NDC codes

FDA NDC Directory
Product NDC (as listed)0121-0727Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00121-0727Add 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
0121-0727-160012107271600121072716473 mL in 1 BOTTLE (0121-0727-16)Marketed from Nov 1, 2010

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
Ranitidine
Generic name (nonproprietary)
ranitidine
Active ingredients
Ranitidine — 15 mg/mL
Dosage form
Syrup
Route
Oral
Labeler
Pharmaceutical Associates, Inc.NDC labeler code 0121
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 077405
Marketing start
Listing expires
Other FDA classes
Histamine H2 Receptor Antagonists (Mechanism)
Identifiers
Product ID 0121-0727_d56a22ea-5dab-e98a-e053-2a95a90a34c4SPL ID d56a22ea-5dab-e98a-e053-2a95a90a34c4SPL set ID d0da9dd6-c691-4614-99c7-531b0bf34837RxCUI 705610UNII 884KT10YB7

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

N400121072716 followed by a unit qualifier and the quantity

Package 00121-0727-16. 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)

INDICATIONS AND USAGE Ranitidine Syrup (Ranitidine Oral Solution USP) is indicated in: Short-term treatment of active duodenal ulcer. Most patients heal within 4 weeks. Studies available to date have not assessed the safety of ranitidine in uncomplicated duodenal ulcer for periods of more than 8 weeks. Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of acute ulcers. No placebo-controlled comparative studies have been carried out for periods of longer than 1 year. The treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome and systemic mastocytosis). Short-term treatment of active, benign gastric ulcer. Most patients heal within 6 …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0121-0727

What is NDC 0121-0727?
0121-0727 is the product NDC for Ranitidine, Ranitidine 15 mg/mL syrup, listed with the FDA by Pharmaceutical Associates, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Ranitidine.
What is the active ingredient?
Ranitidine.
Who is the labeler?
Pharmaceutical Associates, Inc., NDC labeler code 0121. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Ranitidine?
12 other product NDCs are listed under this name. See all Ranitidine 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 Ranitidine NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
RanitidineRanitidine hydrochloride 150 mg/1TabletOralAtland Pharmaceuticals, LLC71993-31471993-0314-30
RanitidineRanitidine hydrochloride 300 mg/1TabletOralAtland Pharmaceuticals, LLC71993-31571993-0315-30
RanitidineRanitidine hydrochloride 150 mg/1TabletOralRising Pharma Holdings, Inc.64980-63664980-0636-03
RanitidineRanitidine hydrochloride 300 mg/1TabletOralRising Pharma Holdings, Inc.64980-63764980-0637-03
RanitidineRanitidine hydrochloride 150 mg/1TabletOralGranules India Ltd62207-77362207-0773-3662207-0773-4162207-0773-47+1 more
RanitidineRanitidine hydrochloride 150 mg/1CapsuleOralAjanta Pharma USA Inc.27241-10927241-0109-0627241-0109-50
RanitidineRanitidine hydrochloride 300 mg/1CapsuleOralAjanta Pharma USA Inc.27241-11027241-0110-0327241-0110-10
RanitidineRanitidine 15 mg/mLSyrupOralPharmaceutical Associates, Inc.0121-472700121-4727-10
RanitidineRanitidine hydrochloride 150 mg/1TabletOralAmneal Pharmaceuticals of New York LLC53746-25353746-0253-0153746-0253-0553746-0253-10+2 more
RanitidineRanitidine hydrochloride 300 mg/1TabletOralAmneal Pharmaceuticals of New York LLC53746-25453746-0254-0153746-0254-0253746-0254-30

All 13 Ranitidine NDCs

Other NDCs under ANDA 077405

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

FDA NDC Directory listings under ANDA 077405
ProductStrengthForm · routeLabelerProduct NDC
RanitidineRanitidine 15 mg/mLSyrupOralPharmaceutical Associates, Inc.0121-4727

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