PAMELOR

Product NDC
0406-9910
11-digit product format
004069910
Labeler code
0406
Product ID
0406-9910_0c3b20b3-e852-4959-815a-90ed989a30e1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nortriptyline hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
SpecGx LLC
Application
NDA018013
Marketing category
NDA
Marketing start
1977-08-01
Marketing end
2027-11-30
Substance
NORTRIPTYLINE HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Tricyclic Antidepressant [EPC]
NDC exclude flag
No
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N018013-001PAMELORNORTRIPTYLINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALRLD, Approved before 1982
N018013-002PAMELORNORTRIPTYLINE HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALRLD, Approved before 1982
N018013-003PAMELORNORTRIPTYLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALRLD, Approved before 1982
N018013-004PAMELORNORTRIPTYLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALRLD, Approved before 1982

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 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N018013-001PAMELOREQ 10MG BASECAPSULE / ORALRLD, Approved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07N018013-002PAMELOREQ 25MG BASECAPSULE / ORALRLD, Approved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07N018013-003PAMELOREQ 75MG BASECAPSULE / ORALRLD, Approved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07N018013-004PAMELOREQ 50MG BASECAPSULE / ORALRLD, Approved before 1982caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N018013-001PAMELOREQ 10MG BASECAPSULE / ORALRLD, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018013-002PAMELOREQ 25MG BASECAPSULE / ORALRLD, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018013-003PAMELOREQ 75MG BASECAPSULE / ORALRLD, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018013-004PAMELOREQ 50MG BASECAPSULE / ORALRLD, Approved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018013-001PAMELOREQ 10MG BASECAPSULE / ORALRLD, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018013-002PAMELOREQ 25MG BASECAPSULE / ORALRLD, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018013-003PAMELOREQ 75MG BASECAPSULE / ORALRLD, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018013-004PAMELOREQ 50MG BASECAPSULE / ORALRLD, Approved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08N018013-001PAMELOREQ 10MG BASECAPSULE / ORALRLD, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018013-002PAMELOREQ 25MG BASECAPSULE / ORALRLD, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018013-003PAMELOREQ 75MG BASECAPSULE / ORALRLD, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018013-004PAMELOREQ 50MG BASECAPSULE / ORALRLD, Approved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018013-001PAMELOREQ 10MG BASECAPSULE / ORALRLD, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018013-002PAMELOREQ 25MG BASECAPSULE / ORALRLD, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018013-003PAMELOREQ 75MG BASECAPSULE / ORALRLD, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018013-004PAMELOREQ 50MG BASECAPSULE / ORALRLD, Approved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018013-001PAMELOREQ 10MG BASECAPSULE / ORALRLD, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018013-002PAMELOREQ 25MG BASECAPSULE / ORALRLD, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018013-003PAMELOREQ 75MG BASECAPSULE / ORALRLD, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018013-004PAMELOREQ 50MG BASECAPSULE / ORALRLD, Approved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018013-001PAMELOREQ 10MG BASECAPSULE / ORALRLD, Approved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018013-002PAMELOREQ 25MG BASECAPSULE / ORALRLD, Approved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018013-003PAMELOREQ 75MG BASECAPSULE / ORALRLD, Approved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018013-004PAMELOREQ 50MG BASECAPSULE / ORALRLD, Approved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018013-001PAMELOREQ 10MG BASECAPSULE / ORALABRLD, Approved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018013-002PAMELOREQ 25MG BASECAPSULE / ORALABRLD, Approved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018013-003PAMELOREQ 75MG BASECAPSULE / ORALABRLD, RS, Approved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018013-004PAMELOREQ 50MG BASECAPSULE / ORALABRLD, Approved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018013-001PAMELOREQ 10MG BASECAPSULE / ORALABRLD, Approved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018013-002PAMELOREQ 25MG BASECAPSULE / ORALABRLD, Approved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018013-003PAMELOREQ 75MG BASECAPSULE / ORALABRLD, RS, Approved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018013-004PAMELOREQ 50MG BASECAPSULE / ORALABRLD, Approved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018013-001PAMELOREQ 10MG BASECAPSULE / ORALABRLD, Approved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018013-002PAMELOREQ 25MG BASECAPSULE / ORALABRLD, Approved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018013-003PAMELOREQ 75MG BASECAPSULE / ORALABRLD, RS, Approved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018013-004PAMELOREQ 50MG BASECAPSULE / ORALABRLD, Approved before 1982d8e5a09893c0…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 136 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018013-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018013-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018013-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018013-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018013-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018013-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018013-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018013-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018013-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018013-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018013-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018013-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N018013-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N018013-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N018013-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N018013-004AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018013-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018013-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018013-003AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018013-004AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018013-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018013-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018013-003AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018013-004AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018013-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018013-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018013-003AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018013-004AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N018013-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05N018013-002AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05N018013-003AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05N018013-004AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N018013-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N018013-002AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N018013-003AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N018013-004AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N018013-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N018013-002AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N018013-003AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N018013-004AB15d02ea3f76ae…

Additional Listing Data#

Finished product
Yes
Brand name base
PAMELOR

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NORTRIPTYLINE HYDROCHLORIDE10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
00FN6IH15DInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 8 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198045Internal RxNorm lookup
198046Internal RxNorm lookup
198047Internal RxNorm lookup
209329Internal RxNorm lookup
209339Internal RxNorm lookup
209350Internal RxNorm lookup
209391Internal RxNorm lookup
317136Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e17dc299-f52d-414d-ab6e-e809bd6f8acbAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
de76de11-1019-6138-2d8a-16fa566ae22aProduct name220241009
53e88688-54e1-9681-22b8-e499bd715088Product name220210729

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0406-9910-03PAMELOR30 in 1 BOTTLECAPSULE3024

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0406-9910-03EA - Each0406-991035c17e73-a9a8-402a-971d-1b36429eb45912012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0406-9910PAMELOR (NORTRIPTYLINE HYDROCHLORIDE) CAPSULE [SPECGX LLC]23Current NDC, Legacy NDC, 1 package rows20241208_e17dc299-f52d-414d-ab6e-e809bd6f8acb.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PAMELORNORTRIPTYLINE HYDROCHLORIDESpecGx LLCe17dc299-f52d-414d-ab6e-e809bd6f8acb2024-12-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 018013
application number: NDA018013
ndc (product): 0406-9910

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198045nortriptyline HCl 10 MG Oral CapsulePSNe17dc299-f52d-414d-ab6e-e809bd6f8acb24
317136nortriptyline HCl 25 MG Oral CapsulePSNe17dc299-f52d-414d-ab6e-e809bd6f8acb24
198046nortriptyline HCl 50 MG Oral CapsulePSNe17dc299-f52d-414d-ab6e-e809bd6f8acb24
198047nortriptyline HCl 75 MG Oral CapsulePSNe17dc299-f52d-414d-ab6e-e809bd6f8acb24
209329Pamelor 10 MG Oral CapsulePSNe17dc299-f52d-414d-ab6e-e809bd6f8acb24
209339Pamelor 25 MG Oral CapsulePSNe17dc299-f52d-414d-ab6e-e809bd6f8acb24
209350Pamelor 50 MG Oral CapsulePSNe17dc299-f52d-414d-ab6e-e809bd6f8acb24
209391Pamelor 75 MG Oral CapsulePSNe17dc299-f52d-414d-ab6e-e809bd6f8acb24
209329nortriptyline 10 MG Oral Capsule [Pamelor]SBDe17dc299-f52d-414d-ab6e-e809bd6f8acb24
209339nortriptyline 25 MG Oral Capsule [Pamelor]SBDe17dc299-f52d-414d-ab6e-e809bd6f8acb24
209350nortriptyline 50 MG Oral Capsule [Pamelor]SBDe17dc299-f52d-414d-ab6e-e809bd6f8acb24
209391nortriptyline 75 MG Oral Capsule [Pamelor]SBDe17dc299-f52d-414d-ab6e-e809bd6f8acb24
198045nortriptyline 10 MG Oral CapsuleSCDe17dc299-f52d-414d-ab6e-e809bd6f8acb24
317136nortriptyline 25 MG Oral CapsuleSCDe17dc299-f52d-414d-ab6e-e809bd6f8acb24
198046nortriptyline 50 MG Oral CapsuleSCDe17dc299-f52d-414d-ab6e-e809bd6f8acb24
198047nortriptyline 75 MG Oral CapsuleSCDe17dc299-f52d-414d-ab6e-e809bd6f8acb24
198045nortriptyline (as nortriptyline HCl) 10 MG Oral CapsuleSYe17dc299-f52d-414d-ab6e-e809bd6f8acb24
317136nortriptyline (as nortriptyline HCl) 25 MG Oral CapsuleSYe17dc299-f52d-414d-ab6e-e809bd6f8acb24
198046nortriptyline (as nortriptyline HCl) 50 MG Oral CapsuleSYe17dc299-f52d-414d-ab6e-e809bd6f8acb24
198047nortriptyline (as nortriptyline HCl) 75 MG Oral CapsuleSYe17dc299-f52d-414d-ab6e-e809bd6f8acb24
209329Pamelor (nortriptyline hydrochloride) 10 MG Oral CapsuleSYe17dc299-f52d-414d-ab6e-e809bd6f8acb24
209339Pamelor (nortriptyline hydrochloride) 25 MG Oral CapsuleSYe17dc299-f52d-414d-ab6e-e809bd6f8acb24
209350Pamelor (nortriptyline hydrochloride) 50 MG Oral CapsuleSYe17dc299-f52d-414d-ab6e-e809bd6f8acb24
209391Pamelor (nortriptyline hydrochloride) 75 MG Oral CapsuleSYe17dc299-f52d-414d-ab6e-e809bd6f8acb24
209329Pamelor 10 MG Oral CapsuleSYe17dc299-f52d-414d-ab6e-e809bd6f8acb24
209339Pamelor 25 MG Oral CapsuleSYe17dc299-f52d-414d-ab6e-e809bd6f8acb24
209350Pamelor 50 MG Oral CapsuleSYe17dc299-f52d-414d-ab6e-e809bd6f8acb24
209391Pamelor 75 MG Oral CapsuleSYe17dc299-f52d-414d-ab6e-e809bd6f8acb24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0406-9910-030040699100330 CAPSULE in 1 BOTTLE (0406-9910-03) 30 capsule1977-08-012027-11-30NoNoCurrent