Propranolol Hydrochloride

Product NDC
60429-127
Requested package NDC
60429-127-05
11-digit product format
604290127
Labeler code
60429
Product ID
60429-127_c137d572-6f4d-2fcd-e053-2995a90a8e56
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Propranolol Hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA078494
Marketing category
ANDA
Marketing start
2014-07-15
Marketing end
0000-00-00
Substance
PROPRANOLOL HYDROCHLORIDE
Active strength
80 mg/1
Pharmacologic classes
Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage60429-12760429-127-05DDiscontinued by firm2026-08-11

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60429-127-01EA - Each60429-1278bae8c7b-8dd2-4f03-aab1-e4f12aa4ee1412015-01-05
60429-127-05EA - Each60429-127da6439d8-5ab8-4db6-907b-cedf6f31e08912015-01-05

DailyMed Socrata Ingredients#

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

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60429-127-0560429012705500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (60429-127-05) 2014-07-150000-00-00NoNoCurrent