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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	51862-148		D	Discontinued by firm		2026-08-03
excluded package	package	51862-148	51862-148-03	D	Discontinued by firm		2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 6 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	51862-148-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	51862-148-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	51862-148-03	`1332a3947898…`	`d4bfe170f9cd…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A211328-001	HALOETTE	ETHINYL ESTRADIOL; ETONOGESTREL	0.015MG/24HR;0.12MG/24HR	RING / VAGINAL	AB		2022-08-05

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A211328-001	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A211328-001	HALOETTE	0.015MG/24HR;0.12MG/24HR	RING / VAGINAL	AB	2022-08-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211328-001	HALOETTE	0.015MG/24HR;0.12MG/24HR	RING / VAGINAL	AB	2022-08-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211328-001	HALOETTE	0.015MG/24HR;0.12MG/24HR	RING / VAGINAL	AB	2022-08-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211328-001	HALOETTE	0.015MG/24HR;0.12MG/24HR	RING / VAGINAL	AB	2022-08-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211328-001	HALOETTE	0.015MG/24HR;0.12MG/24HR	RING / VAGINAL	AB	2022-08-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211328-001	HALOETTE	0.015MG/24HR;0.12MG/24HR	RING / VAGINAL	AB	2022-08-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211328-001	HALOETTE	0.015MG/24HR;0.12MG/24HR	RING / VAGINAL	AB	2022-08-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211328-001	HALOETTE	0.015MG/24HR;0.12MG/24HR	RING / VAGINAL	AB	2022-08-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211328-001	HALOETTE	0.015MG/24HR;0.12MG/24HR	RING / VAGINAL	AB	2022-08-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211328-001	HALOETTE	0.015MG/24HR;0.12MG/24HR	RING / VAGINAL	AB	2022-08-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211328-001	HALOETTE	0.015MG/24HR;0.12MG/24HR	RING / VAGINAL	AB	2022-08-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211328-001	HALOETTE	0.015MG/24HR;0.12MG/24HR	RING / VAGINAL	AB	2022-08-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211328-001	HALOETTE	0.015MG/24HR;0.12MG/24HR	RING / VAGINAL	AB	2022-08-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211328-001	HALOETTE	0.015MG/24HR;0.12MG/24HR	RING / VAGINAL	AB	2022-08-05	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211328-001	HALOETTE	0.015MG/24HR;0.12MG/24HR	RING / VAGINAL	AB	2022-08-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211328-001	HALOETTE	0.015MG/24HR;0.12MG/24HR	RING / VAGINAL	AB	2022-08-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211328-001	HALOETTE	0.015MG/24HR;0.12MG/24HR	RING / VAGINAL	AB	2022-08-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211328-001	HALOETTE	0.015MG/24HR;0.12MG/24HR	RING / VAGINAL	AB	2022-08-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211328-001	HALOETTE	0.015MG/24HR;0.12MG/24HR	RING / VAGINAL	AB	2022-08-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211328-001	HALOETTE	0.015MG/24HR;0.12MG/24HR	RING / VAGINAL	AB	2022-08-05	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211328-001	HALOETTE	0.015MG/24HR;0.12MG/24HR	RING / VAGINAL	AB	2022-08-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211328-001	HALOETTE	0.015MG/24HR;0.12MG/24HR	RING / VAGINAL	AB	2022-08-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211328-001	HALOETTE	0.015MG/24HR;0.12MG/24HR	RING / VAGINAL	AB	2022-08-05	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211328-001	HALOETTE	0.015MG/24HR;0.12MG/24HR	RING / VAGINAL	AB	2022-08-05	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211328-001	HALOETTE	0.015MG/24HR;0.12MG/24HR	RING / VAGINAL	AB	2022-08-05	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211328-001	HALOETTE	0.015MG/24HR;0.12MG/24HR	RING / VAGINAL	AB	2022-08-05	`e64feba35796…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211328-001	HALOETTE	0.015MG/24HR;0.12MG/24HR	RING / VAGINAL	AB	2022-08-05	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A211328-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211328-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211328-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211328-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211328-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211328-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211328-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211328-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211328-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211328-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211328-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211328-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211328-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211328-001	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211328-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211328-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211328-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211328-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211328-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211328-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211328-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211328-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211328-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211328-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211328-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211328-001	AB	1	`e64feba35796…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211328-001	AB	1	`a50c72e98297…`

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2026-01-26	These highlights do not include all the information needed to use HALOETTE safely and effectively. See full prescribing information for HALOETTE. HALOETTE ® (etonogestrel and ethinyl estradiol vaginal ring) Initial U.S. Approval: 2001
2025-07-29	These highlights do not include all the information needed to use HALOETTE safely and effectively. See full prescribing information for HALOETTE. HALOETTE ® (etonogestrel and ethinyl estradiol vaginal ring) Initial U.S. Approval: 2001
2024-04-19	These highlights do not include all the information needed to use HALOETTE safely and effectively. See full prescribing information for HALOETTE. HALOETTE ® (etonogestrel and ethinyl estradiol vaginal ring) Initial U.S. Approval: 2001
2024-01-30	These highlights do not include all the information needed to use HALOETTE safely and effectively. See full prescribing information for HALOETTE. HALOETTE ® (etonogestrel and ethinyl estradiol vaginal ring) Initial U.S. Approval: 2001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51862-148-01	EA - Each	51862-148	5baa1447-c212-4531-91d3-bf385259cd97	1	2023-01-09
51862-148-03	EA - Each	51862-148	44264815-c949-41a0-91dc-03264eab0d0f	1	2023-01-09

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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
423D2T571U	ETHINYL ESTRADIOL	57-63-6	ETHINYL ESTRADIOL
304GTH6RNH	ETONOGESTREL	54048-10-1	ETONOGESTREL

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
HALOETTE - Mayne Pharma Inc. \| Mithra Pharmaceuticals CDMO S.A.	Mayne Pharma Inc. \| Mithra Pharmaceuticals CDMO S.A.	2024-04-19	HUMAN PRESCRIPTION DRUG LABEL	5