Nortriptyline Hydrochloride
- Product NDC
- 71335-0065
- Requested package NDC
- 71335-0065-2
- 11-digit product format
- 713350065
- Labeler code
- 71335
- Product ID
- 71335-0065_44dcf81d-9d13-4631-9611-3394084f8c05
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nortriptyline Hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA074132
- Marketing category
- ANDA
- Marketing start
- 1995-04-05
- Substance
- NORTRIPTYLINE HYDROCHLORIDE
- Active strength
- 75 mg/1
- Pharmacologic classes
- Tricyclic Antidepressant [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
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 | Snapshot | Source SHA-256 |
|---|---|---|
| 2025-08-27 00:01 UTC · source 2025-08-26 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | 834df4deac94… | adcc014656a3… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | 1332a3947898… | d4bfe170f9cd… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A074132-001 | NORTRIPTYLINE HYDROCHLORIDE | NORTRIPTYLINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB | 1995-03-27 | |
| A074132-002 | NORTRIPTYLINE HYDROCHLORIDE | NORTRIPTYLINE HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | AB | 1995-03-27 | |
| A074132-003 | NORTRIPTYLINE HYDROCHLORIDE | NORTRIPTYLINE HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | AB | 1995-03-27 | |
| A074132-004 | NORTRIPTYLINE HYDROCHLORIDE | NORTRIPTYLINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | RS | 1995-03-27 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A074132-001 | AB |
| A074132-002 | AB |
| A074132-003 | AB |
| A074132-004 | 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 | A074132-001 | NORTRIPTYLINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB | 1995-03-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A074132-002 | NORTRIPTYLINE HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | AB | 1995-03-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A074132-003 | NORTRIPTYLINE HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | AB | 1995-03-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A074132-004 | NORTRIPTYLINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | RS | 1995-03-27 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A074132-001 | NORTRIPTYLINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB | 1995-03-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A074132-002 | NORTRIPTYLINE HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | AB | 1995-03-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A074132-003 | NORTRIPTYLINE HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | AB | 1995-03-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A074132-004 | NORTRIPTYLINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | RS | 1995-03-27 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A074132-001 | NORTRIPTYLINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB | 1995-03-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A074132-002 | NORTRIPTYLINE HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | AB | 1995-03-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A074132-003 | NORTRIPTYLINE HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | AB | 1995-03-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A074132-004 | NORTRIPTYLINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | RS | 1995-03-27 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A074132-001 | NORTRIPTYLINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB | 1995-03-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A074132-002 | NORTRIPTYLINE HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | AB | 1995-03-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A074132-003 | NORTRIPTYLINE HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | AB | 1995-03-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A074132-004 | NORTRIPTYLINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | RS | 1995-03-27 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A074132-001 | NORTRIPTYLINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB | 1995-03-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A074132-002 | NORTRIPTYLINE HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | AB | 1995-03-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A074132-003 | NORTRIPTYLINE HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | AB | 1995-03-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A074132-004 | NORTRIPTYLINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | RS | 1995-03-27 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A074132-001 | NORTRIPTYLINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB | 1995-03-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A074132-002 | NORTRIPTYLINE HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | AB | 1995-03-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A074132-003 | NORTRIPTYLINE HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | AB | 1995-03-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A074132-004 | NORTRIPTYLINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | RS | 1995-03-27 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A074132-001 | NORTRIPTYLINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB | 1995-03-27 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A074132-002 | NORTRIPTYLINE HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | AB | 1995-03-27 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A074132-003 | NORTRIPTYLINE HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | AB | 1995-03-27 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A074132-004 | NORTRIPTYLINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | 1995-03-27 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A074132-001 | NORTRIPTYLINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB | 1995-03-27 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A074132-002 | NORTRIPTYLINE HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | AB | 1995-03-27 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A074132-003 | NORTRIPTYLINE HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | AB | 1995-03-27 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A074132-004 | NORTRIPTYLINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | 1995-03-27 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A074132-001 | NORTRIPTYLINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB | 1995-03-27 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A074132-002 | NORTRIPTYLINE HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | AB | 1995-03-27 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A074132-003 | NORTRIPTYLINE HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | AB | 1995-03-27 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A074132-004 | NORTRIPTYLINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | 1995-03-27 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A074132-001 | NORTRIPTYLINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB | 1995-03-27 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A074132-002 | NORTRIPTYLINE HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | AB | 1995-03-27 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A074132-003 | NORTRIPTYLINE HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | AB | 1995-03-27 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A074132-004 | NORTRIPTYLINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | 1995-03-27 | 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 | A074132-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A074132-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A074132-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A074132-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A074132-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A074132-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A074132-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A074132-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A074132-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A074132-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A074132-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A074132-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A074132-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A074132-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A074132-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A074132-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A074132-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A074132-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A074132-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A074132-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A074132-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A074132-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A074132-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A074132-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A074132-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A074132-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A074132-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A074132-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A074132-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A074132-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A074132-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A074132-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A074132-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A074132-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A074132-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A074132-004 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A074132-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A074132-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A074132-003 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A074132-004 | AB | 1 | d06236e962d9… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Nortriptyline Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| NORTRIPTYLINE HYDROCHLORIDE | 75 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 00FN6IH15D | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 198047 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 962f3f54-0556-4509-a231-ca62cb01bec8 | Available on FDA.report |
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 | Related label |
|---|---|---|
| 71335-0065-1 | 2025-11-17 | Nortriptyline Hydrochloride Capsules, USP Rx only |
| 71335-0065-2 | 2025-11-17 | Nortriptyline Hydrochloride Capsules, USP Rx only |
| 71335-0065-3 | 2025-11-17 | Nortriptyline Hydrochloride Capsules, USP Rx only |
| 71335-0065-4 | 2025-11-17 | Nortriptyline Hydrochloride Capsules, USP Rx only |
| 71335-0065-1 | 2024-01-30 | Nortriptyline Hydrochloride Capsules, USP Rx only |
| 71335-0065-2 | 2024-01-30 | Nortriptyline Hydrochloride Capsules, USP Rx only |
| 71335-0065-3 | 2024-01-30 | Nortriptyline Hydrochloride Capsules, USP Rx only |
| 71335-0065-4 | 2024-01-30 | Nortriptyline Hydrochloride Capsules, USP Rx only |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 71335-0065-1 | Nortriptyline Hydrochloride | 30 in 1 BOTTLE | CAPSULE | 30 | 6 | |
| 71335-0065-2 | Nortriptyline Hydrochloride | 60 in 1 BOTTLE | CAPSULE | 60 | 6 | |
| 71335-0065-3 | Nortriptyline Hydrochloride | 90 in 1 BOTTLE | CAPSULE | 90 | 6 | |
| 71335-0065-4 | Nortriptyline Hydrochloride | 28 in 1 BOTTLE | CAPSULE | 28 | 6 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 71335-0065-1 | EA - Each | 71335-0065 | 4f3947f0-ad1f-40e1-b864-a6c68e529748 | 1 | 2018-03-08 |
| 71335-0065-2 | EA - Each | 71335-0065 | aaad9f1a-1837-4c36-8f1d-f32ff1385694 | 1 | 2018-03-08 |
| 71335-0065-3 | EA - Each | 71335-0065 | cc762333-cdb5-4979-a5be-684dd4f2be29 | 1 | 2018-03-08 |
| 71335-0065-4 | EA - Each | 71335-0065 | dbea88eb-50a5-4f10-83aa-77e4c2b88fb5 | 1 | 2018-03-08 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 71335-0065 | NORTRIPTYLINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK] | 5 | Current NDC, Legacy NDC, 4 package rows | 20220122_962f3f54-0556-4509-a231-ca62cb01bec8.zip |
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 | REMEDYREPACK INC. | dd1f4d6f-14cc-44c0-b9d3-bb3d17b557fa | 2026-06-12 | Boxed warning, Warnings, Adverse reactions | 074132 ANDA074132 |
| Nortriptyline Hydrochloride | NORTRIPTYLINE HYDROCHLORIDE | REMEDYREPACK INC. | 522d0cd8-d84d-4961-a525-4527fce44c3c | 2026-06-10 | Boxed warning, Warnings, Adverse reactions | 074132 ANDA074132 |
| Nortriptyline Hydrochloride | NORTRIPTYLINE HYDROCHLORIDE | A-S Medication Solutions | a2cf7783-7019-49ea-ab55-796674d94546 | 2026-03-24 | Boxed warning, Warnings, Adverse reactions | 074132 ANDA074132 |
| Nortriptyline Hydrochloride | NORTRIPTYLINE HYDROCHLORIDE | Bryant Ranch Prepack | 8eef261f-5c78-a88f-37c4-46e6b0e0f0ee | 2026-03-10 | Boxed warning, Warnings, Adverse reactions | 074132 ANDA074132 |
| Nortriptyline Hydrochloride | NORTRIPTYLINE HYDROCHLORIDE | Coupler LLC | 4c21abdb-f3e9-9037-e063-6294a90af4b4 | 2026-03-03 | Boxed warning, Warnings, Adverse reactions | 074132 ANDA074132 |
| NORTRIPTYLINE HYDROCHLORIDE | NORTRIPTYLINE HYDROCHLORIDE | Direct Rx | 017f7717-e160-4142-9a5a-1a2bd9776707 | 2026-01-13 | Boxed warning, Warnings, Adverse reactions | 074132 ANDA074132 |
| Nortriptyline Hydrochloride | NORTRIPTYLINE HYDROCHLORIDE | American Health Packaging | d111c36d-98ed-4f0d-97ea-86fe9048deee | 2025-12-01 | Boxed warning, Warnings, Adverse reactions | 074132 ANDA074132 |
| Nortriptyline Hydrochloride | NORTRIPTYLINE HYDROCHLORIDE | A-S Medication Solutions | 686d15d0-6434-42ec-8c78-f45d617d294c | 2025-12-01 | Boxed warning, Warnings, Adverse reactions | 074132 ANDA074132 |
| Nortriptyline Hydrochloride | NORTRIPTYLINE HYDROCHLORIDE | Bryant Ranch Prepack | 962f3f54-0556-4509-a231-ca62cb01bec8 | 2025-11-17 | Boxed warning, Warnings, Adverse reactions | 074132 ANDA074132 71335-0065-2 71335-0065 71335006502 |
| Nortriptyline Hydrochloride | NORTRIPTYLINE HYDROCHLORIDE | Bryant Ranch Prepack | 43a81887-42b8-43b5-b58a-3f3df2e9949b | 2025-11-07 | Boxed warning, Warnings, Adverse reactions | 074132 ANDA074132 |
| Nortriptyline Hydrochloride | NORTRIPTYLINE HYDROCHLORIDE | Teva Pharmaceuticals USA, Inc. | b58d473a-b19f-4d2a-b1ae-dd398d7a29e1 | 2025-09-30 | Boxed warning, Warnings, Adverse reactions | 074132 ANDA074132 |
| Nortriptyline Hydrochloride | NORTRIPTYLINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | af950b46-07df-4de6-a221-d3d7059b87a1 | 2025-08-28 | Boxed warning, Warnings, Adverse reactions | 074132 ANDA074132 |
| Nortriptyline Hydrochloride | NORTRIPTYLINE HYDROCHLORIDE | Proficient Rx LP | e047f990-c374-4f8f-8583-c615f92545e2 | 2024-10-01 | Boxed warning, Warnings, Adverse reactions | 074132 ANDA074132 |
| Nortriptyline Hydrochloride | NORTRIPTYLINE HYDROCHLORIDE | Proficient Rx LP | 2f9fc7a0-163a-4a05-84a7-7999a41ecb1f | 2024-10-01 | Boxed warning, Warnings, Adverse reactions | 074132 ANDA074132 |
| Nortriptyline Hydrochloride | NORTRIPTYLINE HYDROCHLORIDE | Proficient Rx LP | b387ba49-fd3f-4488-86e8-9b81e85ab232 | 2024-10-01 | Boxed warning, Warnings, Adverse reactions | 074132 ANDA074132 |
| Nortriptyline Hydrochloride | NORTRIPTYLINE HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | f1868790-c70b-4979-974d-3ce0ffe99e36 | 2024-02-01 | Boxed warning, Warnings, Adverse reactions | 074132 ANDA074132 |
| Nortriptyline Hydrochloride | NORTRIPTYLINE HYDROCHLORIDE | Proficient Rx LP | 30263e15-de21-4db4-aceb-59d619909e82 | 2023-03-01 | Boxed warning, Warnings, Adverse reactions | 074132 ANDA074132 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 198047 | nortriptyline HCl 75 MG Oral Capsule | PSN | 962f3f54-0556-4509-a231-ca62cb01bec8 | 6 |
| 198047 | nortriptyline 75 MG Oral Capsule | SCD | 962f3f54-0556-4509-a231-ca62cb01bec8 | 6 |
| 198047 | nortriptyline (as nortriptyline HCl) 75 MG Oral Capsule | SY | 962f3f54-0556-4509-a231-ca62cb01bec8 | 6 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 71335-0065-2 | 71335006502 | 60 CAPSULE in 1 BOTTLE (71335-0065-2) | 60 capsule | 2021-12-27 | 0000-00-00 | No | No | Current |