Nortrel
- Product NDC
- 0555-9009
- 11-digit product format
- 005559009
- Labeler code
- 0555
- Product ID
- 0555-9009_9ac007e4-792d-4122-8daf-456dea28f82f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Norethindrone and Ethinyl Estradiol
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Teva Pharmaceuticals USA, Inc.
- Application
- ANDA072693
- Marketing category
- ANDA
- Marketing start
- 2001-06-13
- Substance
- ETHINYL ESTRADIOL; NORETHINDRONE
- Active strength
- .035; 1 mg/1; mg/1
- Pharmacologic classes
- Estrogen Receptor Agonists [MoA], Estrogen [EPC], Progesterone Congeners [CS], Progestin [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Nortrel
- Brand name suffix
- 21 Day
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ETHINYL ESTRADIOL | .035 mg/1 |
| NORETHINDRONE | 1 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 423D2T571U, T18F433X4S |
| Rxcui | 310463, 312033, 748797, 749858, 749869, 749879, 751868, 751870, 751871 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0555-9009-42 | Nortrel21 Day | 3 in 1 CARTON | TABLET | 3 | 16 | |
| 0555-9009-80 | Nortrel21 Day | 1 in 1 POUCH | TABLET | 1 | 16 | |
| 0555-9009-80 | Nortrel21 Day | 21 in 1 BLISTER PACK | TABLET | 21 | 16 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0555-9009-42 | EA - Each | 0555-9009 | 7a751c67-9f9a-4627-a39c-f78a943ca1ca | 1 | 2012-07-24 |
| 0555-9009-57 | EA - Each | 0555-9009 | 718feefd-6a24-4fe0-ac95-7672b16426bd | 1 | 2012-07-24 |
| 0555-9009-80 | EA - Each | 0555-9009 | 03673668-0331-404c-af7c-c20c815c294b | 1 | 2017-04-05 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0555-9009 | NORTREL 21 DAY (NORETHINDRONE AND ETHINYL ESTRADIOL) TABLET NORTREL 28 DAY (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [TEVA PHARMACEUTICALS USA, INC.] | 15 | Current NDC, Legacy NDC, 3 package rows | 20250316_140c50d6-c931-423a-9aa0-526eae7ab93c.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 751868 | {21 (ethinyl estradiol 0.035 MG / norethindrone 0.5 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [Nortrel 0.5/35 28 Day] | BPCK | 140c50d6-c931-423a-9aa0-526eae7ab93c | 16 |
| 751871 | {21 (ethinyl estradiol 0.035 MG / norethindrone 1 MG Oral Tablet) } Pack [Nortrel 1/35 21 Day] | BPCK | 140c50d6-c931-423a-9aa0-526eae7ab93c | 16 |
| 751870 | {21 (ethinyl estradiol 0.035 MG / norethindrone 1 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [Nortrel 1/35 28 Day] | BPCK | 140c50d6-c931-423a-9aa0-526eae7ab93c | 16 |
| 749879 | {21 (ethinyl estradiol 0.035 MG / norethindrone 0.5 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack | GPCK | 140c50d6-c931-423a-9aa0-526eae7ab93c | 16 |
| 749869 | {21 (ethinyl estradiol 0.035 MG / norethindrone 1 MG Oral Tablet) } Pack | GPCK | 140c50d6-c931-423a-9aa0-526eae7ab93c | 16 |
| 749858 | {21 (ethinyl estradiol 0.035 MG / norethindrone 1 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack | GPCK | 140c50d6-c931-423a-9aa0-526eae7ab93c | 16 |
| 749869 | Eth estra-Noreth 0.0.35-1 MG (21) Oral Tablet 21 Day Pack | PSN | 140c50d6-c931-423a-9aa0-526eae7ab93c | 16 |
| 749879 | Eth estra-Noreth 0.035-0.5 MG (21) Oral Tablet / Inert 1 MG (7) Oral Tablet 28 Day Pack | PSN | 140c50d6-c931-423a-9aa0-526eae7ab93c | 16 |
| 749858 | Eth estra-Noreth 0.035-1 MG (21) Oral Tablet / Inert 1 MG (7) Oral Tablet 28 Day Pack | PSN | 140c50d6-c931-423a-9aa0-526eae7ab93c | 16 |
| 748797 | inert 1 MG Oral Tablet | PSN | 140c50d6-c931-423a-9aa0-526eae7ab93c | 16 |
| 310463 | norethindrone 0.5 MG / ethinyl estradiol 0.035 MG Oral Tablet | PSN | 140c50d6-c931-423a-9aa0-526eae7ab93c | 16 |
| 312033 | norethindrone acetate 1 MG / ethinyl estradiol 35 MCG Oral Tablet | PSN | 140c50d6-c931-423a-9aa0-526eae7ab93c | 16 |
| 751868 | Nortrel 0.5/35 28 Day Pack | PSN | 140c50d6-c931-423a-9aa0-526eae7ab93c | 16 |
| 751871 | Nortrel 1/35 21 Day Pack | PSN | 140c50d6-c931-423a-9aa0-526eae7ab93c | 16 |
| 751870 | Nortrel 1/35 28 Day Pack | PSN | 140c50d6-c931-423a-9aa0-526eae7ab93c | 16 |
| 310463 | ethinyl estradiol 0.035 MG / norethindrone 0.5 MG Oral Tablet | SCD | 140c50d6-c931-423a-9aa0-526eae7ab93c | 16 |
| 312033 | ethinyl estradiol 0.035 MG / norethindrone 1 MG Oral Tablet | SCD | 140c50d6-c931-423a-9aa0-526eae7ab93c | 16 |
| 748797 | inert ingredients 1 MG Oral Tablet | SCD | 140c50d6-c931-423a-9aa0-526eae7ab93c | 16 |
| 310463 | ethinyl estradiol 35 MCG / norethindrone 0.5 MG Oral Tablet | SY | 140c50d6-c931-423a-9aa0-526eae7ab93c | 16 |
| 312033 | ethinyl estradiol 35 MCG / norethindrone 1 MG Oral Tablet | SY | 140c50d6-c931-423a-9aa0-526eae7ab93c | 16 |
| 751868 | Nortrel 0.5/35 28 Day Pack | SY | 140c50d6-c931-423a-9aa0-526eae7ab93c | 16 |
| 751871 | Nortrel 1/35 21 Day Pack | SY | 140c50d6-c931-423a-9aa0-526eae7ab93c | 16 |
| 751870 | Nortrel 1/35 28 Day Pack | SY | 140c50d6-c931-423a-9aa0-526eae7ab93c | 16 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0555-9009-42 | 00555900942 | 3 POUCH in 1 CARTON (0555-9009-42) / 1 BLISTER PACK in 1 POUCH (0555-9009-80) / 21 TABLET in 1 BLISTER PACK | 3 pouch | 2001-06-13 | 0000-00-00 | No | No | Current |
| 0555-9009-80 | 00555900980 | 1 in 1 POUCH | Historical |