Nortriptyline Hydrochloride
- Product NDC
- 33261-348
- 11-digit product format
- 332610348
- Labeler code
- 33261
- Product ID
- 33261-348_7f8fad0a-267b-4284-9de3-14ddd77d9ac0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nortriptyline Hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Aidarex Pharmaceuticals LLC
- Application
- ANDA074132
- Marketing category
- ANDA
- Marketing start
- 1995-04-06
- Marketing end
- 0000-00-00
- Substance
- NORTRIPTYLINE HYDROCHLORIDE
- Active strength
- 25 mg/1
- Pharmacologic classes
- Tricyclic Antidepressant [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| de76de11-1019-6138-2d8a-16fa566ae22a | Product name | 2 | 20241009 |
| 53e88688-54e1-9681-22b8-e499bd715088 | Product name | 2 | 20210729 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 33261-348-02 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-75fd-f424-e053-dadaa90a57ce | NORTRIPTYLINE HYDROCHLORIDE CAPSULES USP 0810 0811 0812 0813 Rx only |
| 33261-348-30 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-75fd-f424-e053-dadaa90a57ce | NORTRIPTYLINE HYDROCHLORIDE CAPSULES USP 0810 0811 0812 0813 Rx only |
| 33261-348-60 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-75fd-f424-e053-dadaa90a57ce | NORTRIPTYLINE HYDROCHLORIDE CAPSULES USP 0810 0811 0812 0813 Rx only |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 33261-348-02 | Nortriptyline Hydrochloride | 120 in 1 BOTTLE, PLASTIC | CAPSULE | 120 | 1 | |
| 33261-348-30 | Nortriptyline Hydrochloride | 30 in 1 BOTTLE, PLASTIC | CAPSULE | 30 | 1 | |
| 33261-348-60 | Nortriptyline Hydrochloride | 60 in 1 BOTTLE, PLASTIC | CAPSULE | 60 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 33261-348-02 | EA - Each | 33261-348 | 219523f8-6f38-4d0f-ba11-02baa1ffa24a | 1 | 2015-10-02 |
| 33261-348-30 | EA - Each | 33261-348 | 1d337a61-df46-4d0d-a394-7a012eb9d5f8 | 1 | 2015-10-02 |
| 33261-348-60 | EA - Each | 33261-348 | bd745e77-744c-4652-ad7e-99bc830685dd | 1 | 2015-10-02 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 317136 | nortriptyline HCl 25 MG Oral Capsule | PSN | 79d0c09a-8557-44a2-bb87-2ddc496edc1b | 1 |
| 198046 | nortriptyline HCl 50 MG Oral Capsule | PSN | 79d0c09a-8557-44a2-bb87-2ddc496edc1b | 1 |
| 198047 | nortriptyline HCl 75 MG Oral Capsule | PSN | 79d0c09a-8557-44a2-bb87-2ddc496edc1b | 1 |
| 317136 | nortriptyline 25 MG Oral Capsule | SCD | 79d0c09a-8557-44a2-bb87-2ddc496edc1b | 1 |
| 198046 | nortriptyline 50 MG Oral Capsule | SCD | 79d0c09a-8557-44a2-bb87-2ddc496edc1b | 1 |
| 198047 | nortriptyline 75 MG Oral Capsule | SCD | 79d0c09a-8557-44a2-bb87-2ddc496edc1b | 1 |
| 317136 | nortriptyline (as nortriptyline HCl) 25 MG Oral Capsule | SY | 79d0c09a-8557-44a2-bb87-2ddc496edc1b | 1 |
| 198046 | nortriptyline (as nortriptyline HCl) 50 MG Oral Capsule | SY | 79d0c09a-8557-44a2-bb87-2ddc496edc1b | 1 |
| 198047 | nortriptyline (as nortriptyline HCl) 75 MG Oral Capsule | SY | 79d0c09a-8557-44a2-bb87-2ddc496edc1b | 1 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 33261-348-02 | 33261034802 | 120 in 1 BOTTLE, PLASTIC | Historical |
| 33261-348-30 | 33261034830 | 30 in 1 BOTTLE, PLASTIC | Historical |
| 33261-348-60 | 33261034860 | 60 in 1 BOTTLE, PLASTIC | Historical |