Nortriptyline Hydrochloride
- Product NDC
- 60760-811
- Requested package NDC
- 60760-811-30
- 11-digit product format
- 607600811
- Labeler code
- 60760
- Product ID
- 60760-811_7aca25ab-0948-371b-e053-2a91aa0a0fc0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nortriptyline Hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- St. Mary's Medical Park Pharmacy
- Application
- ANDA075520
- Marketing category
- ANDA
- Marketing start
- 2017-03-16
- 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
- 2020-12-31
- 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 | 60760-811 | 60760-811-30 | D | Discontinued by firm | 2026-08-03 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A075520-001 | NORTRIPTYLINE HYDROCHLORIDE | NORTRIPTYLINE HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | AB | 2000-05-08 | |
| A075520-002 | NORTRIPTYLINE HYDROCHLORIDE | NORTRIPTYLINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | 2000-05-08 | |
| A075520-003 | NORTRIPTYLINE HYDROCHLORIDE | NORTRIPTYLINE HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | AB | 2000-05-08 | |
| A075520-004 | NORTRIPTYLINE HYDROCHLORIDE | NORTRIPTYLINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB | 2000-05-08 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A075520-001 | AB |
| A075520-002 | AB |
| A075520-003 | AB |
| A075520-004 | 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 | A075520-001 | NORTRIPTYLINE HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | AB | 2000-05-08 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A075520-002 | NORTRIPTYLINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | 2000-05-08 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A075520-003 | NORTRIPTYLINE HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | AB | 2000-05-08 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A075520-004 | NORTRIPTYLINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB | 2000-05-08 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075520-001 | NORTRIPTYLINE HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | AB | 2000-05-08 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075520-002 | NORTRIPTYLINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | 2000-05-08 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075520-003 | NORTRIPTYLINE HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | AB | 2000-05-08 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075520-004 | NORTRIPTYLINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB | 2000-05-08 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075520-001 | NORTRIPTYLINE HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | AB | 2000-05-08 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075520-002 | NORTRIPTYLINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | 2000-05-08 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075520-003 | NORTRIPTYLINE HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | AB | 2000-05-08 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075520-004 | NORTRIPTYLINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB | 2000-05-08 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075520-001 | NORTRIPTYLINE HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | AB | 2000-05-08 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075520-002 | NORTRIPTYLINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | 2000-05-08 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075520-003 | NORTRIPTYLINE HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | AB | 2000-05-08 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075520-004 | NORTRIPTYLINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB | 2000-05-08 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075520-001 | NORTRIPTYLINE HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | AB | 2000-05-08 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075520-002 | NORTRIPTYLINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | 2000-05-08 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075520-003 | NORTRIPTYLINE HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | AB | 2000-05-08 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075520-004 | NORTRIPTYLINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB | 2000-05-08 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075520-001 | NORTRIPTYLINE HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | AB | 2000-05-08 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075520-002 | NORTRIPTYLINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | 2000-05-08 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075520-003 | NORTRIPTYLINE HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | AB | 2000-05-08 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075520-004 | NORTRIPTYLINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB | 2000-05-08 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075520-001 | NORTRIPTYLINE HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | AB | 2000-05-08 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075520-002 | NORTRIPTYLINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | 2000-05-08 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075520-003 | NORTRIPTYLINE HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | AB | 2000-05-08 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075520-004 | NORTRIPTYLINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB | 2000-05-08 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075520-001 | NORTRIPTYLINE HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | AB | 2000-05-08 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075520-002 | NORTRIPTYLINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | 2000-05-08 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075520-003 | NORTRIPTYLINE HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | AB | 2000-05-08 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075520-004 | NORTRIPTYLINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB | 2000-05-08 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075520-001 | NORTRIPTYLINE HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | AB | 2000-05-08 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075520-002 | NORTRIPTYLINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | 2000-05-08 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075520-003 | NORTRIPTYLINE HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | AB | 2000-05-08 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075520-004 | NORTRIPTYLINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB | 2000-05-08 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A075520-001 | NORTRIPTYLINE HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | AB | 2000-05-08 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A075520-002 | NORTRIPTYLINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | 2000-05-08 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A075520-003 | NORTRIPTYLINE HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | AB | 2000-05-08 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A075520-004 | NORTRIPTYLINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB | 2000-05-08 | 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 | A075520-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A075520-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A075520-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A075520-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075520-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075520-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075520-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075520-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A075520-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A075520-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A075520-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A075520-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075520-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075520-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075520-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075520-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075520-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075520-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075520-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075520-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075520-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075520-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075520-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075520-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075520-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075520-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075520-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075520-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075520-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075520-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075520-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075520-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075520-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075520-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075520-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075520-004 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A075520-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A075520-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A075520-003 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A075520-004 | AB | 1 | d06236e962d9… |
DailyMed Dashboard NDC Coverage#
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 | Sun Pharmaceutical Industries, Inc. | aee2c1a1-d848-4c3b-8c6d-8a4f6ce94c28 | 2026-07-15 | Boxed warning, Warnings, Adverse reactions | 075520 ANDA075520 |
| Nortriptyline Hydrochloride | NORTRIPTYLINE HYDROCHLORIDE | Northwind Health Company, LLC | dae3314f-3128-787f-e053-2995a90aff19 | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | 075520 ANDA075520 |
| Nortriptyline Hydrochloride | NORTRIPTYLINE HYDROCHLORIDE | Northwind Health Company, LLC | 09a54dbd-6bde-3083-e063-6394a90a5297 | 2025-12-26 | Boxed warning, Warnings, Adverse reactions | 075520 ANDA075520 |
| Nortriptyline Hydrochloride | NORTRIPTYLINE HYDROCHLORIDE | NuCare Pharmaceuticals, Inc. | 51778813-0ec1-6b4f-e054-00144ff8d46c | 2024-07-19 | Boxed warning, Warnings, Adverse reactions | 075520 ANDA075520 |
| Nortriptyline Hydrochloride | NORTRIPTYLINE HYDROCHLORIDE | A-S Medication Solutions | 53346b9c-40a1-4b5b-8df0-0b393661fb85 | 2024-02-12 | Boxed warning, Warnings, Adverse reactions | 075520 ANDA075520 |
| NORTRIPTYLINE HYDROCHLORIDE | NORTRIPTYLINE HYDROCHLORIDE | DIRECT RX | 45884cad-4a2d-44f4-93bd-16b130daf32d | 2024-01-09 | Boxed warning, Warnings, Adverse reactions | 075520 ANDA075520 |
| Nortriptyline Hydrochloride | NORTRIPTYLINE HYDROCHLORIDE | Bryant Ranch Prepack | cb4d1a69-60ae-4fdc-8af8-059959cf7265 | 2023-10-24 | Boxed warning, Warnings, Adverse reactions | 075520 ANDA075520 |
| Nortriptyline Hydrochloride | NORTRIPTYLINE HYDROCHLORIDE | Proficient Rx LP | 70921f99-1f25-4a8c-8269-6d5d26be7a63 | 2023-01-01 | Boxed warning, Warnings, Adverse reactions | 075520 ANDA075520 |
| Nortriptyline Hydrochloride | NORTRIPTYLINE HYDROCHLORIDE | Proficient Rx LP | 59a65e6f-b812-4195-b85b-c412fb902c93 | 2022-07-01 | Boxed warning, Warnings, Adverse reactions | 075520 ANDA075520 |
| Nortriptyline Hydrochloride | NORTRIPTYLINE HYDROCHLORIDE | Proficient Rx LP | c5b1ef5e-9681-426a-abf6-60d9c28d92a0 | 2022-06-01 | Boxed warning, Warnings, Adverse reactions | 075520 ANDA075520 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 60760-811-30 | 60760081130 | 30 CAPSULE in 1 BOTTLE, PLASTIC (60760-811-30) | 30 capsule | 2017-03-16 | 0000-00-00 | No | No | Current |