Prescription drug · ANDA

Morphine sulfate NDC 63629-1087

Morphine sulfate 15 mg/1 · Tablet, Film coated, Extended release · Oral · Bryant Ranch Prepack

NDC codes

FDA NDC Directory
Product NDC (as listed)63629-1087Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63629-1087Add 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
63629-1087-16362910870163629108701100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63629-1087-1)Marketed from May 11, 2012

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 15 mg/1
Dosage form
Tablet, Film coated, Extended release
Route
Oral
Labeler
Bryant Ranch PrepackNDC labeler code 63629
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 63629-1087_5147c1c6-5b73-4301-8aab-4b3dc59b8c74SPL ID 5147c1c6-5b73-4301-8aab-4b3dc59b8c74SPL set ID 2f15f27b-95ed-4cc8-8937-eae07917a6ddRxCUI 891881UNII X3P646A2J0
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

N463629108701 followed by a unit qualifier and the quantity

Package 63629-1087-01. 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 pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations [see Warnings and Precautions (5.1)] , reserve morphine sulfate extended-release tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequat…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 63629-1087

What is NDC 63629-1087?
63629-1087 is the product NDC for Morphine sulfate, Morphine sulfate 15 mg/1 tablet, film coated, extended release, listed with the FDA by Bryant Ranch Prepack. 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?
Bryant Ranch Prepack, NDC labeler code 63629. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Morphine SulfateMorphine sulfate 15 mg/1TabletOralSt. Mary's Medical Park Pharmacy60760-89360760-0893-60
Morphine SulfateMorphine sulfate 20 mg/mLSolutionOralAmerican Health Packaging68000-11068000-0110-01
Morphine SulfateMorphine sulfate 20 mg/mLSolutionOralAmerican Health Packaging68000-11168000-0111-05
Morphine SulfateMorphine sulfate 20 mg/mLSolutionOralAmerican Health Packaging68000-11268000-0112-05
Morphine SulfateMorphine sulfate 20 mg/mLSolutionOralAmerican Health Packaging68000-11368000-0113-03
Morphine SulfateMorphine sulfate 20 mg/mLSolutionOralAmerican Health Packaging68000-11468000-0114-03
Morphine SulfateMorphine sulfate 10 mg/5mLSolutionOralAmerican Health Packaging60687-92760687-0927-86
Morphine SulfateMorphine sulfate 10 mg/5mLSolutionOralPAI Holdings, LLC dba PAI Pharma0121-495500121-4955-94
Morphine SulfateMorphine sulfate 100 mg/5mLSolutionOralPrecision Dose, Inc.68094-55668094-0556-58
Morphine SulfateMorphine sulfate 100 mg/5mLSolutionOralPrecision Dose, Inc.68094-15668094-0156-58

All 127 Morphine sulfate NDCs

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 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 60 mg/1Tablet, Film coated, Extended releaseOralSun Pharmaceutical Industries, Inc.63304-758
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 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
Morphine sulfateMorphine sulfate 15 mg/1Tablet, Film coated, Extended releaseOralBryant Ranch Prepack72162-1789
Morphine sulfateMorphine sulfate 30 mg/1Tablet, Film coated, Extended releaseOralBryant Ranch Prepack72162-1790
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

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