NDC codes

FDA NDC Directory
Product NDC (as listed)63629-8608Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63629-8608Add 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
63629-8608-1636298608012 TUBE in 1 CARTON (63629-8608-1) / 140 g in 1 TUBEMarketed from Jul 9, 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)
Ammonium Lactate
Generic name (nonproprietary)
ammonium lactate
Active ingredients
Ammonium lactate — 12 g/100g
Dosage form
Cream
Route
Topical
Labeler
Bryant Ranch PrepackNDC labeler code 63629
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 075774
Marketing start
Listing expires
Other FDA classes
Acidifying Activity (Mechanism)
Identifiers
Product ID 63629-8608_f9b57c62-5ff4-4103-b5d7-dc22792c0e02SPL ID f9b57c62-5ff4-4103-b5d7-dc22792c0e02SPL set ID 170f8764-a180-49fa-b406-44f5b7921a66RxCUI 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

N463629860801 followed by a unit qualifier and the quantity

Package 63629-8608-01. 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)

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 63629-8608

What is NDC 63629-8608?
63629-8608 is the product NDC for Ammonium Lactate, Ammonium lactate 12 g/100g cream, 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?
Ammonium Lactate.
What is the active ingredient?
Ammonium lactate.
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 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 120 mg/gCreamTopicalREMEDYREPACK INC.70518-361970518-3619-00
Ammonium LactateAmmonium lactate 12 g/100gCreamTopicalPadagis Israel Pharmaceuticals Ltd45802-49345802-0493-2645802-0493-38
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 075774

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

FDA NDC Directory listings under ANDA 075774
ProductStrengthForm · routeLabelerProduct NDC
Ammonium LactateAmmonium lactate 12 g/100gCreamTopicalPadagis Israel Pharmaceuticals Ltd45802-493
Ammonium LactateAmmonium lactate 12 g/100gCreamTopicalBryant Ranch Prepack63629-8609
Ammonium LactateAmmonium lactate 12 g/100gCreamTopicalBryant Ranch Prepack72162-1413

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