What is NDC 45802-419?

45802-419 is the product NDC for Ammonium Lactate, Ammonium lactate 12 g/100g lotion, listed with the FDA by Padagis Israel Pharmaceuticals Ltd. It has 2 package NDCs, shown above in 10- and 11-digit form.

Padagis Israel Pharmaceuticals Ltd, NDC labeler code 45802. 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?

13 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Ammonium Lactate NDC 45802-419 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)45802-419Labeler and product segments. Claims need a package NDC.

Product NDC at billing width45802-0419Add 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 NDC	11-digit (billing)	Package	Copy
45802-419-26	4580204192645802041926	400 g in 1 BOTTLE, PLASTIC (45802-419-26)Marketed from Jun 20, 2006
45802-419-54	4580204195445802041954	225 g in 1 BOTTLE, PLASTIC (45802-419-54)Marketed from Jun 20, 2006

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): Ammonium Lactate
Generic name (nonproprietary): ammonium lactate
Active ingredients: Ammonium lactate — 12 g/100g
Dosage form: Lotion
Route: Topical
Labeler: Padagis Israel Pharmaceuticals LtdNDC labeler code 45802
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 075570
Marketing start: Jun 20, 2006
Listing expires: Dec 31, 2027
Other FDA classes: Acidifying Activity (Mechanism)
Identifiers: Product ID 45802-419_99ce3b45-47f3-4669-ad2d-f073d4bb03c0SPL ID 99ce3b45-47f3-4669-ad2d-f073d4bb03c0SPL set ID dc3a6462-0f2c-4306-b5ef-c7b47395e959RxCUI 197362UNII 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

N445802041926 followed by a unit qualifier and the quantity

Package 45802-0419-26. 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 Jun 30, 2025.

Indications (excerpt from the label)

INDICATIONS AND USAGE Ammonium Lactate Lotion, 12% is indicated for the treatment of dry, scaly skin (xerosis) and ichthyosis vulgaris, and for the temporary relief of itching associated with these conditions.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 45802-419

What is NDC 45802-419?: 45802-419 is the product NDC for Ammonium Lactate, Ammonium lactate 12 g/100g lotion, listed with the FDA by Padagis Israel Pharmaceuticals Ltd. It has 2 package NDCs, 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?: Padagis Israel Pharmaceuticals Ltd, NDC labeler code 45802. 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?: 13 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
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Ammonium lactate	Ammonium lactate 120 mg/g	CreamTopical	Zydus Lifesciences Limited	70771-1988	70771-1988-0670771-1988-07
Ammonium lactate	Ammonium lactate 120 mg/g	CreamTopical	Viona Pharmaceuticals Inc	72578-203	72578-0203-1072578-0203-11
Ammonium Lactate	Ammonium lactate 120 mg/g	CreamTopical	REMEDYREPACK INC.	70518-3619	70518-3619-00
Ammonium Lactate	Ammonium lactate 12 g/100g	CreamTopical	Padagis Israel Pharmaceuticals Ltd	45802-493	45802-0493-2645802-0493-38
Ammonium Lactate	Ammonium lactate 12 g/100g	CreamTopical	Bryant Ranch Prepack	63629-8608	63629-8608-01
Ammonium Lactate	Ammonium lactate 12 g/100g	CreamTopical	Bryant Ranch Prepack	63629-8609	63629-8609-01
Ammonium Lactate	Ammonium lactate 12 g/100g	CreamTopical	Bryant Ranch Prepack	72162-1413	72162-1413-02
Ammonium Lactate	Ammonium lactate 12 g/100g	LotionTopical	Bryant Ranch Prepack	63629-8610	63629-8610-01
Ammonium Lactate	Ammonium lactate 12 g/100g	LotionTopical	Bryant Ranch Prepack	63629-8611	63629-8611-01
Ammonium Lactate	Ammonium lactate 12 g/100g	LotionTopical	Bryant Ranch Prepack	72162-1407	72162-1407-0272162-1407-04

All 14 Ammonium Lactate NDCs

Other NDCs under ANDA 075570

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

FDA NDC Directory listings under ANDA 075570
Product	Strength	Form · route	Labeler	Product NDC
Ammonium Lactate	Ammonium lactate 12 g/100g	LotionTopical	Bryant Ranch Prepack	63629-8610
Ammonium Lactate	Ammonium lactate 12 g/100g	LotionTopical	Bryant Ranch Prepack	63629-8611
Ammonium Lactate	Ammonium lactate 12 g/100g	LotionTopical	Bryant Ranch Prepack	72162-1407