What is NDC 43975-323?

43975-323 is the product NDC for Tolterodine Tartrate, Tolterodine tartrate 4 mg/1 capsule, extended release, listed with the FDA by ANI Pharmaceuticals, Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.

ANI Pharmaceuticals, Inc., NDC labeler code 43975. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Tolterodine Tartrate?

31 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Tolterodine Tartrate NDC 43975-323

NDC codes

FDA NDC Directory

Product NDC (as listed)43975-323Labeler and product segments. Claims need a package NDC.

Product NDC at billing width43975-0323Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package
43975-323-03	4397503230343975032303	30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (43975-323-03)Marketed from Aug 29, 2019
43975-323-09	4397503230943975032309	90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (43975-323-09)Marketed from Aug 29, 2019
43975-323-50	4397503235043975032350	500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (43975-323-50)Marketed from Aug 29, 2019

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Tolterodine Tartrate
Generic name (nonproprietary): tolterodine tartrate
Active ingredients: Tolterodine tartrate — 4 mg/1
Dosage form: Capsule, Extended release
Route: Oral
Labeler: ANI Pharmaceuticals, Inc.NDC labeler code 43975
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 204562
Marketing start: Aug 29, 2019
Listing expires: Dec 31, 2026
Other FDA classes: Cholinergic Muscarinic Antagonists (Mechanism)
Identifiers: Product ID 43975-323_361c4d47-0750-6f78-e063-6394a90ab0c0SPL ID 361c4d47-0750-6f78-e063-6394a90ab0c0SPL set ID fc5bdc4a-a483-4d31-807b-c7f8d8869723RxCUI 855182, 855189UNII 5T619TQR3RUPC 0343975323034, 0343975322037
Pharmacologic class: Cholinergic Muscarinic Antagonist

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N443975032303 followed by a unit qualifier and the quantity

Package 43975-0323-03. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Apr 1, 2025.

Indications (excerpt from the label)

1. INDICATIONS AND USAGE Tolterodine tartrate extended-release capsules, USP are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency [see CLINICAL STUDIES (14) ] . Tolterodine tartrate extended-release capsules, USP are an antimuscarinic indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. (1)

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 43975-323

What is NDC 43975-323?: 43975-323 is the product NDC for Tolterodine Tartrate, Tolterodine tartrate 4 mg/1 capsule, extended release, listed with the FDA by ANI Pharmaceuticals, Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Tolterodine Tartrate.
What is the active ingredient?: Tolterodine tartrate.
Who is the labeler?: ANI Pharmaceuticals, Inc., NDC labeler code 43975. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Tolterodine Tartrate?: 31 other product NDCs are listed under this name. See all Tolterodine Tartrate NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Tolterodine Tartrate NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Tolterodine Tartrate	Tolterodine tartrate 2 mg/1	Capsule, Extended releaseOral	Major Pharmaceuticals	0904-7574	00904-7574-04
Tolterodine Tartrate	Tolterodine tartrate 4 mg/1	Capsule, Extended releaseOral	Major Pharmaceuticals	0904-7575	00904-7575-04
Tolterodine tartrate	Tolterodine tartrate 4 mg/1	Capsule, Extended releaseOral	Unichem Pharmaceuticals (USA), Inc.	29300-307	29300-0307-0529300-0307-1329300-0307-19
Tolterodine tartrate	Tolterodine tartrate 2 mg/1	Capsule, Extended releaseOral	Unichem Pharmaceuticals (USA), Inc.	29300-306	29300-0306-0529300-0306-1329300-0306-19
Tolterodine Tartrate	Tolterodine tartrate 2 mg/1	Tablet, Film coatedOral	Camber Pharmaceuticals, Inc.	31722-806	31722-0806-0131722-0806-0231722-0806-05+1 more
Tolterodine Tartrate	Tolterodine tartrate 1 mg/1	Tablet, Film coatedOral	Camber Pharmaceuticals, Inc.	31722-805	31722-0805-0131722-0805-0231722-0805-05+1 more
Tolterodine Tartrate	Tolterodine tartrate 2 mg/1	Capsule, Extended releaseOral	Slate Run Pharmaceuticals, LLC	70436-160	70436-0160-0270436-0160-0470436-0160-06
Tolterodine Tartrate	Tolterodine tartrate 4 mg/1	Capsule, Extended releaseOral	Slate Run Pharmaceuticals, LLC	70436-161	70436-0161-0270436-0161-0470436-0161-06
Tolterodine tartrate	Tolterodine tartrate 2 mg/1	Tablet, Film coatedOral	Macleods Pharmaceuticals Limited	33342-098	33342-0098-0933342-0098-1233342-0098-15
Tolterodine tartrate	Tolterodine tartrate 1 mg/1	Tablet, Film coatedOral	Macleods Pharmaceuticals Limited	33342-097	33342-0097-0933342-0097-1233342-0097-15

All 32 Tolterodine Tartrate NDCs

Other NDCs under ANDA 204562

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 204562
Product	Strength	Form · route	Labeler	Product NDC
Tolterodine Tartrate	Tolterodine tartrate 2 mg/1	Capsule, Extended releaseOral	Major Pharmaceuticals	0904-7574
Tolterodine Tartrate	Tolterodine tartrate 4 mg/1	Capsule, Extended releaseOral	Major Pharmaceuticals	0904-7575
Tolterodine Tartrate	Tolterodine tartrate 2 mg/1	Capsule, Extended releaseOral	Golden State Medical Supply, Inc.	51407-739
Tolterodine Tartrate	Tolterodine tartrate 4 mg/1	Capsule, Extended releaseOral	Golden State Medical Supply, Inc.	51407-740
Tolterodine Tartrate	Tolterodine tartrate 2 mg/1	Capsule, Extended releaseOral	ANI Pharmaceuticals, Inc.	43975-322