Ammonium Lactate
- Product NDC
- 70518-3619
- 11-digit product format
- 705183619
- Labeler code
- 70518
- Product ID
- 70518-3619_4f6bc7a2-ebb4-9e33-e063-6294a90a394e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ammonium Lactate
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA075883
- Marketing category
- ANDA
- Marketing start
- 2023-01-20
- Substance
- AMMONIUM LACTATE
- Active strength
- 120 mg/g
- Pharmacologic classes
- Acidifying Activity [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Ammonium Lactate
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| AMMONIUM LACTATE | 120 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 67M901L9NQ |
| Rxcui | 543460 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70518-3619-0 | Ammonium Lactate | 140 g in 1 TUBE | CREAM | 140 | | 5 |
| 70518-3619-0 | Ammonium Lactate | 2 in 1 CARTON | CREAM | 2 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70518-3619 | AMMONIUM LACTATE CREAM [REMEDYREPACK INC.] | 3 | Current NDC, 2 package rows | 20241122_030e8bd1-0ff3-479f-aa77-16fab701a111.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 70518-3619-0 | 70518361900 | 2 TUBE in 1 CARTON (70518-3619-0) / 140 g in 1 TUBE | 2 tube | 2023-01-20 | No | No | Historical |