Enpresse
- Product NDC
- 0555-9047
- 11-digit product format
- 005559047
- Labeler code
- 0555
- Product ID
- 0555-9047_5f1d4816-8608-4f95-b62f-6ef55f4f03a8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Levonorgestrel and Ethinyl Estradiol
- Dosage form
- KIT
- Labeler
- Teva Pharmaceuticals USA, Inc.
- Application
- ANDA075809
- Marketing category
- ANDA
- Marketing start
- 2002-06-27
- Marketing end
- 0000-00-00
- Active strength
- 0
- 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.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 0555-9047 | D | Discontinued by firm | 2026-10-15 | ||
| excluded package | package | 0555-9047 | 0555-9047-58 | D | Discontinued by firm | 2026-10-15 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A075809-001 | ENPRESSE-21 | ETHINYL ESTRADIOL; LEVONORGESTREL | 0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG | TABLET / ORAL-21 | 2001-07-16 | ||
| A075809-002 | ENPRESSE-28 | ETHINYL ESTRADIOL; LEVONORGESTREL | 0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG | TABLET / ORAL-28 | AB | 2001-07-16 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A075809-002 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A075809-001 | ENPRESSE-21 | 0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG | TABLET / ORAL-21 | 2001-07-16 | c2088c7a36db… | ||
| 2026-10-15 13:18:30 | 2026-09 | A075809-002 | ENPRESSE-28 | 0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG | TABLET / ORAL-28 | AB | 2001-07-16 | c2088c7a36db… | |
| 2026-09-14 22:38:34 | 2026-08 | A075809-001 | ENPRESSE-21 | 0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG | TABLET / ORAL-21 | 2001-07-16 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A075809-002 | ENPRESSE-28 | 0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG | TABLET / ORAL-28 | AB | 2001-07-16 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A075809-001 | ENPRESSE-21 | 0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG | TABLET / ORAL-21 | 2001-07-16 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A075809-002 | ENPRESSE-28 | 0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG | TABLET / ORAL-28 | AB | 2001-07-16 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A075809-001 | ENPRESSE-21 | 0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG | TABLET / ORAL-21 | 2001-07-16 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A075809-002 | ENPRESSE-28 | 0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG | TABLET / ORAL-28 | AB | 2001-07-16 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075809-001 | ENPRESSE-21 | 0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG | TABLET / ORAL-21 | 2001-07-16 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075809-002 | ENPRESSE-28 | 0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG | TABLET / ORAL-28 | AB | 2001-07-16 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075809-001 | ENPRESSE-21 | 0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG | TABLET / ORAL-21 | 2001-07-16 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A075809-002 | ENPRESSE-28 | 0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG | TABLET / ORAL-28 | AB | 2001-07-16 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075809-001 | ENPRESSE-21 | 0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG | TABLET / ORAL-21 | 2001-07-16 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075809-002 | ENPRESSE-28 | 0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG | TABLET / ORAL-28 | AB | 2001-07-16 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075809-001 | ENPRESSE-21 | 0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG | TABLET / ORAL-21 | 2001-07-16 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075809-002 | ENPRESSE-28 | 0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG | TABLET / ORAL-28 | AB | 2001-07-16 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075809-001 | ENPRESSE-21 | 0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG | TABLET / ORAL-21 | 2001-07-16 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075809-002 | ENPRESSE-28 | 0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG | TABLET / ORAL-28 | AB | 2001-07-16 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075809-001 | ENPRESSE-21 | 0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG | TABLET / ORAL-21 | 2001-07-16 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075809-002 | ENPRESSE-28 | 0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG | TABLET / ORAL-28 | AB | 2001-07-16 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075809-001 | ENPRESSE-21 | 0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG | TABLET / ORAL-21 | 2001-07-16 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075809-002 | ENPRESSE-28 | 0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG | TABLET / ORAL-28 | AB | 2001-07-16 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075809-001 | ENPRESSE-21 | 0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG | TABLET / ORAL-21 | 2001-07-16 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075809-002 | ENPRESSE-28 | 0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG | TABLET / ORAL-28 | AB | 2001-07-16 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A075809-001 | ENPRESSE-21 | 0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG | TABLET / ORAL-21 | 2001-07-16 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A075809-002 | ENPRESSE-28 | 0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG | TABLET / ORAL-28 | AB | 2001-07-16 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075809-001 | ENPRESSE-21 | 0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG | TABLET / ORAL-21 | 2001-07-16 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075809-002 | ENPRESSE-28 | 0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG | TABLET / ORAL-28 | AB | 2001-07-16 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075809-001 | ENPRESSE-21 | 0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG | TABLET / ORAL-21 | 2001-07-16 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075809-002 | ENPRESSE-28 | 0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG | TABLET / ORAL-28 | AB | 2001-07-16 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075809-001 | ENPRESSE-21 | 0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG | TABLET / ORAL-21 | 2001-07-16 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075809-002 | ENPRESSE-28 | 0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG | TABLET / ORAL-28 | AB | 2001-07-16 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A075809-001 | ENPRESSE-21 | 0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG | TABLET / ORAL-21 | 2001-07-16 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A075809-002 | ENPRESSE-28 | 0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG | TABLET / ORAL-28 | AB | 2001-07-16 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A075809-001 | ENPRESSE-21 | 0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG | TABLET / ORAL-21 | 2001-07-16 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A075809-002 | ENPRESSE-28 | 0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG | TABLET / ORAL-28 | AB | 2001-07-16 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A075809-001 | ENPRESSE-21 | 0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG | TABLET / ORAL-21 | 2001-07-16 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A075809-002 | ENPRESSE-28 | 0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG | TABLET / ORAL-28 | AB | 2001-07-16 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A075809-001 | ENPRESSE-21 | 0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG | TABLET / ORAL-21 | 2001-07-16 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A075809-002 | ENPRESSE-28 | 0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG | TABLET / ORAL-28 | AB | 2001-07-16 | 4b0b4de00fa7… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2022-10-28 04:53 UTC | 2022-10 | A075809-002 | AB | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A075809-002 | AB | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A075809-002 | AB | 1 | cb3db0bc1861… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A075809-002 | AB | 1 | a50c72e98297… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0555-9047-58 | EA - Each | 0555-9047 | 9f06f36f-5515-4670-abb1-f27605866585 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 761977 | {6 (ethinyl estradiol 0.03 MG / levonorgestrel 0.05 MG Oral Tablet) / 10 (ethinyl estradiol 0.03 MG / levonorgestrel 0.125 MG Oral Tablet) / 5 (ethinyl estradiol 0.04 MG / levonorgestrel 0.075 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [Enpresse 28 Day] | BPCK | 6c095eec-8d92-4b07-8f9e-84bb8c9bc3f8 | 1 |
| 761977 | {6 (ethinyl estradiol 0.03 MG / levonorgestrel 0.05 MG Oral Tablet) / 10 (ethinyl estradiol 0.03 MG / levonorgestrel 0.125 MG Oral Tablet) / 5 (ethinyl estradiol 0.04 MG / levonorgestrel 0.075 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [Enpresse 28 Day] | BPCK | a3db80f8-5026-4954-aef5-dbf14c8c1b16 | 1 |
| 748832 | {6 (ethinyl estradiol 0.03 MG / levonorgestrel 0.05 MG Oral Tablet) / 10 (ethinyl estradiol 0.03 MG / levonorgestrel 0.125 MG Oral Tablet) / 5 (ethinyl estradiol 0.04 MG / levonorgestrel 0.075 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack | GPCK | a3db80f8-5026-4954-aef5-dbf14c8c1b16 | 1 |
| 748832 | {6 (ethinyl estradiol 0.03 MG / levonorgestrel 0.05 MG Oral Tablet) / 10 (ethinyl estradiol 0.03 MG / levonorgestrel 0.125 MG Oral Tablet) / 5 (ethinyl estradiol 0.04 MG / levonorgestrel 0.075 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack | GPCK | 6c095eec-8d92-4b07-8f9e-84bb8c9bc3f8 | 1 |
| 761977 | Enpresse 28 Day Triphasic Pack | PSN | a3db80f8-5026-4954-aef5-dbf14c8c1b16 | 1 |
| 761977 | Enpresse 28 Day Triphasic Pack | PSN | 6c095eec-8d92-4b07-8f9e-84bb8c9bc3f8 | 1 |
| 748832 | Eth estra-Levonorgest 0.03-0.05 MG (6) Oral Tablet / Eth estra-Levonorgest 0.03-0.125 MG (10) Oral Tablet / Eth estra-Levonorgest 0.04-0.075 MG (5) Oral Tablet / Inert 1 MG (7) Oral Tablet 28 Day Pack | PSN | a3db80f8-5026-4954-aef5-dbf14c8c1b16 | 1 |
| 748832 | Eth estra-Levonorgest 0.03-0.05 MG (6) Oral Tablet / Eth estra-Levonorgest 0.03-0.125 MG (10) Oral Tablet / Eth estra-Levonorgest 0.04-0.075 MG (5) Oral Tablet / Inert 1 MG (7) Oral Tablet 28 Day Pack | PSN | 6c095eec-8d92-4b07-8f9e-84bb8c9bc3f8 | 1 |
| 310230 | ethinyl estradiol 0.03 MG / levonorgestrel 0.05 MG Oral Tablet | PSN | a3db80f8-5026-4954-aef5-dbf14c8c1b16 | 1 |
| 310230 | ethinyl estradiol 0.03 MG / levonorgestrel 0.05 MG Oral Tablet | PSN | 6c095eec-8d92-4b07-8f9e-84bb8c9bc3f8 | 1 |
| 348804 | ethinyl estradiol 0.03 MG / levonorgestrel 0.125 MG Oral Tablet | PSN | 6c095eec-8d92-4b07-8f9e-84bb8c9bc3f8 | 1 |
| 348804 | ethinyl estradiol 0.03 MG / levonorgestrel 0.125 MG Oral Tablet | PSN | a3db80f8-5026-4954-aef5-dbf14c8c1b16 | 1 |
| 348805 | ethinyl estradiol 0.04 MG / levonorgestrel 0.075 MG Oral Tablet | PSN | 6c095eec-8d92-4b07-8f9e-84bb8c9bc3f8 | 1 |
| 348805 | ethinyl estradiol 0.04 MG / levonorgestrel 0.075 MG Oral Tablet | PSN | a3db80f8-5026-4954-aef5-dbf14c8c1b16 | 1 |
| 748797 | inert 1 MG Oral Tablet | PSN | 6c095eec-8d92-4b07-8f9e-84bb8c9bc3f8 | 1 |
| 748797 | inert 1 MG Oral Tablet | PSN | a3db80f8-5026-4954-aef5-dbf14c8c1b16 | 1 |
| 310230 | ethinyl estradiol 0.03 MG / levonorgestrel 0.05 MG Oral Tablet | SCD | 6c095eec-8d92-4b07-8f9e-84bb8c9bc3f8 | 1 |
| 310230 | ethinyl estradiol 0.03 MG / levonorgestrel 0.05 MG Oral Tablet | SCD | a3db80f8-5026-4954-aef5-dbf14c8c1b16 | 1 |
| 348804 | ethinyl estradiol 0.03 MG / levonorgestrel 0.125 MG Oral Tablet | SCD | 6c095eec-8d92-4b07-8f9e-84bb8c9bc3f8 | 1 |
| 348804 | ethinyl estradiol 0.03 MG / levonorgestrel 0.125 MG Oral Tablet | SCD | a3db80f8-5026-4954-aef5-dbf14c8c1b16 | 1 |
| 348805 | ethinyl estradiol 0.04 MG / levonorgestrel 0.075 MG Oral Tablet | SCD | 6c095eec-8d92-4b07-8f9e-84bb8c9bc3f8 | 1 |
| 348805 | ethinyl estradiol 0.04 MG / levonorgestrel 0.075 MG Oral Tablet | SCD | a3db80f8-5026-4954-aef5-dbf14c8c1b16 | 1 |
| 748797 | inert ingredients 1 MG Oral Tablet | SCD | a3db80f8-5026-4954-aef5-dbf14c8c1b16 | 1 |
| 748797 | inert ingredients 1 MG Oral Tablet | SCD | 6c095eec-8d92-4b07-8f9e-84bb8c9bc3f8 | 1 |
| 761977 | Enpresse 28 Day Pack | SY | a3db80f8-5026-4954-aef5-dbf14c8c1b16 | 1 |
| 761977 | Enpresse 28 Day Pack | SY | 6c095eec-8d92-4b07-8f9e-84bb8c9bc3f8 | 1 |
| 348804 | ethinyl estradiol 30 MCG / levonorgestrel 125 MCG Oral Tablet | SY | a3db80f8-5026-4954-aef5-dbf14c8c1b16 | 1 |
| 348804 | ethinyl estradiol 30 MCG / levonorgestrel 125 MCG Oral Tablet | SY | 6c095eec-8d92-4b07-8f9e-84bb8c9bc3f8 | 1 |
| 348805 | ethinyl estradiol 40 MCG / levonorgestrel 75 MCG Oral Tablet | SY | a3db80f8-5026-4954-aef5-dbf14c8c1b16 | 1 |
| 348805 | ethinyl estradiol 40 MCG / levonorgestrel 75 MCG Oral Tablet | SY | 6c095eec-8d92-4b07-8f9e-84bb8c9bc3f8 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0555-9047-58 | 00555904758 | 6 POUCH in 1 CARTON (0555-9047-58) > 1 BLISTER PACK in 1 POUCH > 1 KIT in 1 BLISTER PACK | 6 pouch | 2002-06-27 | 0000-00-00 | No | No | Current |