Prescription drug · ANDA

Memantine hydrochloride NDC 70771-1323

Memantine hydrochloride 21 mg/1 · Capsule, Extended release · Oral · Zydus Lifesciences Limited

NDC codes

FDA NDC Directory
Product NDC (as listed)70771-1323Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70771-1323Add 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 NDC11-digit (billing)PackageCopy
70771-1323-37077113230330 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70771-1323-3)Marketed from Apr 8, 2018
70771-1323-47077113230410 BLISTER PACK in 1 CARTON (70771-1323-4) / 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (70771-1323-2)Marketed from Apr 8, 2018
70771-1323-97077113230990 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70771-1323-9)Marketed from Apr 8, 2018

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
Memantine hydrochloride
Generic name (nonproprietary)
memantine hydrochloride
Active ingredients
Memantine hydrochloride — 21 mg/1
Dosage form
Capsule, Extended release
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 203293
Marketing start
Listing expires
Other FDA classes
NMDA Receptor Antagonists (Mechanism)
Identifiers
Product ID 70771-1323_900483ef-de89-464c-a324-8bfaa8f137a6SPL ID 900483ef-de89-464c-a324-8bfaa8f137a6SPL set ID ec825bef-2313-45c2-8858-b43197680155RxCUI 996594, 996603, 996609, 996615UNII JY0WD0UA60
Pharmacologic class
N-methyl-D-aspartate Receptor 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

N470771132303 followed by a unit qualifier and the quantity

Package 70771-1323-03. 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 .

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 203293

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

FDA NDC Directory listings under ANDA 203293
ProductStrengthForm · routeLabelerProduct NDC
Memantine hydrochlorideMemantine hydrochloride 7 mg/1Capsule, Extended releaseOralZydus Pharmaceuticals USA Inc.68382-546
Memantine hydrochlorideMemantine hydrochloride 28 mg/1Capsule, Extended releaseOralZydus Pharmaceuticals USA Inc.68382-549
Memantine hydrochlorideMemantine hydrochloride 14 mg/1Capsule, Extended releaseOralZydus Pharmaceuticals USA Inc.68382-547
Memantine hydrochlorideMemantine hydrochloride 21 mg/1Capsule, Extended releaseOralZydus Pharmaceuticals USA Inc.68382-548
Memantine hydrochlorideMemantine hydrochloride 7 mg/1Capsule, Extended releaseOralZydus Lifesciences Limited70771-1321
Memantine hydrochlorideMemantine hydrochloride 14 mg/1Capsule, Extended releaseOralZydus Lifesciences Limited70771-1322
Memantine hydrochlorideMemantine hydrochloride 28 mg/1Capsule, Extended releaseOralZydus Lifesciences Limited70771-1324

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Memantine hydrochloride NDC 70771-1323 | Med-Code