Prescription drug · ANDA
Ammonium Lactate NDC 45802-493
Ammonium lactate 12 g/100g · Cream · Topical · Padagis Israel Pharmaceuticals Ltd
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 45802-493-26 | 4580204932645802049326 | 385 g in 1 BOTTLE, PUMP (45802-493-26)Marketed from Feb 19, 2007 | |
| 45802-493-38 | 4580204933845802049338 | 385 g in 1 BOTTLE (45802-493-38)Marketed from Mar 16, 2026 |
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
- Cream
- Route
- Topical
- Labeler
- Padagis Israel Pharmaceuticals LtdNDC labeler code 45802
- 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 45802-493_560c1e68-ccf1-4727-9838-30e4f17aef0aSPL ID 560c1e68-ccf1-4727-9838-30e4f17aef0aSPL set ID 7096d38e-2bd1-4374-9bf6-7fd09ef7509cRxCUI 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
N445802049326followed by a unit qualifier and the quantityPackage 45802-0493-26. 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 .
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.
About NDC 45802-493
- What is NDC 45802-493?
- 45802-493 is the product NDC for Ammonium Lactate, Ammonium lactate 12 g/100g cream, 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.
Related NDCs: other Ammonium Lactate products
Other finished products listed under the same name: strengths, forms and labelers.
| 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 | 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 | Padagis Israel Pharmaceuticals Ltd | 45802-419 | 45802-0419-2645802-0419-54 |
| 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 |
Other NDCs under ANDA 075774
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Ammonium Lactate | Ammonium lactate 12 g/100g | CreamTopical | Bryant Ranch Prepack | 63629-8608 |
| Ammonium Lactate | Ammonium lactate 12 g/100g | CreamTopical | Bryant Ranch Prepack | 63629-8609 |
| Ammonium Lactate | Ammonium lactate 12 g/100g | CreamTopical | Bryant Ranch Prepack | 72162-1413 |