HALOETTE
- Product NDC
- 51862-148
- 11-digit product format
- 518620148
- Labeler code
- 51862
- Product ID
- 51862-148_e2064cbe-b7be-4e2d-9950-80dbc6a7b84f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- etonogestrel and ethinyl estradiol
- Dosage form
- INSERT, EXTENDED RELEASE
- Route
- VAGINAL
- Labeler
- Mayne Pharma Inc.
- Application
- ANDA211328
- Marketing category
- ANDA
- Marketing start
- 2022-12-01
- Marketing end
- 0000-00-00
- Substance
- ETHINYL ESTRADIOL; ETONOGESTREL
- Active strength
- 0 mg/d; mg/d
- Pharmacologic classes
- Estrogen Receptor Agonists [MoA], Estrogen [EPC], Progesterone Congeners [CS], Progestin [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51862-148 | HALOETTE (ETONOGESTREL AND ETHINYL ESTRADIOL) INSERT, EXTENDED RELEASE [MAYNE PHARMA INC.] | 5 | Legacy NDC | 20240420_f4081288-8cfc-477c-b3d7-357c9405a36f.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 51862-148-03 | 51862014803 | 3 POUCH in 1 CARTON (51862-148-03) > 21 d in 1 POUCH (51862-148-01) | 3 pouch | 2022-12-01 | 0000-00-00 | No | No | Current |