NDC codes

FDA NDC Directory
Product NDC (as listed)70000-0108Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70000-0108Add 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
70000-0108-170000010801700000108011 BOTTLE in 1 CARTON (70000-0108-1) / 133 mL in 1 BOTTLEMarketed from Feb 19, 2013
70000-0108-270000010802700000108022 BOTTLE in 1 CARTON (70000-0108-2) / 133 mL in 1 BOTTLEMarketed from Feb 19, 2013

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)
Leader Ready to Use Saline LaxativeSuffix: Laxative
Generic name (nonproprietary)
sodium phosphate, dibasic and sodium phosphate, monobasic, unspecified form
Dosage form
Enema
Route
Rectal
Labeler
Cardinal HealthNDC labeler code 70000
Product type
Over-the-counter drug
Marketing category
OTC monograph drugApplication M 007
Marketing start
Marketing end
Other FDA classes
Increased Large Intestinal Motility (Physiologic effect)Increased Large Intestinal Motility (Physiologic effect)Inhibition Large Intestine Fluid/Electrolyte Absorption (Physiologic effect)Inhibition Large Intestine Fluid/Electrolyte Absorption (Physiologic effect)Osmotic Activity (Mechanism)Osmotic Activity (Mechanism)
Identifiers
Product ID 70000-0108_ca638819-da5f-49d5-8861-1b4db968785eSPL ID ca638819-da5f-49d5-8861-1b4db968785eSPL set ID 1b4f9c28-0547-4922-aa15-990c6fd9dc9fRxCUI 283100UNII GR686LBA74, 3980JIH2SW
Pharmacologic class
Osmotic Laxative

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

N470000010801 followed by a unit qualifier and the quantity

Package 70000-0108-01. 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 .

Indications (excerpt from the label)

Use relieves occasional constipation this product generally produces bowel movement in 1 to 5 minutes

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 70000-0108

What is NDC 70000-0108?
70000-0108 is the product NDC for Leader Ready to Use Saline Laxative, Sodium phosphate, Dibasic, Unspecified form 7 g/118mL; Sodium phosphate, Monobasic, Unspecified form 19 g/118mL enema, listed with the FDA by Cardinal Health. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Leader Ready to Use Saline Laxative (Sodium Phosphate, Dibasic and Sodium Phosphate, Monobasic, Unspecified Form).
What is the active ingredient?
Sodium phosphate, Dibasic, Unspecified form, Sodium phosphate, Monobasic, Unspecified form.
Who is the labeler?
Cardinal Health, NDC labeler code 70000. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Leader Ready to Use Saline Laxative?
None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other NDCs under M 007

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

FDA NDC Directory listings under M 007
ProductStrengthForm · routeLabelerProduct NDC
Stool Softenerdocusate sodiumDocusate sodium 100 mg/1Capsule, Liquid filledOralDolgencorp, Inc. (DOLLAR GENERAL & REXALL)55910-938
GlycerinGlycerin 1 g/1SuppositoryRectalChain Drug Consortium LLC68016-161
BisacodylBisacodyl 10 mg/1SuppositoryRectalCVS Pharmacy69842-816
Mineral oilMineral oil 100 mg/100mLOilOralEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)49035-035
Epsom Saltmagnesium sulfateMagnesium sulfate, Unspecified 1 g/gGranuleOral, TopicalWhole Foods Market42681-6412
Stratuscare Glycerin Laxative PediatricglycerinGlycerin 1 g/1SuppositoryRectalStratus Pharmaceuticals58980-409
Senokotstandardized senna concentrateSennosides 8.6 mg/1TabletOralAtlantis Consumer Healthcare, Inc.67618-300
SennaSennosides a and b 8.8 mg/5mLSolutionOralRugby Laboratories0536-1483
Milk Of Magnesia Cherrymagnesium hydroxideMagnesium hydroxide 1200 mg/15mLLiquidOralTOP CARE (TOPCO ASSOCIATES LLC)36800-684
Epsom Saltmagnesium sulfateMagnesium sulfate, Unspecified 1 g/gGranuleOral, TopicalWhole Foods Market42681-6413
Stratuscare Adult GlyceringlycerinGlycerin 2 g/1SuppositoryRectalStratus Pharmaceuticals58980-410
Phillips Fresh Mint Milk Of MagnesiaMagnesium hydroxide 1200 mg/15mLLiquidOralBayer HealthCare LLC.0280-0031
Senokot-Sstandardized senna concentrate and docusate sodiumSennosides 8.6 mg/1; Docusate sodium 50 mg/1TabletOralAtlantis Consumer Healthcare, Inc.67618-310
Senexon-Sdocusate sodium 50mg and sennosides 8.6mgSennosides 8.6 mg/1; Docusate sodium 50 mg/1Tablet, Film coatedOralRUGBY LABORATORIES0536-1247
Equate Kids Gentle Laxative SCmagnesium hydroxideMagnesium hydroxide 1200 mg/1Tablet, ChewableOralWalmart79903-252
Stratuscare BisacodylbisacodylBisacodyl 10 mg/1SuppositoryRectalStratus Pharmaceuticals58980-415
Epsom Saltmagnesium sulfateMagnesium sulfate heptahydrate 1 g/gGranule, For solutionOral, TopicalVi-Jon, LLC0869-0602
FleetbisacodylBisacodyl 5 mg/1Tablet, CoatedOralC.B. Fleet Company, Inc.0132-0401
Stool Softenerdocusate sodiumDocusate sodium 100 mg/1TabletOralGeri-Care Pharmaceuticals, Corp57896-421
Stool Softener Extra Strengthdocusate sodiumDocusate sodium 250 mg/1Capsule, Liquid filledOralCVS Pharmacy69842-740

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