NDC codes

FDA NDC Directory
Product NDC (as listed)63629-2538Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63629-2538Add 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
63629-2538-1636292538016362925380112 PACKET in 1 BOX (63629-2538-1) / 1 SUPPOSITORY in 1 PACKETMarketed from Jun 1, 2021

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 — 30 mg/1
Dosage form
Suppository
Route
Rectal
Labeler
Bryant Ranch PrepackNDC labeler code 63629
Product type
Prescription drug
Marketing category
Unapproved drug (other)
Marketing start
Listing expires
DEA schedule
CII
Other FDA classes
Full Opioid Agonists (Mechanism)
Identifiers
Product ID 63629-2538_cff101d7-1d35-4210-b1db-40b159bee3bfSPL ID cff101d7-1d35-4210-b1db-40b159bee3bfSPL set ID 996ac31e-589f-4d5a-84bc-8350e7ea864fRxCUI 892678UNII 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 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.

NDC on a medical claim

N463629253801 followed by a unit qualifier and the quantity

Package 63629-2538-01. 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 suppositories are indicated for the management of acute and chronic pain severe enough to require and opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1)] , reserve morphine sulfate suppositories for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: • Have not been tolerated, or are not expected to be tolerated, • Have not provided adequate analgesia, or are not expected to provide adequate analgesia Morphine sulfate suppositories is an opioid ag…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 63629-2538

What is NDC 63629-2538?
63629-2538 is the product NDC for Morphine Sulfate, Morphine sulfate 30 mg/1 suppository, 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

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