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 1.

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
2026-08-01 22:54:322026-06A217953-001IPRATROPIUM BROMIDE0.021MG/INHAEROSOL, METERED / INHALATIONAB2026-02-23a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A217953-001AB1a50c72e98297…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-08-01 22:54:322026-06A217953-001PC2026-10-13a50c72e98297…

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
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

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

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