Propranolol Hydrochloride

Product NDC
68151-3071
11-digit product format
681513071
Labeler code
68151
Product ID
68151-3071_bb877d74-46ba-40ef-9f50-65e6ec7234c9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Propranolol Hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Carilion Materials Management
Application
ANDA078494
Marketing category
ANDA
Marketing start
2007-08-10
Marketing end
0000-00-00
Substance
PROPRANOLOL HYDROCHLORIDE
Active strength
60 mg/1
Pharmacologic classes
Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]
NDC exclude flag
E
Listing certified through
2018-12-31
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.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68151-3071IInactivated by FDA2026-08-11
excluded packagepackage68151-307168151-3071-1IInactivated by FDA2026-08-11

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 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68151-3071-1IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68151-3071-1IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68151-3071-1IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68151-3071-1IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68151-3071-1IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68151-3071-1IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68151-3071-1IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68151-3071-1IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68151-3071-1IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68151-3071-1IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage68151-3071-1IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68151-3071-1IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage68151-3071-1IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage68151-3071-1IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage68151-3071-1IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage68151-3071-1IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage68151-3071-1IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage68151-3071-1IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage68151-3071-1IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage68151-3071-1IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage68151-3071-1IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage68151-3071-1EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

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
A078494-001PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDE60MGCAPSULE, EXTENDED RELEASE / ORALAB2007-08-10
A078494-002PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDE80MGCAPSULE, EXTENDED RELEASE / ORALAB2007-08-10
A078494-003PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB2007-08-10
A078494-004PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDE160MGCAPSULE, EXTENDED RELEASE / ORALAB2007-08-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A078494-001AB
A078494-002AB
A078494-003AB
A078494-004AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A078494-001PROPRANOLOL HYDROCHLORIDE60MGCAPSULE, EXTENDED RELEASE / ORALAB2007-08-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078494-002PROPRANOLOL HYDROCHLORIDE80MGCAPSULE, EXTENDED RELEASE / ORALAB2007-08-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078494-003PROPRANOLOL HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB2007-08-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078494-004PROPRANOLOL HYDROCHLORIDE160MGCAPSULE, EXTENDED RELEASE / ORALAB2007-08-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078494-001PROPRANOLOL HYDROCHLORIDE60MGCAPSULE, EXTENDED RELEASE / ORALAB2007-08-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078494-002PROPRANOLOL HYDROCHLORIDE80MGCAPSULE, EXTENDED RELEASE / ORALAB2007-08-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078494-003PROPRANOLOL HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB2007-08-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078494-004PROPRANOLOL HYDROCHLORIDE160MGCAPSULE, EXTENDED RELEASE / ORALAB2007-08-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08A078494-001PROPRANOLOL HYDROCHLORIDE60MGCAPSULE, EXTENDED RELEASE / ORALAB2007-08-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078494-002PROPRANOLOL HYDROCHLORIDE80MGCAPSULE, EXTENDED RELEASE / ORALAB2007-08-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078494-003PROPRANOLOL HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB2007-08-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078494-004PROPRANOLOL HYDROCHLORIDE160MGCAPSULE, EXTENDED RELEASE / ORALAB2007-08-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078494-001PROPRANOLOL HYDROCHLORIDE60MGCAPSULE, EXTENDED RELEASE / ORALAB2007-08-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078494-002PROPRANOLOL HYDROCHLORIDE80MGCAPSULE, EXTENDED RELEASE / ORALAB2007-08-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078494-003PROPRANOLOL HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB2007-08-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078494-004PROPRANOLOL HYDROCHLORIDE160MGCAPSULE, EXTENDED RELEASE / ORALAB2007-08-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078494-001PROPRANOLOL HYDROCHLORIDE60MGCAPSULE, EXTENDED RELEASE / ORALAB2007-08-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078494-002PROPRANOLOL HYDROCHLORIDE80MGCAPSULE, EXTENDED RELEASE / ORALAB2007-08-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078494-003PROPRANOLOL HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB2007-08-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078494-004PROPRANOLOL HYDROCHLORIDE160MGCAPSULE, EXTENDED RELEASE / ORALAB2007-08-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078494-001PROPRANOLOL HYDROCHLORIDE60MGCAPSULE, EXTENDED RELEASE / ORALAB2007-08-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078494-002PROPRANOLOL HYDROCHLORIDE80MGCAPSULE, EXTENDED RELEASE / ORALAB2007-08-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078494-003PROPRANOLOL HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB2007-08-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078494-004PROPRANOLOL HYDROCHLORIDE160MGCAPSULE, EXTENDED RELEASE / ORALAB2007-08-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078494-001PROPRANOLOL HYDROCHLORIDE60MGCAPSULE, EXTENDED RELEASE / ORALAB2007-08-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078494-002PROPRANOLOL HYDROCHLORIDE80MGCAPSULE, EXTENDED RELEASE / ORALAB2007-08-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078494-003PROPRANOLOL HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB2007-08-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078494-004PROPRANOLOL HYDROCHLORIDE160MGCAPSULE, EXTENDED RELEASE / ORALAB2007-08-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078494-001PROPRANOLOL HYDROCHLORIDE60MGCAPSULE, EXTENDED RELEASE / ORALAB2007-08-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078494-002PROPRANOLOL HYDROCHLORIDE80MGCAPSULE, EXTENDED RELEASE / ORALAB2007-08-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078494-003PROPRANOLOL HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB2007-08-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078494-004PROPRANOLOL HYDROCHLORIDE160MGCAPSULE, EXTENDED RELEASE / ORALAB2007-08-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078494-001PROPRANOLOL HYDROCHLORIDE60MGCAPSULE, EXTENDED RELEASE / ORALAB2007-08-10d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078494-002PROPRANOLOL HYDROCHLORIDE80MGCAPSULE, EXTENDED RELEASE / ORALAB2007-08-10d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078494-003PROPRANOLOL HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB2007-08-10d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078494-004PROPRANOLOL HYDROCHLORIDE160MGCAPSULE, EXTENDED RELEASE / ORALAB2007-08-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078494-001PROPRANOLOL HYDROCHLORIDE60MGCAPSULE, EXTENDED RELEASE / ORALAB2007-08-10d06236e962d9…
2024-10-29 15:01 UTC2024-10A078494-002PROPRANOLOL HYDROCHLORIDE80MGCAPSULE, EXTENDED RELEASE / ORALAB2007-08-10d06236e962d9…
2024-10-29 15:01 UTC2024-10A078494-003PROPRANOLOL HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB2007-08-10d06236e962d9…
2024-10-29 15:01 UTC2024-10A078494-004PROPRANOLOL HYDROCHLORIDE160MGCAPSULE, EXTENDED RELEASE / ORALAB2007-08-10d06236e962d9…

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A078494-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078494-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078494-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078494-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078494-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078494-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078494-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078494-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078494-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078494-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078494-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078494-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078494-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078494-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078494-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078494-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078494-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078494-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078494-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078494-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078494-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078494-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078494-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078494-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078494-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078494-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078494-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078494-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078494-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078494-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078494-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078494-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078494-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078494-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078494-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078494-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078494-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078494-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078494-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078494-004AB1d06236e962d9…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ba1babb5-1c2a-d9a8-0fd7-8f90d4f768cfProduct name220200609
a5696e6c-a559-4d6b-bb53-f324106f317cProduct name120140718
0f446d3d-c9e6-1844-b8e8-a836dc35e0deProduct name120140508
33a4b7b4-a3c1-3f95-a202-01166dd77c44Product name120140508
60519d27-227d-404a-38bc-37524c8b386bProduct name120140508
d5f30598-8f94-b083-f161-65d67f2ae12aProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68151-3071-12020-01-31C16284748780-19d75b9d0-4372-f424-e053-dadaa90a57cePROPRANOLOL HYDROCHLORIDE EXTENDED-RELEASE CAPSULES, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68151-3071-1Propranolol Hydrochloride1 in 1 PACKAGECAPSULE, EXTENDED RELEASE14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PROPRANOLOL HYDROCHLORIDEACTIVE INGREDIENTF8A3652H1VPROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
PROPRANOLOLACTIVE MOIETY9Y8NXQ24VQPROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GPROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4BPROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKPROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAPROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTPROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357PROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
GELATININACTIVE INGREDIENT2G86QN327LPROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PPROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
POVIDONE K29/32INACTIVE INGREDIENT390RMW2PEQPROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3PROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
SUCROSEINACTIVE INGREDIENTC151H8M554PROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
TALCINACTIVE INGREDIENT7SEV7J4R1UPROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68151-3071PROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]4Legacy NDC, 1 package rows20171228_37438047-b456-4e85-a7cc-3eb688908cfe.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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEActavis Pharma, Inc.a4edba76-29b8-41fb-bf0b-d4633abba0032025-09-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078494
application number: ANDA078494
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEProficient Rx LP968353ed-eb79-4f96-9569-3efb220fc3882023-02-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078494
application number: ANDA078494
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEProficient Rx LPe4009ade-155b-4d28-8a8d-555db68bf8b02023-02-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078494
application number: ANDA078494

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856535propranolol HCl 60 MG 24HR Extended Release Oral CapsulePSN37438047-b456-4e85-a7cc-3eb688908cfe4
85653524 HR propranolol hydrochloride 60 MG Extended Release Oral CapsuleSCD37438047-b456-4e85-a7cc-3eb688908cfe4
856535propranolol hydrochloride 60 MG 24 HR Extended Release Oral CapsuleSY37438047-b456-4e85-a7cc-3eb688908cfe4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68151-3071-1681513071011 in 1 PACKAGEHistorical