Nortriptyline Hydrochloride

Product NDC: 63629-3204
Requested package NDC: 63629-3204-5
11-digit product format: 636293204
Labeler code: 63629
Product ID: 63629-3204_7d1dd83e-d7a4-4349-bcc8-a3e05aad53af
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: 10 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.

Historic NDC status page 1 of 1 · 1 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	63629-3204	63629-3204-5	I	Inactivated by FDA		excluded / ndc_excluded.zip	`9bebd1f3094a…`	`5416666fcb17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
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#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
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.

Product history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
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#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
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 table
Ingredient	Strength
NORTRIPTYLINE HYDROCHLORIDE	10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
00FN6IH15D	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
198045	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
43a81887-42b8-43b5-b58a-3f3df2e9949b	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
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 table
NDC	Effective	Related label
63629-3204-1	2020-10-12	Nortriptyline Hydrochloride Capsules, USP Rx only
63629-3204-1	2020-10-12	Nortriptyline Hydrochloride Capsules, USP Rx only
63629-3204-2	2020-10-12	Nortriptyline Hydrochloride Capsules, USP Rx only
63629-3204-2	2020-10-12	Nortriptyline Hydrochloride Capsules, USP Rx only
63629-3204-3	2020-10-12	Nortriptyline Hydrochloride Capsules, USP Rx only
63629-3204-3	2020-10-12	Nortriptyline Hydrochloride Capsules, USP Rx only
63629-3204-4	2020-10-12	Nortriptyline Hydrochloride Capsules, USP Rx only
63629-3204-4	2020-10-12	Nortriptyline Hydrochloride Capsules, USP Rx only
63629-3204-5	2020-10-12	Nortriptyline Hydrochloride Capsules, USP Rx only
63629-3204-5	2020-10-12	Nortriptyline Hydrochloride Capsules, USP Rx only
63629-3204-6	2020-10-12	Nortriptyline Hydrochloride Capsules, USP Rx only
63629-3204-6	2020-10-12	Nortriptyline Hydrochloride Capsules, USP Rx only
63629-3204-1	2020-01-31	Nortriptyline Hydrochloride Capsules, USP Rx only
63629-3204-1	2020-01-31	Nortriptyline Hydrochloride Capsules, USP Rx only
63629-3204-2	2020-01-31	Nortriptyline Hydrochloride Capsules, USP Rx only
63629-3204-2	2020-01-31	Nortriptyline Hydrochloride Capsules, USP Rx only
63629-3204-3	2020-01-31	Nortriptyline Hydrochloride Capsules, USP Rx only
63629-3204-3	2020-01-31	Nortriptyline Hydrochloride Capsules, USP Rx only
63629-3204-4	2020-01-31	Nortriptyline Hydrochloride Capsules, USP Rx only
63629-3204-4	2020-01-31	Nortriptyline Hydrochloride Capsules, USP Rx only
63629-3204-5	2020-01-31	Nortriptyline Hydrochloride Capsules, USP Rx only
63629-3204-5	2020-01-31	Nortriptyline Hydrochloride Capsules, USP Rx only
63629-3204-6	2020-01-31	Nortriptyline Hydrochloride Capsules, USP Rx only
63629-3204-6	2020-01-31	Nortriptyline Hydrochloride Capsules, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
63629-3204-1	Nortriptyline Hydrochloride	30 in 1 BOTTLE	CAPSULE	30	1009
63629-3204-2	Nortriptyline Hydrochloride	60 in 1 BOTTLE	CAPSULE	60	1009
63629-3204-3	Nortriptyline Hydrochloride	90 in 1 BOTTLE	CAPSULE	90	1009
63629-3204-4	Nortriptyline Hydrochloride	100 in 1 BOTTLE	CAPSULE	100	1009
63629-3204-5	Nortriptyline Hydrochloride	120 in 1 BOTTLE	CAPSULE	120	1009
63629-3204-6	Nortriptyline Hydrochloride	15 in 1 BOTTLE	CAPSULE	15	1009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63629-3204-1	EA - Each	63629-3204	1bce2098-b266-4776-85c2-e455b6678105	1	2013-02-13
63629-3204-2	EA - Each	63629-3204	d1900608-db59-457f-93cc-97bb9ca88929	1	2013-02-13
63629-3204-3	EA - Each	63629-3204	b87404b9-9603-4f3b-ae8e-f308e2e13d8f	1	2013-02-13
63629-3204-4	EA - Each	63629-3204	d3c78e72-6002-46c9-b46e-48de37d4a5a4	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
NORTRIPTYLINE HYDROCHLORIDE	ACTIVE INGREDIENT	00FN6IH15D	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]	1001
NORTRIPTYLINE	ACTIVE MOIETY	BL03SY4LXB	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]	1001
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]	1001
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]	1001
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]	1001
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]	1001
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]	1001
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]	1001
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]	1001
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]	1001
GELATIN	INACTIVE INGREDIENT	2G86QN327L	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]	1001
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]	1001
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]	1001
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]	1001
SHELLAC	INACTIVE INGREDIENT	46N107B71O	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]	1001
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]	1001
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]	1001
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]	1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63629-3204	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]	1008	Current NDC, Legacy NDC, 6 package rows	20240320_43a81887-42b8-43b5-b58a-3f3df2e9949b.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.

Matched openFDA labels page 1 of 1 · 17 matching rows.

Brand, Generic, Manufacturer table
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	Exact identifier application applno (ANDA): 074132 application number: ANDA074132
Nortriptyline Hydrochloride	NORTRIPTYLINE HYDROCHLORIDE	REMEDYREPACK INC.	522d0cd8-d84d-4961-a525-4527fce44c3c	2026-06-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074132 application number: ANDA074132
Nortriptyline Hydrochloride	NORTRIPTYLINE HYDROCHLORIDE	A-S Medication Solutions	a2cf7783-7019-49ea-ab55-796674d94546	2026-03-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074132 application number: ANDA074132
Nortriptyline Hydrochloride	NORTRIPTYLINE HYDROCHLORIDE	Bryant Ranch Prepack	8eef261f-5c78-a88f-37c4-46e6b0e0f0ee	2026-03-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074132 application number: ANDA074132
Nortriptyline Hydrochloride	NORTRIPTYLINE HYDROCHLORIDE	Coupler LLC	4c21abdb-f3e9-9037-e063-6294a90af4b4	2026-03-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074132 application number: ANDA074132
NORTRIPTYLINE HYDROCHLORIDE	NORTRIPTYLINE HYDROCHLORIDE	Direct Rx	017f7717-e160-4142-9a5a-1a2bd9776707	2026-01-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074132 application number: ANDA074132
Nortriptyline Hydrochloride	NORTRIPTYLINE HYDROCHLORIDE	American Health Packaging	d111c36d-98ed-4f0d-97ea-86fe9048deee	2025-12-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074132 application number: ANDA074132
Nortriptyline Hydrochloride	NORTRIPTYLINE HYDROCHLORIDE	A-S Medication Solutions	686d15d0-6434-42ec-8c78-f45d617d294c	2025-12-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074132 application number: ANDA074132
Nortriptyline Hydrochloride	NORTRIPTYLINE HYDROCHLORIDE	Bryant Ranch Prepack	962f3f54-0556-4509-a231-ca62cb01bec8	2025-11-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074132 application number: ANDA074132
Nortriptyline Hydrochloride	NORTRIPTYLINE HYDROCHLORIDE	Bryant Ranch Prepack	43a81887-42b8-43b5-b58a-3f3df2e9949b	2025-11-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074132 application number: ANDA074132 ndc (package): 63629-3204-5 ndc (product): 63629-3204 ndc11 (package): 63629320405
Nortriptyline Hydrochloride	NORTRIPTYLINE HYDROCHLORIDE	Teva Pharmaceuticals USA, Inc.	b58d473a-b19f-4d2a-b1ae-dd398d7a29e1	2025-09-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074132 application number: ANDA074132
Nortriptyline Hydrochloride	NORTRIPTYLINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	af950b46-07df-4de6-a221-d3d7059b87a1	2025-08-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074132 application number: ANDA074132
Nortriptyline Hydrochloride	NORTRIPTYLINE HYDROCHLORIDE	Proficient Rx LP	e047f990-c374-4f8f-8583-c615f92545e2	2024-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074132 application number: ANDA074132
Nortriptyline Hydrochloride	NORTRIPTYLINE HYDROCHLORIDE	Proficient Rx LP	2f9fc7a0-163a-4a05-84a7-7999a41ecb1f	2024-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074132 application number: ANDA074132
Nortriptyline Hydrochloride	NORTRIPTYLINE HYDROCHLORIDE	Proficient Rx LP	b387ba49-fd3f-4488-86e8-9b81e85ab232	2024-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074132 application number: ANDA074132
Nortriptyline Hydrochloride	NORTRIPTYLINE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	f1868790-c70b-4979-974d-3ce0ffe99e36	2024-02-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074132 application number: ANDA074132
Nortriptyline Hydrochloride	NORTRIPTYLINE HYDROCHLORIDE	Proficient Rx LP	30263e15-de21-4db4-aceb-59d619909e82	2023-03-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074132 application number: ANDA074132

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
00FN6IH15D	NORTRIPTYLINE HYDROCHLORIDE	894-71-3	NORTRIPTYLINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
198045	nortriptyline HCl 10 MG Oral Capsule	PSN	43a81887-42b8-43b5-b58a-3f3df2e9949b	1009
198045	nortriptyline 10 MG Oral Capsule	SCD	43a81887-42b8-43b5-b58a-3f3df2e9949b	1009
198045	nortriptyline (as nortriptyline HCl) 10 MG Oral Capsule	SY	43a81887-42b8-43b5-b58a-3f3df2e9949b	1009

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-3204-5	63629320405	120 CAPSULE in 1 BOTTLE (63629-3204-5)	120 capsule	2011-05-10	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Nortriptyline Hydrochloride Capsules, USP Rx only	Bryant Ranch Prepack	2025-11-07	HUMAN PRESCRIPTION DRUG LABEL	1009