Necon
- Product NDC
- 51862-892
- 11-digit product format
- 518620892
- Labeler code
- 51862
- Product ID
- 51862-892_61a14c7a-159a-4856-b564-a97aee2bec6e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- norethindrone and ethinyl estradiol
- Dosage form
- KIT
- Route
- ORAL
- Labeler
- Mayne Pharma Inc.
- Application
- ANDA091204
- Marketing category
- ANDA
- Marketing start
- 2020-10-12
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
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.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 51862-892 | 51862-892-03 | D | Discontinued by firm | 2026-10-05 |
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.
| Captured / source date | Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Archive | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 51862-892 | 51862-892-03 | D | Discontinued by firm | excluded / ndc_excluded.zip | d630ba8d3edf… | 732f749b63fb… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A091204-001 | WERA | ETHINYL ESTRADIOL; NORETHINDRONE | 0.035MG;0.5MG | TABLET / ORAL-28 | AB | RS | 2012-03-27 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A091204-001 | 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 | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A091204-001 | WERA | 0.035MG;0.5MG | TABLET / ORAL-28 | AB | RS | 2012-03-27 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A091204-001 | WERA | 0.035MG;0.5MG | TABLET / ORAL-28 | AB | RS | 2012-03-27 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A091204-001 | WERA | 0.035MG;0.5MG | TABLET / ORAL-28 | AB | RS | 2012-03-27 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091204-001 | WERA | 0.035MG;0.5MG | TABLET / ORAL-28 | AB | RS | 2012-03-27 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A091204-001 | WERA | 0.035MG;0.5MG | TABLET / ORAL-28 | AB | RS | 2012-03-27 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091204-001 | WERA | 0.035MG;0.5MG | TABLET / ORAL-28 | AB | RS | 2012-03-27 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091204-001 | WERA | 0.035MG;0.5MG | TABLET / ORAL-28 | AB | RS | 2012-03-27 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091204-001 | WERA | 0.035MG;0.5MG | TABLET / ORAL-28 | AB | RS | 2012-03-27 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091204-001 | WERA | 0.035MG;0.5MG | TABLET / ORAL-28 | AB | RS | 2012-03-27 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091204-001 | WERA | 0.035MG;0.5MG | TABLET / ORAL-28 | AB | RS | 2012-03-27 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091204-001 | WERA | 0.035MG;0.5MG | TABLET / ORAL-28 | AB | RS | 2012-03-27 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A091204-001 | WERA | 0.035MG;0.5MG | TABLET / ORAL-28 | AB | RS | 2012-03-27 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091204-001 | WERA | 0.035MG;0.5MG | TABLET / ORAL-28 | AB | RS | 2012-03-27 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091204-001 | WERA | 0.035MG;0.5MG | TABLET / ORAL-28 | AB | RS | 2012-03-27 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A091204-001 | WERA | 0.035MG;0.5MG | TABLET / ORAL-28 | AB | RS | 2012-03-27 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A091204-001 | WERA | 0.035MG;0.5MG | TABLET / ORAL-28 | AB | RS | 2012-03-27 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A091204-001 | WERA | 0.035MG;0.5MG | TABLET / ORAL-28 | AB | RS | 2012-03-27 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A091204-001 | WERA | 0.035MG;0.5MG | TABLET / ORAL-28 | AB | RS | 2012-03-27 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A091204-001 | WERA | 0.035MG;0.5MG | TABLET / ORAL-28 | AB | RS | 2012-03-27 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A091204-001 | WERA | 0.035MG;0.5MG | TABLET / ORAL-28 | AB | RS | 2012-03-27 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A091204-001 | WERA | 0.035MG;0.5MG | TABLET / ORAL-28 | AB | RS | 2012-03-27 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A091204-001 | WERA | 0.035MG;0.5MG | TABLET / ORAL-28 | AB | RS | 2012-03-27 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A091204-001 | WERA | 0.035MG;0.5MG | TABLET / ORAL-28 | AB | RS | 2012-03-27 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A091204-001 | WERA | 0.035MG;0.5MG | TABLET / ORAL-28 | AB | RS | 2012-03-27 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A091204-001 | WERA | 0.035MG;0.5MG | TABLET / ORAL-28 | AB | RS | 2012-03-27 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A091204-001 | WERA | 0.035MG;0.5MG | TABLET / ORAL-28 | AB | RS | 2012-03-27 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A091204-001 | WERA | 0.035MG;0.5MG | TABLET / ORAL-28 | AB | RS | 2012-03-27 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A091204-001 | WERA | 0.035MG;0.5MG | TABLET / ORAL-28 | AB | RS | 2012-03-27 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A091204-001 | WERA | 0.035MG;0.5MG | TABLET / ORAL-28 | AB | RS | 2012-03-27 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A091204-001 | WERA | 0.035MG;0.5MG | TABLET / ORAL-28 | AB | RS | 2012-03-27 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A091204-001 | WERA | 0.035MG;0.5MG | TABLET / ORAL-28 | AB | RS | 2012-03-27 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A091204-001 | WERA | 0.035MG;0.5MG | TABLET / ORAL-28 | AB | RS | 2012-03-27 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A091204-001 | WERA | 0.035MG;0.5MG | TABLET / ORAL-28 | AB | RS | 2012-03-27 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A091204-001 | WERA | 0.035MG;0.5MG | TABLET / ORAL-28 | AB | RS | 2012-03-27 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A091204-001 | WERA | 0.035MG;0.5MG | TABLET / ORAL-28 | AB | RS | 2012-03-27 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A091204-001 | WERA | 0.035MG;0.5MG | TABLET / ORAL-28 | AB | RS | 2012-03-27 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A091204-001 | WERA | 0.035MG;0.5MG | TABLET / ORAL-28 | AB | RS | 2012-03-27 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A091204-001 | WERA | 0.035MG;0.5MG | TABLET / ORAL-28 | AB | RS | 2012-03-27 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A091204-001 | WERA | 0.035MG;0.5MG | TABLET / ORAL-28 | AB | RS | 2012-03-27 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A091204-001 | WERA | 0.035MG;0.5MG | TABLET / ORAL-28 | AB | RS | 2012-03-27 | f41ea6bd6efb… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A091204-001 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A091204-001 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A091204-001 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091204-001 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A091204-001 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091204-001 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091204-001 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091204-001 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091204-001 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091204-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091204-001 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A091204-001 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091204-001 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091204-001 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A091204-001 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A091204-001 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A091204-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A091204-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A091204-001 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A091204-001 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A091204-001 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A091204-001 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A091204-001 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A091204-001 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A091204-001 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A091204-001 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A091204-001 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A091204-001 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A091204-001 | AB | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A091204-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A091204-001 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A091204-001 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A091204-001 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A091204-001 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A091204-001 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A091204-001 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A091204-001 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A091204-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A091204-001 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A091204-001 | AB | 1 | f41ea6bd6efb… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Necon
- Listing expiration
- 2026-12-31
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| e80714f4-cdfe-4d60-a4e1-b8c7b184cc46 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 51862-892-01 | Necon | 1 in 1 PACKET | KIT | 1 | 2 | |
| 51862-892-01 | Necon | 1 in 1 BLISTER PACK | KIT | 1 | 2 | |
| 51862-892-02 | Necon | 1 in 1 BLISTER PACK | KIT | 1 | 2 | |
| 51862-892-02 | Necon | 1 in 1 CARTON | KIT | 1 | 2 | |
| 51862-892-03 | Necon | 1 in 1 BLISTER PACK | KIT | 1 | 2 | |
| 51862-892-03 | Necon | 3 in 1 CARTON | KIT | 3 | 2 | |
| 51862-892-06 | Necon | 1 in 1 BLISTER PACK | KIT | 1 | 2 | |
| 51862-892-06 | Necon | 6 in 1 CARTON | KIT | 6 | 2 |
DailyMed Dashboard NDC Coverage#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Wera | NORETHINDRONE AND ETHINYL ESTRADIOL | Northstar Rx LLC | 638e4f36-1a27-4220-8ec9-3fa9d9b36c11 | 2026-04-15 | Boxed warning, Warnings, Adverse reactions | 091204 ANDA091204 |
| Necon | NORETHINDRONE AND ETHINYL ESTRADIOL | Mayne Pharma Inc. | e80714f4-cdfe-4d60-a4e1-b8c7b184cc46 | 2025-09-09 | Boxed warning, Warnings, Adverse reactions | 091204 ANDA091204 51862-892 |
| Necon | NORETHINDRONE AND ETHINYL ESTRADIOL | Dr. Reddy's Laboratories Inc. | 1ca12bf6-9583-4578-8411-51ad02a405ec | 2024-04-15 | Boxed warning, Warnings, Adverse reactions | 091204 ANDA091204 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 751875 | {21 (ethinyl estradiol 0.035 MG / norethindrone 0.5 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [Necon 0.5/35 28 Day] | BPCK | e80714f4-cdfe-4d60-a4e1-b8c7b184cc46 | 2 |
| 749879 | {21 (ethinyl estradiol 0.035 MG / norethindrone 0.5 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack | GPCK | e80714f4-cdfe-4d60-a4e1-b8c7b184cc46 | 2 |
| 749879 | Eth estra-Noreth 0.035-0.5 MG (21) Oral Tablet / Inert 1 MG (7) Oral Tablet 28 Day Pack | PSN | e80714f4-cdfe-4d60-a4e1-b8c7b184cc46 | 2 |
| 748797 | inert 1 MG Oral Tablet | PSN | e80714f4-cdfe-4d60-a4e1-b8c7b184cc46 | 2 |
| 751875 | Necon 0.5/35 28 Day Pack | PSN | e80714f4-cdfe-4d60-a4e1-b8c7b184cc46 | 2 |
| 310463 | norethindrone 0.5 MG / ethinyl estradiol 0.035 MG Oral Tablet | PSN | e80714f4-cdfe-4d60-a4e1-b8c7b184cc46 | 2 |
| 310463 | ethinyl estradiol 0.035 MG / norethindrone 0.5 MG Oral Tablet | SCD | e80714f4-cdfe-4d60-a4e1-b8c7b184cc46 | 2 |
| 748797 | inert ingredients 1 MG Oral Tablet | SCD | e80714f4-cdfe-4d60-a4e1-b8c7b184cc46 | 2 |
| 310463 | ethinyl estradiol 35 MCG / norethindrone 0.5 MG Oral Tablet | SY | e80714f4-cdfe-4d60-a4e1-b8c7b184cc46 | 2 |
| 751875 | Necon 0.5/35 28 Day Pack | SY | e80714f4-cdfe-4d60-a4e1-b8c7b184cc46 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 51862-892-01 | 51862089201 | 1 BLISTER PACK in 1 PACKET (51862-892-01) / 1 KIT in 1 BLISTER PACK | 1 blister pack | 2020-10-12 | 0000-00-00 | No | No | Current |
| 51862-892-02 | 51862089202 | 1 BLISTER PACK in 1 CARTON (51862-892-02) / 1 KIT in 1 BLISTER PACK | 1 blister pack | 2020-10-12 | 0000-00-00 | No | No | Current |
| 51862-892-03 | 51862089203 | 3 BLISTER PACK in 1 CARTON (51862-892-03) > 1 KIT in 1 BLISTER PACK | 3 blister pack | 2020-10-12 | 0000-00-00 | No | No | Current |
| 51862-892-06 | 51862089206 | 6 BLISTER PACK in 1 CARTON (51862-892-06) / 1 KIT in 1 BLISTER PACK | 6 blister pack | 2020-10-12 | 0000-00-00 | No | No | Current |