Nortriptyline Hydrochloride
- Product NDC
- 70934-578
- Requested package NDC
- 70934-578-30
- 11-digit product format
- 709340578
- Labeler code
- 70934
- Product ID
- 70934-578_abaf4a1f-4edc-81a3-e053-2995a90a9623
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nortriptyline Hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Denton Pharma, Inc. dba Northwind Pharmaceuticals
- Application
- ANDA073556
- Marketing category
- ANDA
- Marketing start
- 2020-03-03
- 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
- 2021-12-31
- 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 package | package | 70934-578 | 70934-578-30 | D | Discontinued by firm | 2026-08-03 |
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 | Code | Status | Snapshot | Source SHA-256 |
|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | D | Discontinued by firm | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | D | Discontinued by firm | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | D | Discontinued by firm | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | D | Discontinued by firm | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | D | Discontinued by firm | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | D | Discontinued by firm | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | D | Discontinued by firm | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | D | Discontinued by firm | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | D | Discontinued by firm | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | D | Discontinued by firm | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | D | Discontinued by firm | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | D | Discontinued by firm | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2022-08-30 03:57 UTC · source 2022-08-29 | I | Inactivated by FDA | fb8cb913e6d1… | eb8c232b6be0… |
| 2022-04-09 23:13 UTC · source 2022-04-08 | I | Inactivated by FDA | 86f5da6cb304… | a595104c45d7… |
| 2022-04-04 05:40 UTC · source 2022-04-01 | I | Inactivated by FDA | bd6a592717d7… | 303034d00443… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A073556-001 | NORTRIPTYLINE HYDROCHLORIDE | NORTRIPTYLINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | 1992-03-30 | |
| A073556-002 | NORTRIPTYLINE HYDROCHLORIDE | NORTRIPTYLINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB | 1992-03-30 | |
| A073556-003 | NORTRIPTYLINE HYDROCHLORIDE | NORTRIPTYLINE HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | AB | 1992-03-30 | |
| A073556-004 | NORTRIPTYLINE HYDROCHLORIDE | NORTRIPTYLINE HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | AB | 1992-03-30 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A073556-001 | AB |
| A073556-002 | AB |
| A073556-003 | AB |
| A073556-004 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A073556-001 | NORTRIPTYLINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | 1992-03-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A073556-002 | NORTRIPTYLINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB | 1992-03-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A073556-003 | NORTRIPTYLINE HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | AB | 1992-03-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A073556-004 | NORTRIPTYLINE HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | AB | 1992-03-30 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A073556-001 | NORTRIPTYLINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | 1992-03-30 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A073556-002 | NORTRIPTYLINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB | 1992-03-30 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A073556-003 | NORTRIPTYLINE HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | AB | 1992-03-30 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A073556-004 | NORTRIPTYLINE HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | AB | 1992-03-30 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A073556-001 | NORTRIPTYLINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | 1992-03-30 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A073556-002 | NORTRIPTYLINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB | 1992-03-30 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A073556-003 | NORTRIPTYLINE HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | AB | 1992-03-30 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A073556-004 | NORTRIPTYLINE HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | AB | 1992-03-30 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A073556-001 | NORTRIPTYLINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | 1992-03-30 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A073556-002 | NORTRIPTYLINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB | 1992-03-30 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A073556-003 | NORTRIPTYLINE HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | AB | 1992-03-30 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A073556-004 | NORTRIPTYLINE HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | AB | 1992-03-30 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A073556-001 | NORTRIPTYLINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | 1992-03-30 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A073556-002 | NORTRIPTYLINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB | 1992-03-30 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A073556-003 | NORTRIPTYLINE HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | AB | 1992-03-30 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A073556-004 | NORTRIPTYLINE HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | AB | 1992-03-30 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A073556-001 | NORTRIPTYLINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | 1992-03-30 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A073556-002 | NORTRIPTYLINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB | 1992-03-30 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A073556-003 | NORTRIPTYLINE HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | AB | 1992-03-30 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A073556-004 | NORTRIPTYLINE HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | AB | 1992-03-30 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A073556-001 | NORTRIPTYLINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | 1992-03-30 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A073556-002 | NORTRIPTYLINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB | 1992-03-30 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A073556-003 | NORTRIPTYLINE HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | AB | 1992-03-30 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A073556-004 | NORTRIPTYLINE HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | AB | 1992-03-30 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A073556-001 | NORTRIPTYLINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | 1992-03-30 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A073556-002 | NORTRIPTYLINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB | 1992-03-30 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A073556-003 | NORTRIPTYLINE HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | AB | 1992-03-30 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A073556-004 | NORTRIPTYLINE HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | AB | 1992-03-30 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A073556-001 | NORTRIPTYLINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | 1992-03-30 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A073556-002 | NORTRIPTYLINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB | 1992-03-30 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A073556-003 | NORTRIPTYLINE HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | AB | 1992-03-30 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A073556-004 | NORTRIPTYLINE HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | AB | 1992-03-30 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A073556-001 | NORTRIPTYLINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | 1992-03-30 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A073556-002 | NORTRIPTYLINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB | 1992-03-30 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A073556-003 | NORTRIPTYLINE HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | AB | 1992-03-30 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A073556-004 | NORTRIPTYLINE HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | AB | 1992-03-30 | d06236e962d9… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A073556-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A073556-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A073556-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A073556-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A073556-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A073556-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A073556-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A073556-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A073556-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A073556-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A073556-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A073556-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A073556-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A073556-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A073556-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A073556-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A073556-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A073556-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A073556-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A073556-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A073556-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A073556-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A073556-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A073556-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A073556-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A073556-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A073556-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A073556-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A073556-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A073556-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A073556-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A073556-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A073556-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A073556-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A073556-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A073556-004 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A073556-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A073556-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A073556-003 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A073556-004 | AB | 1 | d06236e962d9… |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 70934-578-30 | 2023-02-03 | C162847 | 48780-1 | d6a99b39-f9fd-a426-e053-dadaa90af4c2 | Nortriptyline Hydrochloride Capsules USP |
| 70934-578-30 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-f9fd-a426-e053-dadaa90af4c2 | Nortriptyline Hydrochloride Capsules USP |
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 |
|---|---|---|---|---|---|---|
| Nortriptyline Hydrochloride | NORTRIPTYLINE HYDROCHLORIDE | Proficient Rx LP | 1e32f284-a5b2-4ebf-9d9e-0e9a40b46ade | 2026-07-01 | Boxed warning, Warnings, Adverse reactions | 073556 ANDA073556 |
| Nortriptyline Hydrochloride | NORTRIPTYLINE HYDROCHLORIDE | St. Mary's Medical Park Pharmacy | 3c57301f-5128-295e-e063-6394a90ad99e | 2026-06-29 | Boxed warning, Warnings, Adverse reactions | 073556 ANDA073556 |
| Nortriptyline HCL | NORTRIPTYLINE HCL | Direct_rx | 1bcf2f7b-974f-54ad-e063-6394a90a28d9 | 2026-06-04 | Boxed warning, Warnings, Adverse reactions | 073556 ANDA073556 |
| Nortriptyline Hydrochloride | NORTRIPTYLINE HYDROCHLORIDE | REMEDYREPACK INC. | 27e96d6c-b311-45d2-b879-65c6a4efcfba | 2026-06-01 | Boxed warning, Warnings, Adverse reactions | 073556 ANDA073556 |
| Nortriptyline Hydrochloride | NORTRIPTYLINE HYDROCHLORIDE | ST. MARY'S MEDICAL PARK PHARMACY | 21770082-7a99-520d-e063-6394a90ab9cb | 2026-05-19 | Boxed warning, Warnings, Adverse reactions | 073556 ANDA073556 |
| Nortriptyline HCL | NORTRIPTYLINE HCL | Direct_rx | 1b55fd23-36f8-10e4-e063-6394a90aa49a | 2026-04-15 | Boxed warning, Warnings, Adverse reactions | 073556 ANDA073556 |
| Nortriptyline HCL | NORTRIPTYLINE HCL | Direct_rx | 1ba55931-5597-90ea-e063-6294a90a5a2f | 2026-03-17 | Boxed warning, Warnings, Adverse reactions | 073556 ANDA073556 |
| Nortriptyline Hydrochloride | NORTRIPTYLINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | ba4edb34-82ac-4c98-8abd-fd6176838c78 | 2025-10-16 | Boxed warning, Warnings, Adverse reactions | 073556 ANDA073556 |
| Nortriptyline Hydrochloride | NORTRIPTYLINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | dbb3cc4d-c36d-495d-b9fc-e5513b2f6b93 | 2025-10-14 | Boxed warning, Warnings, Adverse reactions | 073556 ANDA073556 |
| Nortriptyline Hydrochloride | NORTRIPTYLINE HYDROCHLORIDE | Bryant Ranch Prepack | 6b055ebf-ed9e-44c5-bc03-6b6480d14377 | 2025-10-13 | Boxed warning, Warnings, Adverse reactions | 073556 ANDA073556 |
| Nortriptyline Hydrochloride | NORTRIPTYLINE HYDROCHLORIDE | REMEDYREPACK INC. | 4852a754-2fc1-4c10-a414-dc8a1dfd66a2 | 2025-10-01 | Boxed warning, Warnings, Adverse reactions | 073556 ANDA073556 |
| Nortriptyline Hydrochloride | NORTRIPTYLINE HYDROCHLORIDE | REMEDYREPACK INC. | c7cce83f-9508-49de-a442-246ad18ddeda | 2025-09-25 | Boxed warning, Warnings, Adverse reactions | 073556 ANDA073556 |
| Nortriptyline Hydrochloride | NORTRIPTYLINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | f684e9c8-eca7-4e27-872d-c0adea19de9a | 2025-08-28 | Boxed warning, Warnings, Adverse reactions | 073556 ANDA073556 |
| Nortriptyline Hydrochloride | NORTRIPTYLINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 60763e7a-d22c-47d5-a260-f64bd4a4f654 | 2025-07-10 | Boxed warning, Warnings, Adverse reactions | 073556 ANDA073556 |
| Nortriptyline Hydrochloride | NORTRIPTYLINE HYDROCHLORIDE | Advanced Rx of Tennessee, LLC | 36b00c00-5fbd-c14b-e063-6294a90a49b7 | 2025-06-03 | Boxed warning, Warnings, Adverse reactions | 073556 ANDA073556 |
| Nortriptyline Hydrochloride | NORTRIPTYLINE HYDROCHLORIDE | Coupler LLC | 2fffe23d-37f8-34fe-e063-6294a90a7b6c | 2025-03-10 | Boxed warning, Warnings, Adverse reactions | 073556 ANDA073556 |
| Nortriptyline Hydrochloride | NORTRIPTYLINE HYDROCHLORIDE | Coupler LLC | 2ccb3fd0-53c9-6015-e063-6294a90a3fd6 | 2025-01-28 | Boxed warning, Warnings, Adverse reactions | 073556 ANDA073556 |
| Nortriptyline Hydrochloride | NORTRIPTYLINE HYDROCHLORIDE | Asclemed USA, Inc. | b02eb04a-83ee-45b0-b755-187fde2698c3 | 2025-01-27 | Boxed warning, Warnings, Adverse reactions | 073556 ANDA073556 |
| Nortriptyline Hydrochloride | NORTRIPTYLINE HYDROCHLORIDE | Coupler LLC | 2c92511f-0127-c74e-e063-6394a90a1214 | 2025-01-25 | Boxed warning, Warnings, Adverse reactions | 073556 ANDA073556 |
| Nortriptyline Hydrochloride | NORTRIPTYLINE HYDROCHLORIDE | Proficient Rx LP | 661ec73c-d893-446a-83c3-218b06889962 | 2024-09-01 | Boxed warning, Warnings, Adverse reactions | 073556 ANDA073556 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 70934-578-30 | 70934057830 | 30 CAPSULE in 1 BOTTLE, PLASTIC (70934-578-30) | 30 capsule | 2020-03-03 | 0000-00-00 | No | No | Current |