Prescription drug · ANDA

Morphine sulfate NDC 63304-758

Morphine sulfate 60 mg/1 · Tablet, Film coated, Extended release · Oral · Sun Pharmaceutical Industries, Inc.

NDC codes

FDA NDC Directory
Product NDC (as listed)63304-758Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63304-0758Add 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 NDC11-digit (billing)PackageCopy
63304-758-0163304075801100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63304-758-01)Marketed from May 11, 2012
63304-758-036330407580310 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63304-758-03)Marketed from May 11, 2012
63304-758-0563304075805500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63304-758-05)Marketed from May 11, 2012
63304-758-506330407585050 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63304-758-50)Marketed from May 11, 2012

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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 — 60 mg/1
Dosage form
Tablet, Film coated, Extended release
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 078761
Marketing start
Listing expires
DEA schedule
CII
Other FDA classes
Full Opioid Agonists (Mechanism)
Identifiers
Product ID 63304-758_4d15b836-54c7-2f40-e063-6294a90a68a2SPL ID 4d15b836-54c7-2f40-e063-6294a90a68a2SPL set ID 736c9b80-682c-4cda-bf18-61b18de0bd39RxCUI 891874, 891881, 891888, 891893, 892646UNII X3P646A2J0UPC 0363304453010, 0363304758016, 0363304452013, 0363304450019, 0363304451016
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

N463304075801 followed by a unit qualifier and the quantity

Package 63304-0758-01. 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 . This label includes a boxed warning.

Indications (excerpt from the label)

Morphine sulfate extended-release tablets are indicated for the management of severe andpersistent pain that requires an opioid analgesic and that cannot be adequately treated withalternative options, including immediate-release opioids. Limitations of Use Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at anydosage or duration and persist over the course of therapy [see Warnings and Precautions(5.2)] , reserve opioid analgesics, including morphine sulfate extended-release tablets, for usein patients for whom alternative treatment options are ineffective, not tolerated, or would beotherwise inadequate to provide sufficient management of pain. Morphine s…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 078761

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

FDA NDC Directory listings under ANDA 078761
ProductStrengthForm · routeLabelerProduct NDC
Morphine sulfateMorphine sulfate 15 mg/1Tablet, Film coated, Extended releaseOralBryant Ranch Prepack63629-1087
Morphine sulfateMorphine sulfate 30 mg/1Tablet, Film coated, Extended releaseOralBryant Ranch Prepack72162-1790
Morphine sulfateMorphine sulfate 30 mg/1Tablet, Film coated, Extended releaseOralBryant Ranch Prepack63629-1088
Morphine sulfateMorphine sulfate 60 mg/1Tablet, Film coated, Extended releaseOralBryant Ranch Prepack63629-1089
Morphine sulfateMorphine sulfate 200 mg/1Tablet, Film coated, Extended releaseOralBryant Ranch Prepack63629-1091
Morphine sulfateMorphine sulfate 15 mg/1Tablet, Film coated, Extended releaseOralBryant Ranch Prepack72162-1789
Morphine sulfateMorphine sulfate 100 mg/1Tablet, Film coated, Extended releaseOralBryant Ranch Prepack72162-1791
Morphine sulfateMorphine sulfate 200 mg/1Tablet, Film coated, Extended releaseOralBryant Ranch Prepack72162-1792
Morphine sulfateMorphine sulfate 60 mg/1Tablet, Film coated, Extended releaseOralBryant Ranch Prepack72162-1793
Morphine sulfateMorphine sulfate 15 mg/1Tablet, Film coated, Extended releaseOralSun Pharmaceutical Industries, Inc.63304-450
Morphine sulfateMorphine sulfate 30 mg/1Tablet, Film coated, Extended releaseOralSun Pharmaceutical Industries, Inc.63304-451
Morphine sulfateMorphine sulfate 100 mg/1Tablet, Film coated, Extended releaseOralSun Pharmaceutical Industries, Inc.63304-452
Morphine sulfateMorphine sulfate 200 mg/1Tablet, Film coated, Extended releaseOralSun Pharmaceutical Industries, Inc.63304-453
Morphine sulfateMorphine sulfate 30 mg/1Tablet, Film coated, Extended releaseOralBryant Ranch Prepack71335-0676
Morphine sulfateMorphine sulfate 60 mg/1Tablet, Film coated, Extended releaseOralBryant Ranch Prepack71335-0707
Morphine sulfateMorphine sulfate 15 mg/1Tablet, Film coated, Extended releaseOralBryant Ranch Prepack71335-0736
Morphine sulfateMorphine sulfate 100 mg/1Tablet, Film coated, Extended releaseOralBryant Ranch Prepack71335-3080

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Morphine sulfate NDC 63304-758 | Med-Code