Norethindrone Acetate and Ethinyl Estradiol, and Ferrous Fumarate
- Product NDC
- 69238-1686
- 11-digit product format
- 692381686
- Labeler code
- 69238
- Product ID
- 69238-1686_eaacb828-e8db-45c4-882b-a6ddf46bf7f0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Norethindrone Acetate and Ethinyl Estradiol, and Ferrous Fumarate
- Dosage form
- KIT
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals NY LLC
- Application
- ANDA214292
- Marketing category
- ANDA
- Marketing start
- 2021-07-26
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A214292-001 | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE | ETHINYL ESTRADIOL; NORETHINDRONE ACETATE | 0.02MG;1MG | CAPSULE / ORAL | 2021-07-20 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A214292-001 | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE | 0.02MG;1MG | CAPSULE / ORAL | 2021-07-20 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A214292-001 | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE | 0.02MG;1MG | CAPSULE / ORAL | 2021-07-20 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A214292-001 | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE | 0.02MG;1MG | CAPSULE / ORAL | 2021-07-20 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A214292-001 | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE | 0.02MG;1MG | CAPSULE / ORAL | 2021-07-20 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A214292-001 | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE | 0.02MG;1MG | CAPSULE / ORAL | 2021-07-20 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A214292-001 | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE | 0.02MG;1MG | CAPSULE / ORAL | 2021-07-20 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A214292-001 | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE | 0.02MG;1MG | CAPSULE / ORAL | 2021-07-20 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A214292-001 | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE | 0.02MG;1MG | CAPSULE / ORAL | 2021-07-20 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A214292-001 | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE | 0.02MG;1MG | CAPSULE / ORAL | 2021-07-20 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A214292-001 | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE | 0.02MG;1MG | CAPSULE / ORAL | 2021-07-20 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A214292-001 | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE | 0.02MG;1MG | CAPSULE / ORAL | 2021-07-20 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A214292-001 | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE | 0.02MG;1MG | CAPSULE / ORAL | 2021-07-20 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A214292-001 | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE | 0.02MG;1MG | CAPSULE / ORAL | 2021-07-20 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A214292-001 | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE | 0.02MG;1MG | CAPSULE / ORAL | 2021-07-20 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A214292-001 | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE | 0.02MG;1MG | CAPSULE / ORAL | AB | 2021-07-20 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A214292-001 | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE | 0.02MG;1MG | CAPSULE / ORAL | AB | 2021-07-20 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A214292-001 | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE | 0.02MG;1MG | CAPSULE / ORAL | AB | 2021-07-20 | 4b0b4de00fa7… | |
| 2022-03-09 01:35 UTC | 2022-03 | A214292-001 | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE | 0.02MG;1MG | CAPSULE / ORAL | AB | 2021-07-20 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A214292-001 | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE | 0.02MG;1MG | CAPSULE / ORAL | AB | 2021-07-20 | 782e0a99824c… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A214292-001 | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE | 0.02MG;1MG | CAPSULE / ORAL | 2021-07-20 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A214292-001 | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE | 0.02MG;1MG | CAPSULE / ORAL | AB | 2021-07-20 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A214292-001 | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE | 0.02MG;1MG | CAPSULE / ORAL | AB | 2021-07-20 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A214292-001 | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE | 0.02MG;1MG | CAPSULE / ORAL | AB | 2021-07-20 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A214292-001 | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE | 0.02MG;1MG | CAPSULE / ORAL | AB | 2021-07-20 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A214292-001 | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE | 0.02MG;1MG | CAPSULE / ORAL | AB | 2021-07-20 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A214292-001 | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE | 0.02MG;1MG | CAPSULE / ORAL | AB | 2021-07-20 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A214292-001 | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE | 0.02MG;1MG | CAPSULE / ORAL | AB | 2021-07-20 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A214292-001 | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE | 0.02MG;1MG | CAPSULE / ORAL | AB | 2021-07-20 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A214292-001 | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE | 0.02MG;1MG | CAPSULE / ORAL | AB | 2021-07-20 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A214292-001 | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE | 0.02MG;1MG | CAPSULE / ORAL | AB | 2021-07-20 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | A214292-001 | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE | 0.02MG;1MG | CAPSULE / ORAL | AB | 2021-07-20 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A214292-001 | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE | 0.02MG;1MG | CAPSULE / ORAL | AB | 2021-07-20 | cb3db0bc1861… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A214292-001 | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE | 0.02MG;1MG | CAPSULE / ORAL | 2021-07-20 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A214292-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A214292-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A214292-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-03-09 01:35 UTC | 2022-03 | A214292-001 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A214292-001 | AB | 1 | 782e0a99824c… |
| 2024-02-18 07:12 UTC | 2024-02 | A214292-001 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A214292-001 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A214292-001 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A214292-001 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A214292-001 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A214292-001 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A214292-001 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A214292-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A214292-001 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A214292-001 | AB | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A214292-001 | AB | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A214292-001 | AB | 1 | cb3db0bc1861… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Norethindrone Acetate and Ethinyl Estradiol, and Ferrous Fumarate
- Listing expiration
- 2027-12-31
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| e145ebc7-b6c0-474b-a712-c6f3b2342998 | Available on FDA.report |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69238-1686-3 | Norethindrone Acetate and Ethinyl Estradiol, and Ferrous Fumarate | 5 in 1 TRAY | KIT | 5 | 12 | |
| 69238-1686-6 | Norethindrone Acetate and Ethinyl Estradiol, and Ferrous Fumarate | 1 in 1 CARTON | KIT | 1 | 12 | |
| 69238-1686-6 | Norethindrone Acetate and Ethinyl Estradiol, and Ferrous Fumarate | 1 in 1 BLISTER PACK | KIT | 1 | 12 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 69238-1686 | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL, AND FERROUS FUMARATE KIT [AMNEAL PHARMACEUTICALS NY LLC] | 12 | Current NDC, Legacy NDC, 3 package rows | 20230824_e145ebc7-b6c0-474b-a712-c6f3b2342998.zip |
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 |
|---|---|---|---|---|---|---|
| Norethindrone Acetate and Ethinyl Estradiol, and Ferrous Fumarate | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL, AND FERROUS FUMARATE | Amneal Pharmaceuticals LLC | e145ebc7-b6c0-474b-a712-c6f3b2342998 | 2023-07-27 | Boxed warning, Warnings, Adverse reactions | 214292 ANDA214292 69238-1686 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1421461 | {24 (ethinyl estradiol 0.02 MG / norethindrone acetate 1 MG Oral Capsule) / 4 (ferrous fumarate 75 MG Oral Capsule) } Pack | GPCK | e145ebc7-b6c0-474b-a712-c6f3b2342998 | 12 |
| 1421461 | Eth estra-Noreth Ac 0.02-1 MG (24) Oral Capsule / Ferr fum 75 MG (4) Oral Capsule 28 Day Pack | PSN | e145ebc7-b6c0-474b-a712-c6f3b2342998 | 12 |
| 1421459 | ethinyl estradiol 20 MCG / norethindrone acetate 1 MG Oral Capsule | PSN | e145ebc7-b6c0-474b-a712-c6f3b2342998 | 12 |
| 1421460 | ferrous fumarate 75 MG Oral Capsule | PSN | e145ebc7-b6c0-474b-a712-c6f3b2342998 | 12 |
| 1421459 | ethinyl estradiol 0.02 MG / norethindrone acetate 1 MG Oral Capsule | SCD | e145ebc7-b6c0-474b-a712-c6f3b2342998 | 12 |
| 1421460 | ferrous fumarate 75 MG Oral Capsule | SCD | e145ebc7-b6c0-474b-a712-c6f3b2342998 | 12 |
| 1421461 | ethinyl estradiol 0.02 MG / norethindrone acetate 1 MG Oral Capsule / ferrous fumarate 75 MG Oral Capsule 28 day Pack | SY | e145ebc7-b6c0-474b-a712-c6f3b2342998 | 12 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 69238-1686-3 | 69238168603 | 5 CARTON in 1 TRAY (69238-1686-3) / 1 BLISTER PACK in 1 CARTON (69238-1686-6) / 1 KIT in 1 BLISTER PACK | 5 carton | 2021-07-26 | 0000-00-00 | No | No | Current |
| 69238-1686-6 | 69238168606 | 1 in 1 CARTON | Historical |