NDC codes

FDA NDC Directory
Product NDC (as listed)70518-3619Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70518-3619Add 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
70518-3619-0705183619002 TUBE in 1 CARTON (70518-3619-0) / 140 g in 1 TUBEMarketed from Jan 20, 2023

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)
Ammonium Lactate
Generic name (nonproprietary)
ammonium lactate
Active ingredients
Ammonium lactate — 120 mg/g
Dosage form
Cream
Route
Topical
Labeler
REMEDYREPACK INC.NDC labeler code 70518
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 075883
Marketing start
Listing expires
Other FDA classes
Acidifying Activity (Mechanism)
Identifiers
Product ID 70518-3619_4f6bc7a2-ebb4-9e33-e063-6294a90a394eSPL ID 4f6bc7a2-ebb4-9e33-e063-6294a90a394eSPL set ID 030e8bd1-0ff3-479f-aa77-16fab701a111RxCUI 543460UNII 67M901L9NQ

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. Topical products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N470518361900 followed by a unit qualifier and the quantity

Package 70518-3619-00. 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 Ammonium Lactate Cream, 12% is indicated for the treatment of ichthyosis vulgaris and xerosis.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 70518-3619

What is NDC 70518-3619?
70518-3619 is the product NDC for Ammonium Lactate, Ammonium lactate 120 mg/g cream, listed with the FDA by REMEDYREPACK INC.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Ammonium Lactate.
What is the active ingredient?
Ammonium lactate.
Who is the labeler?
REMEDYREPACK INC., NDC labeler code 70518. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Ammonium Lactate?
11 other product NDCs are listed under this name. See all Ammonium Lactate 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 Ammonium Lactate NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Ammonium LactateAmmonium lactate 12 g/100gCreamTopicalPadagis Israel Pharmaceuticals Ltd45802-49345802-0493-2645802-0493-38
Ammonium LactateAmmonium lactate 12 g/100gCreamTopicalBryant Ranch Prepack63629-860863629-8608-01
Ammonium LactateAmmonium lactate 12 g/100gCreamTopicalBryant Ranch Prepack63629-860963629-8609-01
Ammonium LactateAmmonium lactate 12 g/100gCreamTopicalBryant Ranch Prepack72162-141372162-1413-02
Ammonium LactateAmmonium lactate 12 g/100gLotionTopicalPadagis Israel Pharmaceuticals Ltd45802-41945802-0419-2645802-0419-54
Ammonium LactateAmmonium lactate 12 g/100gLotionTopicalBryant Ranch Prepack63629-861063629-8610-01
Ammonium LactateAmmonium lactate 12 g/100gLotionTopicalBryant Ranch Prepack63629-861163629-8611-01
Ammonium LactateAmmonium lactate 12 g/100gLotionTopicalBryant Ranch Prepack72162-140772162-1407-0272162-1407-04
Ammonium LactateAmmonium lactate 120 mg/gLotionTopicalA-S Medication Solutions50090-658750090-6587-00
Ammonium LactateAmmonium lactate 120 mg/gLotionTopicalSun Pharmaceutical Industries, Inc.51672-130051672-1300-0551672-1300-09

All 12 Ammonium Lactate NDCs

Other NDCs under ANDA 075883

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

FDA NDC Directory listings under ANDA 075883
ProductStrengthForm · routeLabelerProduct NDC
Ammonium LactateAmmonium lactate 120 mg/gCreamTopicalSun Pharmaceutical Industries, Inc.51672-1301

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