Prescription drug · ANDA
Ammonium Lactate NDC 63629-8610
Ammonium lactate 12 g/100g · Lotion · Topical · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63629-8610-1 | 63629861001 | 225 g in 1 BOTTLE, PLASTIC (63629-8610-1)Marketed from Jun 20, 2006 |
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
- Lotion
- Route
- Topical
- Labeler
- Bryant Ranch PrepackNDC labeler code 63629
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075570
- Marketing start
- Listing expires
- Other FDA classes
- Acidifying Activity (Mechanism)
- Identifiers
- Product ID 63629-8610_00b2a93c-92de-90c6-e063-6294a90a6d33SPL ID 00b2a93c-92de-90c6-e063-6294a90a6d33SPL set ID 1d2adae5-0225-4e66-8f4f-14a5ef11e1d0RxCUI 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
N463629861001followed by a unit qualifier and the quantityPackage 63629-8610-01. 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 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.
About NDC 63629-8610
- What is NDC 63629-8610?
- 63629-8610 is the product NDC for Ammonium Lactate, Ammonium lactate 12 g/100g lotion, 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.
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 | 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 | Padagis Israel Pharmaceuticals Ltd | 45802-419 | 45802-0419-2645802-0419-54 |
| 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 |
| Ammonium Lactate | Ammonium lactate 120 mg/g | LotionTopical | A-S Medication Solutions | 50090-6587 | 50090-6587-00 |
| Ammonium Lactate | Ammonium lactate 120 mg/g | LotionTopical | Sun Pharmaceutical Industries, Inc. | 51672-1300 | 51672-1300-0551672-1300-09 |
Other NDCs under ANDA 075570
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 | LotionTopical | Padagis Israel Pharmaceuticals Ltd | 45802-419 |
| 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 |