FDA.reportPublic FDA data

Ipratropium Bromide Inhalation

Product NDC
17270-0401
11-digit product format
172700401
Labeler code
17270
Product ID
17270-0401_be83ceac-679d-42c3-960d-536709b5df99
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ipratropium Bromide Inhalation
Dosage form
AEROSOL
Route
RESPIRATORY (INHALATION)
Labeler
Armstrong Pharmaceuticals, Inc.
Application
ANDA217953
Marketing category
ANDA
Marketing start
2026-04-16
Substance
IPRATROPIUM BROMIDE
Active strength
17 ug/1
Pharmacologic classes
Anticholinergic [EPC], Cholinergic Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A217953-001IPRATROPIUM BROMIDEIPRATROPIUM BROMIDE0.021MG/INHAEROSOL, METERED / INHALATIONAB2026-02-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A217953-001AB

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 1 matching rows.

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
A217953-001PC2026-10-13

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A217953-001IPRATROPIUM BROMIDE0.021MG/INHAEROSOL, METERED / INHALATIONAB2026-02-23caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217953-001IPRATROPIUM BROMIDE0.021MG/INHAEROSOL, METERED / INHALATIONAB2026-02-23a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A217953-001AB1caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217953-001AB1a50c72e98297…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-08-18 06:07:402026-07A217953-001PC2026-10-13caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217953-001PC2026-10-13a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
Ipratropium Bromide Inhalation
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IPRATROPIUM BROMIDE17 ug/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
J697UZ2A9JInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
836343Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
133cc2ed-f018-4295-b84e-b24382299360Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9ccc399f-9de9-4e86-a0ca-d7a2e7c6c36cProduct name220251106
d953267a-4ca0-4d44-91ad-712cdee8ab38Product name220250630
0a278166-c8aa-41b6-b4a5-6ac332bde76aProduct name120230718
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
6ac73021-459f-435b-b6c5-8c7d6a50c021Product name220170404
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17270-0401-0Ipratropium Bromide Inhalation200 in 1 CANISTERAEROSOL2002
17270-0401-0Ipratropium Bromide Inhalation1 in 1 CARTONAEROSOL12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17270-0401-0GM - Gram17270-04010864eda2-1a2a-4f4b-a90e-a80d3921818312026-04-20

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
Ipratropium Bromide InhalationIPRATROPIUM BROMIDE INHALATIONArmstrong Pharmaceuticals, Inc.133cc2ed-f018-4295-b84e-b243822993602026-04-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217953
application number: ANDA217953
ndc (product): 17270-0401

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
836343ipratropium bromide 17 MCG/INHAL Metered Dose Inhaler, 200 ActuationsPSN133cc2ed-f018-4295-b84e-b243822993602
836343200 ACTUAT ipratropium bromide 0.017 MG/ACTUAT Metered Dose InhalerSCD133cc2ed-f018-4295-b84e-b243822993602
836343ipratropium bromide 0.017 MG/ACTUAT Metered Dose Inhaler, 200 ACTUATSY133cc2ed-f018-4295-b84e-b243822993602
836343ipratropium bromide 17 MCG/ACTUAT Metered Dose Inhaler, 200 ACTUATSY133cc2ed-f018-4295-b84e-b243822993602

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
17270-0401-0172700401001 CANISTER in 1 CARTON (17270-0401-0) / 200 AEROSOL in 1 CANISTER1 canister2026-04-16NoNoCurrent