PAMELOR

Product NDC
0406-9912
11-digit product format
004069912
Labeler code
0406
Product ID
0406-9912_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
50 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 1.

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 4 · 132 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2024-11-08 22:44 UTC · 2 captures of this ZIP2024-11N018013-001PAMELOREQ 10MG BASECAPSULE / ORALABRLD, Approved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 2 captures of this ZIP2024-11N018013-002PAMELOREQ 25MG BASECAPSULE / ORALABRLD, Approved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 2 captures of this ZIP2024-11N018013-003PAMELOREQ 75MG BASECAPSULE / ORALABRLD, RS, Approved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 2 captures of this ZIP2024-11N018013-004PAMELOREQ 50MG BASECAPSULE / ORALABRLD, Approved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N018013-001PAMELOREQ 10MG BASECAPSULE / ORALABRLD, Approved before 1982d06236e962d9…
2024-10-29 15:01 UTC2024-10N018013-002PAMELOREQ 25MG BASECAPSULE / ORALABRLD, Approved before 1982d06236e962d9…
2024-10-29 15:01 UTC2024-10N018013-003PAMELOREQ 75MG BASECAPSULE / ORALABRLD, RS, Approved before 1982d06236e962d9…
2024-10-29 15:01 UTC2024-10N018013-004PAMELOREQ 50MG BASECAPSULE / ORALABRLD, Approved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018013-001PAMELOREQ 10MG BASECAPSULE / ORALABRLD, Approved before 198279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018013-002PAMELOREQ 25MG BASECAPSULE / ORALABRLD, Approved before 198279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018013-003PAMELOREQ 75MG BASECAPSULE / ORALABRLD, RS, Approved before 198279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018013-004PAMELOREQ 50MG BASECAPSULE / ORALABRLD, Approved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018013-001PAMELOREQ 10MG BASECAPSULE / ORALABRLD, Approved before 1982301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018013-002PAMELOREQ 25MG BASECAPSULE / ORALABRLD, Approved before 1982301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018013-003PAMELOREQ 75MG BASECAPSULE / ORALABRLD, RS, Approved before 1982301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018013-004PAMELOREQ 50MG BASECAPSULE / ORALABRLD, Approved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018013-001PAMELOREQ 10MG BASECAPSULE / ORALABRLD, Approved before 19821e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018013-002PAMELOREQ 25MG BASECAPSULE / ORALABRLD, Approved before 19821e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018013-003PAMELOREQ 75MG BASECAPSULE / ORALABRLD, RS, Approved before 19821e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018013-004PAMELOREQ 50MG BASECAPSULE / ORALABRLD, Approved before 19821e350fbaab3a…
2024-05-31 18:47 UTC2024-05N018013-001PAMELOREQ 10MG BASECAPSULE / ORALABRLD, Approved before 19828072bd15b7f6…
2024-05-31 18:47 UTC2024-05N018013-002PAMELOREQ 25MG BASECAPSULE / ORALABRLD, Approved before 19828072bd15b7f6…
2024-05-31 18:47 UTC2024-05N018013-003PAMELOREQ 75MG BASECAPSULE / ORALABRLD, RS, Approved before 19828072bd15b7f6…
2024-05-31 18:47 UTC2024-05N018013-004PAMELOREQ 50MG BASECAPSULE / ORALABRLD, Approved before 19828072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N018013-001PAMELOREQ 10MG BASECAPSULE / ORALABRLD, Approved before 19825c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N018013-002PAMELOREQ 25MG BASECAPSULE / ORALABRLD, Approved before 19825c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N018013-003PAMELOREQ 75MG BASECAPSULE / ORALABRLD, RS, Approved before 19825c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N018013-004PAMELOREQ 50MG BASECAPSULE / ORALABRLD, Approved before 19825c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N018013-001PAMELOREQ 10MG BASECAPSULE / ORALABRLD, Approved before 19825d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N018013-002PAMELOREQ 25MG BASECAPSULE / ORALABRLD, Approved before 19825d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N018013-003PAMELOREQ 75MG BASECAPSULE / ORALABRLD, RS, Approved before 19825d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N018013-004PAMELOREQ 50MG BASECAPSULE / ORALABRLD, Approved before 19825d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N018013-001PAMELOREQ 10MG BASECAPSULE / ORALABRLD, Approved before 19824b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N018013-002PAMELOREQ 25MG BASECAPSULE / ORALABRLD, Approved before 19824b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N018013-003PAMELOREQ 75MG BASECAPSULE / ORALABRLD, RS, Approved before 19824b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N018013-004PAMELOREQ 50MG BASECAPSULE / ORALABRLD, Approved before 19824b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N018013-001PAMELOREQ 10MG BASECAPSULE / ORALABRLD, Approved before 198274a2ff9319b5…
2019-12-13 00:20 UTC2019-12N018013-002PAMELOREQ 25MG BASECAPSULE / ORALABRLD, Approved before 198274a2ff9319b5…
2019-12-13 00:20 UTC2019-12N018013-003PAMELOREQ 75MG BASECAPSULE / ORALABRLD, RS, Approved before 198274a2ff9319b5…
2019-12-13 00:20 UTC2019-12N018013-004PAMELOREQ 50MG BASECAPSULE / ORALABRLD, Approved before 198274a2ff9319b5…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 128 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-11-08 22:44 UTC · 2 captures of this ZIP2024-11N018013-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 2 captures of this ZIP2024-11N018013-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 2 captures of this ZIP2024-11N018013-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 2 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…
2022-04-04 05:41 UTC2022-04N018013-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N018013-002AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N018013-003AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N018013-004AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N018013-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N018013-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N018013-003AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N018013-004AB174a2ff9319b5…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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): 0406-9912

Additional Listing Data#

Finished product
Yes
Brand name base
PAMELOR

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NORTRIPTYLINE HYDROCHLORIDE50 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
0406-9912-03PAMELOR30 in 1 BOTTLECAPSULE3024

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0406-9912-03EA - Each0406-9912c9e06482-c671-436c-a627-0a564132ddad12012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0406-9912PAMELOR (NORTRIPTYLINE HYDROCHLORIDE) CAPSULE [SPECGX LLC]23Current NDC, Legacy NDC, 1 package rows20241208_e17dc299-f52d-414d-ab6e-e809bd6f8acb.zip

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
0406-9912-030040699120330 CAPSULE in 1 BOTTLE (0406-9912-03) 30 capsule1977-08-012027-11-30NoNoCurrent