NDC codes

FDA NDC Directory
Product NDC (as listed)27808-082Labeler and product segments. Claims need a package NDC.
Product NDC at billing width27808-0082Add 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
27808-082-0127808008201278080082011 BOTTLE, UNIT-DOSE in 1 CARTON (27808-082-01) / 30 mL in 1 BOTTLE, UNIT-DOSEMarketed from Sep 21, 2015
27808-082-0227808008202278080082021 BOTTLE, UNIT-DOSE in 1 CARTON (27808-082-02) / 120 mL in 1 BOTTLE, UNIT-DOSEMarketed from Sep 21, 2015

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 — 20 mg/mL
Dosage form
Solution
Route
Oral
Labeler
Cranbury Pharmaceuticals, LLCNDC labeler code 27808
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 203518
Marketing start
Listing expires
DEA schedule
CII
Other FDA classes
Full Opioid Agonists (Mechanism)
Identifiers
Product ID 27808-082_6c3bd932-ab35-4173-8087-f916e3d688ffSPL ID 6c3bd932-ab35-4173-8087-f916e3d688ffSPL set ID d8598654-94ad-4cfb-81d2-9b68e013a428RxCUI 892589, 892625UNII X3P646A2J0UPC 0327808082015, 0327808082022
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

N427808008201 followed by a unit qualifier and the quantity

Package 27808-0082-01. 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 Oral Solution 2 mg/mL is indicated for the management of: adults with pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. pediatric patients 2 years of age and older with pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Morphine Sulfate Oral Solution 20 mg/mL is indicated for use in opioid-tolerant adult patients who require higher doses of opioids for the management of pain severe enough to require an opioid analgesic and for which alternate treatments are inadequate. Limitations of Use: Because of the risks of addiction, abuse, misuse, overdose, and death, which can occ…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 27808-082

What is NDC 27808-082?
27808-082 is the product NDC for Morphine Sulfate, Morphine sulfate 20 mg/mL solution, listed with the FDA by Cranbury Pharmaceuticals, LLC. It has 2 package NDCs, 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?
Cranbury Pharmaceuticals, LLC, NDC labeler code 27808. 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 203518

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

FDA NDC Directory listings under ANDA 203518
ProductStrengthForm · routeLabelerProduct NDC
Morphine SulfateMorphine sulfate 20 mg/mLSolutionOralBryant Ranch Prepack63629-2301
Morphine SulfateMorphine sulfate 20 mg/mLSolutionOralBryant Ranch Prepack63629-2302
Morphine SulfateMorphine sulfate 20 mg/mLSolutionOralAmerican Health Packaging68000-110
Morphine SulfateMorphine sulfate 20 mg/mLSolutionOralAmerican Health Packaging68000-111
Morphine SulfateMorphine sulfate 20 mg/mLSolutionOralAmerican Health Packaging68000-112
Morphine SulfateMorphine sulfate 20 mg/mLSolutionOralAmerican Health Packaging68000-113
Morphine SulfateMorphine sulfate 20 mg/mLSolutionOralAmerican Health Packaging68000-114
Morphine SulfateMorphine sulfate 20 mg/mLSolutionOralBryant Ranch Prepack72162-1282

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