morphine Sulfate	Morphine sulfate 100 mg/5mL	SolutionOral	Precision Dose, Inc.	68094-156	68094-0156-58

All 127 Morphine Sulfate NDCs

Other NDCs under ANDA 205758

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

FDA NDC Directory listings under ANDA 205758
Product	Strength	Form · route	Labeler	Product NDC
Morphine Sulfate	Morphine sulfate 4 mg/mL	InjectionIntravenous	Hikma Pharmaceuticals USA Inc.	0641-6125
Morphine Sulfate	Morphine sulfate 8 mg/mL	InjectionIntravenous	Hikma Pharmaceuticals USA Inc.	0641-6126
Morphine Sulfate	Morphine sulfate 4 mg/mL	InjectionIntravenous	Civica, Inc.	72572-440