Tri-Sprintec
- Product NDC
- 21695-770
- 11-digit product format
- 216950770
- Labeler code
- 21695
- Product ID
- 21695-770_7fd4976d-720c-40ee-8723-a703645d4ff0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- norgestimate and ethinyl estradiol
- Dosage form
- KIT
- Labeler
- Rebel Distributors Corp
- Application
- ANDA075808
- Marketing category
- ANDA
- Marketing start
- 2011-01-25
- Marketing end
- 0000-00-00
- Active strength
- 0
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 21695-770-01 | 2019-09-24 | C162847 | 48780-1 | 934fe258-4cdd-48b1-e053-8cdaa90a720a | Tri-Sprintec ® (norgestimate and ethinyl estradiol tablets - triphasic regimen) PATIENTS SHOULD BE COUNSELED THAT THIS PRODUCT DOES NOT PROTECT AGAINST HIV INFECTION (AIDS) AND OTHER SEXUALLY TRANSMITTED DISEASES. Rx only |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 21695-770-01 | Tri-Sprintec | 1 in 1 POUCH | KIT | 1 | 1 | |
| 21695-770-01 | Tri-Sprintec | 1 in 1 BLISTER PACK | KIT | 1 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 21695-770-01 | EA - Each | 21695-770 | 04a52a20-a22d-4014-86e4-4c03e9414709 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 762333 | {7 (ethinyl estradiol 0.035 MG / norgestimate 0.18 MG Oral Tablet) / 7 (ethinyl estradiol 0.035 MG / norgestimate 0.215 MG Oral Tablet) / 7 (ethinyl estradiol 0.035 MG / norgestimate 0.25 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [Tri-Sprintec 28 Day] | BPCK | 7fd4976d-720c-40ee-8723-a703645d4ff0 | 1 |
| 749784 | {7 (ethinyl estradiol 0.035 MG / norgestimate 0.18 MG Oral Tablet) / 7 (ethinyl estradiol 0.035 MG / norgestimate 0.215 MG Oral Tablet) / 7 (ethinyl estradiol 0.035 MG / norgestimate 0.25 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack | GPCK | 7fd4976d-720c-40ee-8723-a703645d4ff0 | 1 |
| 749784 | Eth estra-Norgestim 0.035-0.18 MG (7) Oral Tablet / Eth estra-Norgestim 0.035-0.215 MG (7) Oral Tablet / Eth estra-Norgestim 0.035-0.25 MG (7) Oral Tablet / Inert 1 MG (7) Oral Tablet 28 Day Pack | PSN | 7fd4976d-720c-40ee-8723-a703645d4ff0 | 1 |
| 748797 | inert 1 MG Oral Tablet | PSN | 7fd4976d-720c-40ee-8723-a703645d4ff0 | 1 |
| 406396 | norgestimate 0.18 MG / ethinyl estradiol 0.035 MG Oral Tablet | PSN | 7fd4976d-720c-40ee-8723-a703645d4ff0 | 1 |
| 687424 | norgestimate 0.215 MG / ethinyl estradiol 0.035 MG Oral Tablet | PSN | 7fd4976d-720c-40ee-8723-a703645d4ff0 | 1 |
| 240128 | norgestimate 0.25 MG / ethinyl estradiol 0.035 MG Oral Tablet | PSN | 7fd4976d-720c-40ee-8723-a703645d4ff0 | 1 |
| 762333 | Tri-Sprintec 28 Day Pack | PSN | 7fd4976d-720c-40ee-8723-a703645d4ff0 | 1 |
| 406396 | ethinyl estradiol 0.035 MG / norgestimate 0.18 MG Oral Tablet | SCD | 7fd4976d-720c-40ee-8723-a703645d4ff0 | 1 |
| 687424 | ethinyl estradiol 0.035 MG / norgestimate 0.215 MG Oral Tablet | SCD | 7fd4976d-720c-40ee-8723-a703645d4ff0 | 1 |
| 240128 | ethinyl estradiol 0.035 MG / norgestimate 0.25 MG Oral Tablet | SCD | 7fd4976d-720c-40ee-8723-a703645d4ff0 | 1 |
| 748797 | inert ingredients 1 MG Oral Tablet | SCD | 7fd4976d-720c-40ee-8723-a703645d4ff0 | 1 |
| 240128 | ethinyl estradiol 35 MCG / norgestimate 0.25 MG Oral Tablet | SY | 7fd4976d-720c-40ee-8723-a703645d4ff0 | 1 |
| 762333 | Tri-Sprintec 28 Day Pack | SY | 7fd4976d-720c-40ee-8723-a703645d4ff0 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 21695-770-01 | 21695077001 | 1 in 1 POUCH | Historical |