ParaGard T 380A
- Product NDC
- 59365-5129
- 11-digit product format
- 593655129
- Labeler code
- 59365
- Product ID
- 59365-5129_898e2915-26f8-44c3-a16f-e45ab2352d06
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Copper
- Dosage form
- INTRAUTERINE DEVICE
- Route
- INTRAUTERINE
- Labeler
- CooperSurgical, Inc.
- Application
- NDA018680
- Marketing category
- NDA
- Marketing start
- 2024-08-15
- Substance
- COPPER
- Active strength
- 313.4 mg/1
- Pharmacologic classes
- Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Inhibit Ovum Fertilization [PE]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- ParaGard T 380A
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| COPPER | 313.4 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 789U1901C5 |
| Rxcui | 2267305, 2267310 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 59365-5129-1 | ParaGard T 380A | 1 in 1 POUCH | INTRAUTERINE DEVICE | 1 | | 3 |
| 59365-5129-1 | ParaGard T 380A | 1 in 1 CARTON | INTRAUTERINE DEVICE | 1 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 59365-5129 | PARAGARD T 380A (COPPER) INTRAUTERINE DEVICE [COOPERSURGICAL, INC.] | 1 | Current NDC, 2 package rows | 20240815_3c420b53-c95e-46af-aebd-73741be58391.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 |
|---|
| 59365-5129-1 | 59365512901 | 1 POUCH in 1 CARTON (59365-5129-1) / 1 INTRAUTERINE DEVICE in 1 POUCH | 1 pouch | 2024-08-15 | No | No | Historical |