Propranolol Hydrochloride

Product NDC
50090-7097
11-digit product format
500907097
Labeler code
50090
Product ID
50090-7097_57597f08-363f-431f-b18d-dba64a349d85
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Propranolol Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA071972
Marketing category
ANDA
Marketing start
2021-06-03
Substance
PROPRANOLOL HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A071972-001PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB1988-04-06
A071972-002PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDE20MGTABLET / ORALAB1988-04-06
A071972-003PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB1988-04-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A071972-001AB
A071972-002AB
A071972-003AB

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 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A071972-001PROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB1988-04-06caaa826d4ba7…
2026-08-18 06:07:402026-07A071972-002PROPRANOLOL HYDROCHLORIDE20MGTABLET / ORALAB1988-04-06caaa826d4ba7…
2026-08-18 06:07:402026-07A071972-003PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB1988-04-06caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A071972-001PROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB1988-04-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A071972-002PROPRANOLOL HYDROCHLORIDE20MGTABLET / ORALAB1988-04-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A071972-003PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB1988-04-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071972-001PROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB1988-04-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071972-002PROPRANOLOL HYDROCHLORIDE20MGTABLET / ORALAB1988-04-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071972-003PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB1988-04-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A071972-001PROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB1988-04-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A071972-002PROPRANOLOL HYDROCHLORIDE20MGTABLET / ORALAB1988-04-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A071972-003PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB1988-04-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071972-001PROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB1988-04-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071972-002PROPRANOLOL HYDROCHLORIDE20MGTABLET / ORALAB1988-04-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071972-003PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB1988-04-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071972-001PROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB1988-04-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071972-002PROPRANOLOL HYDROCHLORIDE20MGTABLET / ORALAB1988-04-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071972-003PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB1988-04-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071972-001PROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB1988-04-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071972-002PROPRANOLOL HYDROCHLORIDE20MGTABLET / ORALAB1988-04-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071972-003PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB1988-04-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071972-001PROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB1988-04-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071972-002PROPRANOLOL HYDROCHLORIDE20MGTABLET / ORALAB1988-04-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071972-003PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB1988-04-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071972-001PROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB1988-04-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071972-002PROPRANOLOL HYDROCHLORIDE20MGTABLET / ORALAB1988-04-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071972-003PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB1988-04-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071972-001PROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB1988-04-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071972-002PROPRANOLOL HYDROCHLORIDE20MGTABLET / ORALAB1988-04-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071972-003PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB1988-04-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A071972-001PROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB1988-04-06d06236e962d9…
2024-10-29 15:01 UTC2024-10A071972-002PROPRANOLOL HYDROCHLORIDE20MGTABLET / ORALAB1988-04-06d06236e962d9…
2024-10-29 15:01 UTC2024-10A071972-003PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB1988-04-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071972-001PROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB1988-04-0679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071972-002PROPRANOLOL HYDROCHLORIDE20MGTABLET / ORALAB1988-04-0679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071972-003PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB1988-04-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071972-001PROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB1988-04-06301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071972-002PROPRANOLOL HYDROCHLORIDE20MGTABLET / ORALAB1988-04-06301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071972-003PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB1988-04-06301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071972-001PROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB1988-04-061e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 114 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A071972-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A071972-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A071972-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A071972-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A071972-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A071972-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071972-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071972-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071972-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A071972-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A071972-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A071972-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071972-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071972-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071972-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071972-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071972-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071972-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071972-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071972-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071972-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071972-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071972-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071972-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071972-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071972-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071972-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071972-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071972-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071972-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A071972-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A071972-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A071972-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071972-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071972-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071972-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071972-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071972-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071972-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071972-001AB11e350fbaab3a…

Additional Listing Data#

Finished product
Yes
Brand name base
Propranolol Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PROPRANOLOL HYDROCHLORIDE10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
F8A3652H1VInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
856448Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d1110a10-a7f4-4295-9e94-8fbb56f77f67Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-7097-0Propranolol Hydrochloride40 in 1 BOTTLETABLET402
50090-7097-1Propranolol Hydrochloride100 in 1 BOTTLETABLET1002
50090-7097-5Propranolol Hydrochloride90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7097-0EA - Each50090-7097f22e5937-092e-4ea5-82e2-c175dbf1571812024-03-12
50090-7097-1EA - Each50090-7097a5ef3776-fdaa-4f65-91ce-ba5312ad2ef712024-03-12
50090-7097-5EA - Each50090-709733e503f9-5ecb-4829-b657-bf9362e1352312024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-7097PROPRANOLOL HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS]2Current NDC, 3 package rows20240229_d1110a10-a7f4-4295-9e94-8fbb56f77f67.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 2 · 25 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEREMEDYREPACK INC.a3bd3ef9-539d-450e-900b-95be0e46095b2026-08-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071972
application number: ANDA071972
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEREMEDYREPACK INC.e3f615e0-07da-491c-9620-7083f4f4318a2026-08-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071972
application number: ANDA071972
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEREMEDYREPACK INC.1cd914b6-b250-4b11-8404-41db3589361e2026-08-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071972
application number: ANDA071972
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.49d09308-74b0-4f9a-9c03-37234b5ee3a32026-07-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071972
application number: ANDA071972
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.95a2eacd-b6b7-4e92-ae14-52fbee6c65432026-07-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071972
application number: ANDA071972
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEMajor Pharmaceuticalse7218c9b-b9b8-4cf0-a2c7-c759ad3a65ba2026-07-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071972
application number: ANDA071972
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDENorthwind Health Company, LLC03afbc5a-a9dc-e823-e063-6394a90a0cb22026-06-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071972
application number: ANDA071972
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDESt. Mary's Medical Park Pharmacy42def694-9484-a2ca-e063-6394a90a87d82026-06-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071972
application number: ANDA071972
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDECoupler LLC53e65732-3acf-597a-e063-6294a90a31912026-06-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071972
application number: ANDA071972
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEAmneal Pharmaceuticals NY LLC14d0c95d-418f-40a8-bad3-e20c824249602026-06-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071972
application number: ANDA071972
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEAvPAK039b415b-094a-da37-e063-6294a90a52d72026-01-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071972
application number: ANDA071972
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDENorthwind Health Company, LLCf2b68e23-2a9d-76b4-e053-2995a90a375a2026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071972
application number: ANDA071972
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDENorthwind Health Company, LLCf76b7edc-6d7d-9cba-e053-6294a90a035c2026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071972
application number: ANDA071972
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEPreferred Pharmaceuticals Inc.d9759182-e681-4c7e-af36-9f7b2184df3c2025-09-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071972
application number: ANDA071972
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEPreferred Pharmaceuticals Inc.1791ef4d-b609-41c8-b4ef-15bff752ddd72025-09-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071972
application number: ANDA071972
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEBryant Ranch Prepack1d79ba59-6346-46c0-8e63-470e2069238e2025-08-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071972
application number: ANDA071972
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEBryant Ranch Prepackc139587f-fdfa-4efe-a39e-452f7c39e6572025-08-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071972
application number: ANDA071972
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEBryant Ranch Prepacka21eb31b-db50-47a5-8f4c-315c2a842c8b2025-08-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071972
application number: ANDA071972
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDECardinal Health 107, LLC74dc9949-010c-4f2c-9aef-63ab466ba6572025-02-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071972
application number: ANDA071972
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEAdvanced Rx of Tennessee, LLC29acc74e-79b5-f668-e063-6394a90aef9b2024-12-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071972
application number: ANDA071972

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856448propranolol HCl 10 MG Oral TabletPSNd1110a10-a7f4-4295-9e94-8fbb56f77f672
856448propranolol hydrochloride 10 MG Oral TabletSCDd1110a10-a7f4-4295-9e94-8fbb56f77f672

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-7097-05009070970040 TABLET in 1 BOTTLE (50090-7097-0) 40 tablet2024-02-22NoNoCurrent
50090-7097-150090709701100 TABLET in 1 BOTTLE (50090-7097-1) 100 tablet2024-02-27NoNoCurrent
50090-7097-55009070970590 TABLET in 1 BOTTLE (50090-7097-5) 90 tablet2024-02-27NoNoCurrent